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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04649385




Registration number
NCT04649385
Ethics application status
Date submitted
25/11/2020
Date registered
2/12/2020

Titles & IDs
Public title
BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors
Scientific title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
CTR20212721
Secondary ID [2] 0 0
BGB-A317-15025-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-15025
Treatment: Drugs - Tislelizumab

Experimental: Phase 1a: Dose Escalation - Part A: Participants will receive once daily of BGB-15025 monotherapy in sequential cohorts of approximately 7 increasing doses

Part B: Participants will receive once daily of BGB-15025 in sequential cohorts plus 200mg tislelizumab on day 1 of each 21-day cycle (combination therapy )

Experimental: Phase 1b: Dose Expansion - Phase 1b dose expansion will begin based upon the recommended doses for expansion (RDFE) for BGB-15025 alone or in combination with tislelizumab, and with or without chemotherapy as determined from Phase 1a


Treatment: Drugs: BGB-15025
Administered orally once or twice daily (QD or BID)

Treatment: Drugs: Tislelizumab
Administered 200 mg intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Number of participants with dose limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 3 Years
Primary outcome [2] 0 0
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Timepoint [2] 0 0
Up to 4 Years
Primary outcome [3] 0 0
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to 4 years
Primary outcome [4] 0 0
The maximum tolerated dose (MTD) of BGB-15025
Timepoint [4] 0 0
Up to 3 Years
Primary outcome [5] 0 0
Recommended Doses for Expansion (RDFE) of BGB-15025 monotherapy
Timepoint [5] 0 0
Up to 3 years
Primary outcome [6] 0 0
RDFE of BGB-15025 in combination with tislelizumab
Timepoint [6] 0 0
Up to 3 years
Primary outcome [7] 0 0
Phase 1b: Overall Response Rate (ORR) as assessed by the investigator
Timepoint [7] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Phase 1a: Overall Response Rate (ORR) as assessed by the investigator
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Duration Of Response (DOR) as assessed by the investigator
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR) as assessed by the investigator
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-15025
Timepoint [4] 0 0
Predose up to 8 hours postdose
Secondary outcome [5] 0 0
Phase 1a: Minimum observed plasma concentration (Cmin) of BGB-15025
Timepoint [5] 0 0
Predose up to 8 hours postdose
Secondary outcome [6] 0 0
Phase 1a: Time to maximum plasma concentration (Tmax) of BGB-15025
Timepoint [6] 0 0
Predose up to 8 hours postdose
Secondary outcome [7] 0 0
Phase 1a: Half-life of (t1/2) of BGB-15025
Timepoint [7] 0 0
Predose up to 8 hours postdose
Secondary outcome [8] 0 0
Phase 1a: Area under the concentration-time curve (AUC) of BGB-15025
Timepoint [8] 0 0
Predose up to 8 hours postdose
Secondary outcome [9] 0 0
Phase 1a: Apparent clearance (CL/F) of BGB-15025
Timepoint [9] 0 0
Predose up to 8 hours postdose
Secondary outcome [10] 0 0
Phase 1a: Apparent volume of distribution (Vz/F) of BGB-15025
Timepoint [10] 0 0
Predose up to 8 hours postdose
Secondary outcome [11] 0 0
Phase 1a: Accumulation Ratio for Cmax of BGB-15025
Timepoint [11] 0 0
Predose up to 8 hours postdose
Secondary outcome [12] 0 0
Phase 1a: Accumulation Ratio for AUC of BGB-15025
Timepoint [12] 0 0
Predose up to 8 hours postdose
Secondary outcome [13] 0 0
Phase 1a: Metabolite to parent ratio for BGB-15025 and its metabolite
Timepoint [13] 0 0
Predose up to 8 hours postdose
Secondary outcome [14] 0 0
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Timepoint [14] 0 0
Up to 3 years
Secondary outcome [15] 0 0
Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [15] 0 0
Up to 3 years
Secondary outcome [16] 0 0
Phase 1b: Plasma Concentrations of BGB-15025
Timepoint [16] 0 0
Predose up to 8 hours postdose
Secondary outcome [17] 0 0
Phase 1b: Plasma Concentrations of the metabolite
Timepoint [17] 0 0
Predose up to 8 hours postdose
Secondary outcome [18] 0 0
Phase 1b: Number of participants with dose limiting toxicities (DLTs)
Timepoint [18] 0 0
Up to 1 year

Eligibility
Key inclusion criteria
Key

1. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused, and who have not received prior therapy targeting HPK1
2. Phase 1b (dose expansion): Participant with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors, including non-small cell lung cancer, esophageal cancer or gastric/Gastroesophageal junction cancer (other solid tumors may be included) who have progressed following systemic anticancer therapies or have no prior systemic treatment for advanced disease
3. At least 1 measurable lesion as defined per RECIST 1.1.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
5. Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin= 90 g/L, Absolute neutrophil count = 1.5 x 109/L , Serum total bilirubin = 1.5 x ULN (< 3 x ULN for participants with Gilbert syndrome ), AST and ALT= 2.5 x ULN

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active leptomeningeal disease or uncontrolled and untreated brain metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse
3. Any active malignancy = 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before the first dose of study treatment
5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Ashford Cancer Centre Research Northeast - Windsor Gardens
Recruitment hospital [3] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
5087 - Windsor Gardens
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
China
State/province [3] 0 0
Heilongjiang
Country [4] 0 0
China
State/province [4] 0 0
Henan
Country [5] 0 0
China
State/province [5] 0 0
Shanghai
Country [6] 0 0
China
State/province [6] 0 0
Sichuan
Country [7] 0 0
China
State/province [7] 0 0
Tianjin
Country [8] 0 0
China
State/province [8] 0 0
Zhejiang
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Gyeonggi-do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul Teugbyeolsi
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
+1-877-828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04649385