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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05381909




Registration number
NCT05381909
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022

Titles & IDs
Public title
A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors
Scientific title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and With Combination Therapies in Patients With Solid Tumors
Secondary ID [1] 0 0
CTR20232532
Secondary ID [2] 0 0
BGB-24714-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-24714
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Docetaxel

Experimental: Phase 1a: Dose Escalation Part A - Participants will receive escalating doses of BGB-24714 as monotherapy

Experimental: Phase 1a: Dose Escalation Part B - Participants will receive increasing dose levels of BGB-24714 in combination with paclitaxel

Experimental: Phase 1a: Dose Escalation Part C - Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation

Experimental: Phase 1a: Dose Escalation Part D - Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation

Experimental: Phase 1a: Dose Escalation Part A-CN - Participants will receive escalating doses of BGB-24714 as monotherapy in Chinese participants

Experimental: Phase 1a: Dose Escalation Part E - Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants

Experimental: Phase 1b: Dose Expansion - BGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors.


Treatment: Drugs: BGB-24714
administered orally

Treatment: Drugs: Paclitaxel
administered intravenously

Treatment: Drugs: Carboplatin
administered intravenously

Treatment: Drugs: Docetaxel
administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation: Number of participants with adverse events (AEs)
Timepoint [1] 0 0
approximately 6 months
Primary outcome [2] 0 0
Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
Timepoint [2] 0 0
approximately 6 months
Primary outcome [3] 0 0
Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
Timepoint [3] 0 0
approximately 6 months
Primary outcome [4] 0 0
Dose Expansion: Objective response rate (ORR)
Timepoint [4] 0 0
approximately 2 Years
Secondary outcome [1] 0 0
Dose Escalation: Objective response rate (ORR)
Timepoint [1] 0 0
approximately 2 Years
Secondary outcome [2] 0 0
Dose Expansion: Progression-free Survival (PFS)
Timepoint [2] 0 0
approximately 2 Years
Secondary outcome [3] 0 0
Dose Expansion: Number of participants with adverse events
Timepoint [3] 0 0
approximately 2 Years
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
approximately 2 Years
Secondary outcome [5] 0 0
Disease Control Rate (DCR)
Timepoint [5] 0 0
approximately 2 Years
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR)
Timepoint [6] 0 0
approximately 2 Years
Secondary outcome [7] 0 0
Plasma Concentrations of BGB-24714 and its metabolite
Timepoint [7] 0 0
approximately 2 Years
Secondary outcome [8] 0 0
Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite
Timepoint [8] 0 0
Up to 48 hours postdose
Secondary outcome [9] 0 0
Time to Maximum Plasma Concentration (Tmax) of BGB-24714 and its metabolite
Timepoint [9] 0 0
Up to 48 hours postdose
Secondary outcome [10] 0 0
Terminal Half-life (t1/2) of BGB-24714 and its metabolite
Timepoint [10] 0 0
Up to 48 hours postdose
Secondary outcome [11] 0 0
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of BGB-24714 and its metabolite
Timepoint [11] 0 0
Up to 48 hours postdose
Secondary outcome [12] 0 0
Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite
Timepoint [12] 0 0
Up to 48 hours postdose
Secondary outcome [13] 0 0
Apparent Clearance (CL/F) of BGB-24714
Timepoint [13] 0 0
Up to 48 hours postdose
Secondary outcome [14] 0 0
Apparent Volume Of Distribution (Vz/F) of BGB-24714
Timepoint [14] 0 0
Up to 48 hours postdose
Secondary outcome [15] 0 0
Concentration at steady state (Cmax,ss) of BGB-24714 and its metabolite
Timepoint [15] 0 0
Up to 48 hours postdose
Secondary outcome [16] 0 0
Time to Maximum Plasma Concentration at steady state (Tmax,ss) of BGB-24714 and its metabolite
Timepoint [16] 0 0
Up to 48 hours postdose
Secondary outcome [17] 0 0
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration at Steady State (AUClast,ss) of BGB-24714 and its metabolite
Timepoint [17] 0 0
Up to 48 hours postdose
Secondary outcome [18] 0 0
Rough Concentration At Steady State (Ctrough,ss) of BGB-24714 and its metabolite
Timepoint [18] 0 0
Up to 48 hours postdose

Eligibility
Key inclusion criteria
Key Eligibility Criteria :

1. Participants must sign a written informed consent form (ICF); and agree to comply with study requirement
2. Phase 1a (Dose Escalation):

Part A, A-CN, and B: Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor previously treated with standard systemic therapy or for whom treatment is not available or not tolerated Note: Only Chinese participants will be eligible for Part A-CN.

Part C: Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III Non-small cell lung cancer (NSCLC) suitable for definitive chemoradiotherapy (CRT)

Part D: Participant with locally advanced, histologically confirmed inoperable esophageal squamous cell carcinoma (ESCC) suitable for definitive CRT

Phase 1b (Dose Expansion): Participants with histologically or cytologically confirmed solid tumors of selected types previously treated with standard therapy.
3. Participants must be able to provide formalin-fixed paraffin embedded (FFPE) tumor tissue sample.
4. Phase 1a Part A, A-CN, B and Phase 1b: = 1 measurable lesion per Response evaluation criteria in solid tumors (RECIST) v1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1

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, untreated brain metastasis.
2. Any malignancy = 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
3. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication = 14 days before the first dose of study drug(s).
4. Clinically significant infection requiring systemic therapy = 14 days before the first dose of study drug(s).
5. Prior exposure to agents with second mitochondria-derived activator of caspases (SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
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
6/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
South Dakota
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
China
State/province [8] 0 0
Chongqing
Country [9] 0 0
China
State/province [9] 0 0
Hunan
Country [10] 0 0
China
State/province [10] 0 0
Shandong
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Gyeonggi-do
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Incheon Gwang'yeogsi
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul Teugbyeolsi
Country [14] 0 0
New Zealand
State/province [14] 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/NCT05381909