Study Stopped
The research was terminated voluntarily due to changes in the company's business strategy regarding the development of BGB-24714, rather than any safety issues.
A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors
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
2 other identifiers
interventional
157
5 countries
34
Brief Summary
This study aims to understand how safe and well-tolerated a drug called BGB-24714 is when used alone, or in combination with chemotherapy or radiation therapy, for people with advanced or spreading solid tumors. The main objective is to identify the highest tolerable dose or the highest administered dose of BGB-24714. Additionally, the study aims to identify the most suitable doses for further investigation in larger groups of participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2022
Typical duration for phase_1
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedStudy Start
First participant enrolled
July 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2025
CompletedFebruary 20, 2026
February 1, 2026
3.1 years
May 16, 2022
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Dose Escalation: Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs ), and experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria.
approximately 6 months
Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
approximately 6 months
Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
Recommended dose based upon the MTD or MAD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available
approximately 6 months
Dose Expansion: Objective response rate (ORR)
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)
approximately 2 Years
Secondary Outcomes (18)
Dose Escalation: Objective response rate (ORR)
approximately 2 Years
Dose Expansion: Progression-free Survival (PFS)
approximately 2 Years
Dose Expansion: Number of participants with adverse events
approximately 2 Years
Duration of Response (DOR)
approximately 2 Years
Disease Control Rate (DCR)
approximately 2 Years
- +13 more secondary outcomes
Study Arms (7)
Phase 1a: Dose Escalation Part A
EXPERIMENTALParticipants will receive escalating doses of BGB-24714 as monotherapy
Phase 1a: Dose Escalation Part B
EXPERIMENTALParticipants will receive increasing dose levels of BGB-24714 in combination with paclitaxel
Phase 1a: Dose Escalation Part C
EXPERIMENTALParticipants will receive increasing dose levels of BGB-24714 in combination with chemoradiation
Phase 1a: Dose Escalation Part D
EXPERIMENTALParticipants will receive increasing dose levels of BGB-24714 in combination with chemoradiation
Phase 1a: Dose Escalation Part A-CN
EXPERIMENTALParticipants will receive escalating doses of BGB-24714 as monotherapy in Chinese participants
Phase 1a: Dose Escalation Part E
EXPERIMENTALParticipants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants
Phase 1b: Dose Expansion
EXPERIMENTALBGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors.
Interventions
administered orally
administered intravenously
administered intravenously
Eligibility Criteria
You may not qualify if:
- 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).
- Prior exposure to agents with second mitochondria-derived activator of caspases (SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (34)
Banner Md Anderson Cancer Center
Gilbert, Arizona, 85234-2165, United States
Florida Cancer Specialist (Scri) Sarasota
Sarasota, Florida, 34232, United States
Scri Florida Cancer Specialists North
St. Petersburg, Florida, 33705-1449, United States
Scri Florida Cancer Specialist East
West Palm Beach, Florida, 33401-3406, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-2013, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, 15232-1309, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104-4663, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105-2108, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-7208, United States
The University of Texas Md Anderson Cancer Center (Department Gi Medical Oncology)
Houston, Texas, 77030-4000, United States
Intermountain Healthcare
Salt Lake City, Utah, 84143, United States
Next Virginia
Fairfax, Virginia, 22031, United States
University of Washington
Seattle, Washington, 98195, United States
Northern Beaches Hospital
Frenchs Forest, New South Wales, NSW 2086, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, QLD 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102, Australia
Austin Health
Heidelberg, Victoria, VIC 3084, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000, Australia
Sunshine Hospital
St Albans, Victoria, VIC 3021, Australia
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Auckland City Hospital
Auckland, 1023, New Zealand
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, 21565, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2022
First Posted
May 19, 2022
Study Start
July 6, 2022
Primary Completion
July 25, 2025
Study Completion
July 25, 2025
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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.