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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05006716
Registration number
NCT05006716
Ethics application status
Date submitted
9/08/2021
Date registered
16/08/2021
Date last updated
24/06/2025
Titles & IDs
Public title
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
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Scientific title
A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies
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Secondary ID [1]
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2022-502157-33-00
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Secondary ID [2]
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BGB-16673-101
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Universal Trial Number (UTN)
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Trial acronym
CaDAnCe-101
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
B-cell Malignancy
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Marginal Zone Lymphoma
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Follicular Lymphoma
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Non-Hodgkin Lymphoma
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Waldenström Macroglobulinemia
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Chronic Lymphocytic Leukemia
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Small Lymphocytic Lymphoma
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Mantle Cell Lymphoma
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Diffuse Large B Cell Lymphoma
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Condition category
Condition code
Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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0
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-16673
Experimental: Part 1a (Monotherapy Dose Escalation) - Dose escalation in specific subtypes of non-Hodgkin lymphoma (NHL), including relapsed or refractory (R/R) marginal zone lymphoma (MZL), relapsed or refractory (R/R) follicular lymphoma (FL) Grades 1, 2, and 3a, relapsed or refractory (R/R) mantle cell lymphoma (MCL), relapsed or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), relapsed or refractory (R/R) Richter's transformation (RT), and relapsed or refractory (R/R) Waldenström macroglobulinemia (WM), to evaluate the safety and tolerability of BGB-16673.
Experimental: Part 1b (Monotherapy Safety Expansion) - Participants with R/R MZL, MCL, CLL/SLL, and WM will be enrolled at selected doses to help determine the recommended dose(s) for expansion (RDFE(s)) for BGB-16673.
Experimental: Part 1c (Additional Monotherapy Safety Expansion) - Additional safety data will be collected from participants with R/R MZL, WM, RT, DLBCL, or FL to confirm the RDFE(s) of BGB-16673 for those with non-CLL/SLL/MCL histologies.
Experimental: Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL) - Participants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for BGB-16673.
Experimental: Part 1e (Japan-only Cohort) - Japanese participants with R/R MZL, FL, MCL, CLL/SLL, and WM will be enrolled at selected RDFE(s) to assess the safety and tolerability of BGB-16673.
Experimental: Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies) - Participants with CLL/SLL, MCL, WM, MZL, or Richter's transformation to DLBCL who have not received a prior BTKi (either covalent or noncovalent) will be enrolled at selected dose levels.
Experimental: Phase 2 (Monotherapy Expansion) - Cohorts of participants with R/R CLL/SLL, R/R MCL, R/R WM, R/R MZL, R/R FL, R/R RT, and R/R DLBCL will be enrolled to recieve the RDFE(s) identified in Phase 1 to further evaluate the safety and efficacy of BGB-16673.
Treatment: Drugs: BGB-16673
Orally administered
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1: Number of Participants with Adverse Events (AEs)
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Assessment method [1]
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Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
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Timepoint [1]
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From the first dose of BGB-16673 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)
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Primary outcome [2]
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Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-16673
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Assessment method [2]
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MTD is defined as the highest evaluated dose with an estimated toxicity rate closest to the target, while MAD is the highest dose given if MTD is not reached.
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Timepoint [2]
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Approximately 28 days
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Primary outcome [3]
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Phase 1: Recommended dose(s) for Expansion (RDFE) of BGB-16673
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Assessment method [3]
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RDFE of BGB-16673 alone will be determined based upon the MTD or MAD.
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Timepoint [3]
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Approximately 28 days
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Primary outcome [4]
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Phase 2: Overall response rate (ORR)
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Assessment method [4]
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Defined as the percentage of participants achieving a best overall response of partial response (PR) or better, assessed by the Independent Review Committee for participants with R/R CLL/SLL and R/R MCL and by the investigator for other cohorts (R/R WM, R/R FL, R/R non-GCB DLBCL, R/R Ritchter's transformation to DLBCL), evaluated using the Lugano criteria for NHL and SLL, iwCLL criteria for CLL, and IWWM-6 criteria for WM.
