Study Investigating BGB-24714 as Monotherapy and in Combination With Chemotherapy in Participants With Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05381909|
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : February 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Drug: BGB-24714 Drug: Paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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 in Combination With Chemotherapy in Patients With Advanced or Metastatic Solid Tumors|
|Actual Study Start Date :||July 6, 2022|
|Estimated Primary Completion Date :||July 26, 2024|
|Estimated Study Completion Date :||January 22, 2025|
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 chemotherapy
Experimental: Phase 1b: (Dose Expansion)
Participants will receive the recommended phase 2 dose (RP2D) of BGB-24714 monotherapy or in combination with chemotherapy as determined from Phase 1a
- Dose Escalation: Number of participants with adverse events (AEs) [ Time Frame: approximately 6 months ]Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs ), and experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria.
- Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy and in combination with chemotherapy [ Time Frame: approximately 6 months ]The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate.
- Dose Escalation: Recommended Phase 2 dose (RP2D) of BGB-24714 as monotherapy and in combination with chemotherapy [ Time Frame: approximately 6 months ]Recommended dose based upon the MTD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available
- Dose Expansion: Objective response rate (ORR) [ Time Frame: approximately 2 Years ]ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Dose Escalation: Objective response rate (ORR) [ Time Frame: approximately 2 Years ]ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Dose Expansion: Progression-free Survival (PFS) [ Time Frame: approximately 2 Years ]PFS is defined as the time from the date of the first dose of study drug to the date of first documentation of disease progression as determined by the investigator using RECIST v1.1 or death, whichever occurs first
- Dose Expansion: Number of participants with adverse events [ Time Frame: approximately 2 Years ]Number of participants with AEs and SAEs
- Duration of Response (DOR) [ Time Frame: approximately 2 Years ]DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Disease Control Rate (DCR) [ Time Frame: approximately 2 Years ]DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Plasma concentration of BGB-24714 [ Time Frame: approximately 2 Years ]
- Plasma Concentrations of BGB-24714 metabolite [ Time Frame: approximately 2 Years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Eligibility Criteria:
- Patient must sign a written informed consent form (ICF); and agree to comply with study requirement.
- Phase 1a (Dose Escalation): Patients 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.
- Patients must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample. If archival tissue is not available, fresh tumor biopsy is mandatory.
- ≥ 1 measurable lesion per RECIST v1.1
- ECOG Performance Status ≤ 1
- Patient with adequate organ function
Key Exclusion Criteria:
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- 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
- Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
- Clinically significant infection requiring systemic therapy ≤ 14 days before the first dose of study drug(s).
- Any major surgical procedure ≤ 28 days before the first dose of study drug(s).
- Prior exposure to agents with Smac mimetics, or other IAP antagonists.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381909
|United States, Florida|
|Florida Cancer Specialists-Sarasota||Recruiting|
|Santa Rosa Beach, Florida, United States, 34232|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|United States, Tennessee|
|Tennessee Oncology, PLLC||Recruiting|
|Nashville, Tennessee, United States, 37203|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98109|
|Peter MacCallum Cancer Centre||Recruiting|
|Melbourne, Victoria, Australia, 3000|
|Icon Cancer Care- South Brisbane||Recruiting|
|Queensland, Australia, 4101|
|Auckland City Hospital||Recruiting|
|Auckland, New Zealand, 1023|
|Other Study ID Numbers:||
|First Posted:||May 19, 2022 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Advanced Solid Tumors
Metastatic Solid Tumors
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action