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
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
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.
Key Eligibility Criteria :
Participants must sign a written informed consent form (ICF); and agree to comply with study requirement
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.
Participants must be able to provide formalin-fixed paraffin embedded (FFPE) tumor tissue sample.
Phase 1a Part A, A-CN, B and Phase 1b: ≥ 1 measurable lesion per Response evaluation criteria in solid tumors (RECIST) v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Houston, Texas 77030-4000, United States
IlsandongGu GoyangSi, Gyeonggi-do 10408, South Korea
NamdongGu, Incheon Gwang'yeogsi 21565, South Korea
GangnamGu, Seoul Teugbyeolsi 06351, South Korea
SeodaemunGu, Seoul Teugbyeolsi 03722, South Korea
SongpaGu, Seoul Teugbyeolsi 05505, South Korea