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Timepoint [4]
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approximately 3 years
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Secondary outcome [1]
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Single dose and steady-state maximum observed plasma concentration (Cmax) of BGB-16673
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Assessment method [1]
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Timepoint [1]
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Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [2]
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Single dose and steady-state minimum observed plasma concentration (Cmin) of BGB-16673
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Assessment method [2]
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Timepoint [2]
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Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [3]
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Single dose and steady-state time to reach Cmax (tmax) of BGB-16673
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Assessment method [3]
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Timepoint [3]
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Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [4]
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Single dose and steady-state time to reach half of Cmax (T1/2) of BGB-16673
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Assessment method [4]
0
0
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Timepoint [4]
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Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [5]
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Single dose and steady-state area under the plasma concentration-time curve (AUC) of BGB-16673
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Assessment method [5]
0
0
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Timepoint [5]
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Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [6]
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Single dose and steady-state apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
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Assessment method [6]
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0
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Timepoint [6]
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Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [7]
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Single dose and steady-state apparent volume of distribution (Vz/F) of BGB-16673
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Assessment method [7]
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0
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Timepoint [7]
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Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [8]
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Single dose and steady-state accumulation ratios of BGB-16673
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Assessment method [8]
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Timepoint [8]
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Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [9]
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Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after BGB-16673 monotherapy
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Assessment method [9]
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Timepoint [9]
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Week 1 Day 1 pre-dose; 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose and 8 hours post-dose; Week 9 Day 1 pre-dose.
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Secondary outcome [10]
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Phase 1: Overall response rate (ORR)
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Assessment method [10]
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Defined as the percentage of participants whose best overall response is better than stable disease, as assessed by the investigator and evaluated according to the following criteria: the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for R/R CLL, the International Workshop on Waldenström's Macroglobulinemia (IWWM-6) criteria for R/R WM, and the Lugano criteria for R/R NHL.
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Timepoint [10]
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approximately 3 years
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Secondary outcome [11]
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Phase 1: Number of R/R WM Participants with major response rate (MRR)
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Assessment method [11]
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MRR is defined as the percentage of participants whose best overall response (BOR) is partial response (PR) or better (PR, very good partial response (VGPR), or complete response (CR)) as assessed by the investigator and evaluated per the IWWM-6 criteria.
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Timepoint [11]
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approximately 3 years
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Secondary outcome [12]
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Phase 1: Number of Participants with AEs in part 1e (Japan-only cohort )
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Assessment method [12]
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Number of Japanese participants in Part 1e with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, that meet protocol-defined DLTs, graded according to the NCI-CTCAE v5.0.
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Timepoint [12]
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From the first dose of BGB-16673 in Part 1e until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
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Secondary outcome [13]
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Phase 2: Recommended Phase 2 Dose (RP2D)
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Assessment method [13]
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Defined as the dose of a drug recommended for use in Phase 2 clinical trials, the Recommended Phase 2 Dose (RP2D) is determined by the sponsor based on the Safety Monitoring Committee's recommendations, taking into account the overall clinical safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data.
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Timepoint [13]
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approximately 3 years
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Secondary outcome [14]
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Phase 2: Number of Participants with AEs
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Assessment method [14]
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Number of participants with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, that meet protocol-defined DLTs, graded according to the NCI-CTCAE v5.0.
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Timepoint [14]
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From the first dose of BGB-16673 in Phase 2 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
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Secondary outcome [15]
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Phase 2: Complete Response Rate (CRR)
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Assessment method [15]
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CRR for participants in Cohort 2 (R/R blastoid or nonblastoid variant R/R MCL) is defined as the percentage of participants who achieve a complete response (CR), as determined by both the Independent Review Committee (IRC) and investigators.
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Timepoint [15]
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approximately 3 years
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Secondary outcome [16]
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Phase 2: Response rate of minor response or better
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Assessment method [16]
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Defined as the percentage of participants who achieve at least a minor response (MR) or a more favorable outcome, as assessed by investigators for cohort 3 (R/R WM)
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Timepoint [16]
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approximately 3 years
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Secondary outcome [17]
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Phase 2: Duration of Response (DOR)
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Assessment method [17]
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DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is documented or death, whichever comes first as assessed by the investigator and the IRC.
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Timepoint [17]
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approximately 3 years
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Secondary outcome [18]
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Phase 2: Time to Response (TTR)
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Assessment method [18]
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TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator
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Timepoint [18]
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approximately 3 years
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Secondary outcome [19]
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Phase 2: Progression- Free Survival (PFS)
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Assessment method [19]
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PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC and the investigator
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Timepoint [19]
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approximately 3 years
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Secondary outcome [20]
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Phase 2: Overall Survival (OS)
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Assessment method [20]
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OS is defined as the time from first study drug administration to the date of death due to any cause
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Timepoint [20]
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approximately 3 years
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Secondary outcome [21]
0
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Phase 2: Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionaire
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Assessment method [21]
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Mean change from baseline in the 'physical well-being' and 'functional well-being' subscales of the FACT-Leu for Cohort 1 participants (R/R CLL/SLL). FACT-Leu is a 44-item PRO questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients.
