A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors
- Conditions
- Solid Tumor, Adult
- Interventions
- Registration Number
- NCT05381909
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
Not provided
- 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.
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1a: Dose Escalation Part C Paclitaxel Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation Phase 1a: Dose Escalation Part C BGB-24714 Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation Phase 1a: Dose Escalation Part C Carboplatin Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation Phase 1a: Dose Escalation Part D Paclitaxel Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation Phase 1a: Dose Escalation Part E Paclitaxel Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants Phase 1b: Dose Expansion Paclitaxel BGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors. Phase 1a: Dose Escalation Part E Carboplatin Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants Phase 1a: Dose Escalation Part B Paclitaxel Participants will receive increasing dose levels of BGB-24714 in combination with paclitaxel Phase 1a: Dose Escalation Part D Carboplatin Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation Phase 1a: Dose Escalation Part E BGB-24714 Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants Phase 1a: Dose Escalation Part A BGB-24714 Participants will receive escalating doses of BGB-24714 as monotherapy Phase 1a: Dose Escalation Part D BGB-24714 Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation Phase 1a: Dose Escalation Part A-CN BGB-24714 Participants will receive escalating doses of BGB-24714 as monotherapy in Chinese participants Phase 1b: Dose Expansion BGB-24714 BGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors. Phase 1a: Dose Escalation Part B BGB-24714 Participants will receive increasing dose levels of BGB-24714 in combination with paclitaxel Phase 1b: Dose Expansion Docetaxel BGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors.
- Primary Outcome Measures
Name Time Method 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) approximately 6 months Recommended dose based upon the MTD or MAD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available
Dose Expansion: Objective response rate (ORR) 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: Number of participants with adverse events (AEs) 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.
- Secondary Outcome Measures
Name Time Method Dose Escalation: Objective response rate (ORR) 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)
Duration of Response (DOR) 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)
Time to Maximum Plasma Concentration (Tmax) of BGB-24714 and its metabolite Up to 48 hours postdose Concentration at steady state (Cmax,ss) of BGB-24714 and its metabolite Up to 48 hours postdose Dose Expansion: Number of participants with adverse events approximately 2 Years Number of participants with AEs and SAEs
Disease Control Rate (DCR) 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)
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of BGB-24714 and its metabolite Up to 48 hours postdose Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite Up to 48 hours postdose Rough Concentration At Steady State (Ctrough,ss) of BGB-24714 and its metabolite Up to 48 hours postdose Plasma Concentrations of BGB-24714 and its metabolite approximately 2 Years Clinical Benefit Rate (CBR) approximately 2 Years CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite Up to 48 hours postdose Apparent Clearance (CL/F) of BGB-24714 Up to 48 hours postdose Apparent Volume Of Distribution (Vz/F) of BGB-24714 Up to 48 hours postdose Dose Expansion: Progression-free Survival (PFS) 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
Terminal Half-life (t1/2) of BGB-24714 and its metabolite Up to 48 hours postdose Time to Maximum Plasma Concentration at steady state (Tmax,ss) of BGB-24714 and its metabolite Up to 48 hours postdose 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 Up to 48 hours postdose
Trial Locations
- Locations (36)
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Banner Md Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Scri Florida Cancer Specialists North
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialist (Scri) Sarasota
🇺🇸Sarasota, Florida, United States
Scri Florida Cancer Specialist East
🇺🇸West Palm Beach, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
🇺🇸Pittsburgh, Pennsylvania, United States
Sanford Cancer Center
🇺🇸Sioux Falls, South Dakota, United States
Avera Cancer Institue
🇺🇸Sioux Falls, South Dakota, United States
Tennessee Oncology, Pllc Nashville
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The University of Texas Md Anderson Cancer Center (Department Gi Medical Oncology)
🇺🇸Houston, Texas, United States
Intermountain Healthcare
🇺🇸Salt Lake City, Utah, United States
Next Virginia
🇺🇸Fairfax, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Northern Beaches Hospital
🇦🇺Frenchs Forest, New South Wales, Australia
Icon Cancer Centre South Brisbane
🇦🇺South Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Seoul National University Bundang Hospital
🇰🇷BundangGu SeongnamSi, Gyeonggi-do, Korea, Republic of
National Cancer Center (Korea)
🇰🇷IlsandongGu GoyangSi, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St Vincents Hospital
🇰🇷PaldalGu SuwonSi, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷NamdongGu, Incheon Gwang'yeogsi, Korea, Republic of
Samsung Medical Center
🇰🇷GangnamGu, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷SeodaemunGu, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center
🇰🇷SongpaGu, Seoul Teugbyeolsi, Korea, Republic of
Auckland City Hospital
🇳🇿Auckland, New Zealand