> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-bgb-24714-as-monotherapy-and-with-combination-b2897bac-2515-4b7c-a48f-8dbd0a228894 > Record changed: 2026-10-13 # A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors NCT05381909 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) Participants 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) Lead sponsor BeiGene Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) Start date 2022-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) Number of sites 34 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Short title** A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **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 With Combination Therapies in Patients With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Reason 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Dates **Completion date** 2025-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **First posted** 2022-05-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Registry last updated** 2026-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Primary completion date** 2025-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Start date** 2022-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Size and sites **Actual participants** 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Participants** 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Number of sites** 34 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Lead sponsor** BeiGene Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Identifiers **Registry ID** NCT05381909 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **ClinicalTrials.gov ID** NCT05381909 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Outcomes ### Primary outcomes 1. Dose Escalation: Number of participants with adverse events (AEs) Timeframe: 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. 2. Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT) Timeframe: approximately 6 months 3. Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT) Timeframe: 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 4. Dose Expansion: Objective response rate (ORR) Timeframe: 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) ### Secondary outcomes 1. Dose Escalation: Objective response rate (ORR) Timeframe: 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) 2. Dose Expansion: Progression-free Survival (PFS) Timeframe: 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 3. Dose Expansion: Number of participants with adverse events Timeframe: approximately 2 Years Number of participants with AEs and SAEs 4. Duration of Response (DOR) Timeframe: 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) 5. Disease Control Rate (DCR) Timeframe: 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) 6. Clinical Benefit Rate (CBR) Timeframe: 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) 7. Plasma Concentrations of BGB-24714 and its metabolite Timeframe: approximately 2 Years 8. Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite Timeframe: Up to 48 hours postdose 9. Time to Maximum Plasma Concentration (Tmax) of BGB-24714 and its metabolite Timeframe: Up to 48 hours postdose 10. Terminal Half-life (t1/2) of BGB-24714 and its metabolite Timeframe: Up to 48 hours postdose 11. Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of BGB-24714 and its metabolite Timeframe: Up to 48 hours postdose 12. Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite Timeframe: Up to 48 hours postdose 13. Apparent Clearance (CL/F) of BGB-24714 Timeframe: Up to 48 hours postdose 14. Apparent Volume Of Distribution (Vz/F) of BGB-24714 Timeframe: Up to 48 hours postdose 15. Concentration at steady state (Cmax,ss) of BGB-24714 and its metabolite Timeframe: Up to 48 hours postdose 16. Time to Maximum Plasma Concentration at steady state (Tmax,ss) of BGB-24714 and its metabolite Timeframe: Up to 48 hours postdose 17. 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 Timeframe: Up to 48 hours postdose 18. Rough Concentration At Steady State (Ctrough,ss) of BGB-24714 and its metabolite Timeframe: Up to 48 hours postdose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Sites - Banner Md Anderson Cancer CenterGilbert, United States - Florida Cancer Specialist (Scri) SarasotaSarasota, United States - Scri Florida Cancer Specialists NorthSt. Petersburg, United States - Scri Florida Cancer Specialist EastWest Palm Beach, United States - Massachusetts General HospitalBoston, United States - Barbara Ann Karmanos Cancer InstituteDetroit, United States - Hackensack University Medical CenterHackensack, United States - Upmc Hillman Cancer Center(Univ of Pittsburgh)Pittsburgh, United States - Sanford Cancer CenterSioux Falls, United States - Avera Cancer InstituteSioux Falls, United States - Tennessee Oncology, Pllc NashvilleNashville, United States - Mary Crowley Cancer ResearchDallas, United States - University of Texas Southwestern Medical CenterDallas, United States - The University of Texas Md Anderson Cancer Center (Department Gi Medical Oncology)Houston, United States - Intermountain HealthcareSalt Lake City, United States - Next VirginiaFairfax, United States - University of WashingtonSeattle, United States - Northern Beaches HospitalFrenchs Forest, Australia - Icon Cancer Centre South BrisbaneSouth Brisbane, Australia - Princess Alexandra HospitalWoolloongabba, Australia - Austin HealthHeidelberg, Australia - Peter Maccallum Cancer CentreMelbourne, Australia - Sunshine HospitalSt Albans, Australia - Chongqing Cancer HospitalChongqing, China - Henan Cancer HospitalZhengzhou, China And 9 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## References ### Other registry identifiers - CTR20232532 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05381909) ## Related records ### Drugs (3) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) ### Lead sponsors (1) - [BeiGene](https://trialight.com/data/company/beigene-24d4d1a6-a3a7-4bba-abf1-5afd925f742d.md) ### Conditions (1) - [ADULT syndrome](https://trialight.com/data/condition/adult-syndrome-8aeb5e11-f165-5276-850c-05129a3e72a5.md) Primary condition ### Targets (15) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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