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Timepoint [21]
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Baseline and day 1 of Weeks 5, 13, 25, and 37
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Secondary outcome [22]
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Phase 2: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 (NFLymSI-18)
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Assessment method [22]
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Mean change from baseline in the NFlymSI-18 subscales of disease-related symptoms (DRSP) and 'treatment side effects' for Cohort 2 participants (R/R MCL). The NFlymSI-18 is an 18-item patient-reported outcome (PRO) tool specifically designed to assess symptoms and treatment impacts in patients with non-Hodgkin lymphoma.
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Timepoint [22]
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Baseline and day 1 of Weeks 5, 13, 25, and 37
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Eligibility
Key inclusion criteria
Inclusion Criteria :
1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL) , Follicular Lymphoma (FL), R/R Mantle Cell Lymphoma (MCL), R/R chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), Diffuse large B-cell lymphoma (DLBCL), or >2 treatments per the Richter's transformation to DLBCL.
2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for = 8 weeks (unless reason for discontinuation is intolerance).
3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
4. Measurable disease by radiographic assessment or serum IgM level (WM only)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
6. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score = 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
2. Requires ongoing systemic treatment for any other malignancy
3. Requires ongoing systemic (defined as = 10 mg/day of prednisone or equivalent) corticosteroid treatment.
4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
621
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [3]
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0
Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
0
0
St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [5]
0
0
Peninsula Private Hospital - Frankston
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Recruitment hospital [6]
0
0
Austin Health - Heidelberg
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Recruitment hospital [7]
0
0
Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [8]
0
0
The Alfred Hospital - Melbourne
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Recruitment hospital [9]
0
0
Linear Clinical Research - Nedlands
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Recruitment hospital [10]
0
0
Perth Blood Institute - West Perth
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Recruitment postcode(s) [1]
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0
2139 - Concord
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Recruitment postcode(s) [2]
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0
2298 - Waratah
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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0
3199 - Frankston
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Recruitment postcode(s) [6]
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0
3084 - Heidelberg
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Recruitment postcode(s) [7]
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0
3000 - Melbourne
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Recruitment postcode(s) [8]
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0
3004 - Melbourne
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Recruitment postcode(s) [9]
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0
6009 - Nedlands
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Recruitment postcode(s) [10]
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6005 - West Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Iowa
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Kentucky
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Louisiana
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Maryland
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Massachusetts
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Michigan
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Minnesota
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Nevada
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Country [16]
0
0
United States of America
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State/province [16]
0
0
New York
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Tennessee
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Texas
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Virginia
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Washington
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Country [21]
0
0
Brazil
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State/province [21]
0
0
Brasilia
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Country [22]
0
0
Brazil
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State/province [22]
0
0
Caxias do Sul
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Country [23]
0
0
Brazil
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State/province [23]
0
0
Curitiba
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Country [24]
0
0
Brazil
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State/province [24]
0
0
Porto Alegre
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Country [25]
0
0
Brazil
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State/province [25]
0
0
Sao Paulo
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Country [26]
0
0
Brazil
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State/province [26]
0
0
Vitoria
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Country [27]
0
0
Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Calgary
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Canada
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Quebec
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France
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Bordeaux
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France
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Clermontferrand
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France
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Creteil
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France
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Lille
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France
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Lyon Cedex
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France
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Marseille
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France
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Montpellier
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France
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Paris
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France
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Rouen Cedex
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Georgia
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Tbilisi
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Germany
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Dresden
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Germany
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Koln
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Germany
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Leipzig
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Germany
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Luebeck
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Germany
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Mainz
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Germany
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Munchen
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Germany
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Ulm
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Italy
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Bologna
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Italy
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Milano
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Italy
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Roma
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Italy
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Verona
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Tokyo
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Japan
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YokohamaShi
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Korea, Republic of
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Busan Gwang'yeogsi
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Korea, Republic of
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Seoul Teugbyeolsi
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Moldova, Republic of
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Chisinau
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Stockholm
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Sweden
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Uppsala
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Turkey
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Abidinpaa
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Turkey
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Ankara
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Turkey
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Balcova
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Turkey
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Kayseri
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Turkey
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Sakarya
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Turkey
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Samsun
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United Kingdom
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Edinburgh
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United Kingdom
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Headington
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United Kingdom
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Leeds
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United Kingdom
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NewCastle Upon Tyne
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
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Trial website
https://clinicaltrials.gov/study/NCT05006716
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Public notes
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Contacts
Principal investigator
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Study Director
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BeiGene
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Contact person for public queries
Name
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BeiGene
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Address
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Phone
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1.877.828.5568
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
See plan description
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Available to whom?
See plan description
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://beigene.com/science/clinical-trials/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05006716
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