BGB-24714-101
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
Trial summary:
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
Receptor status / problem studied:
Inclusion criteria
1) Participants must sign a written informed consent form (ICF); and agree to comply with study requirement.
2) Phase 1a (Dose Escalation):
|— a) 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 participants in mainland China will be eligible for Part A-CN.
|— b) Part C: Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III NSCLC suitable for definitive CRT.
|— c) Part D: Participant with locally advanced, histologically confirmed ESCC suitable for definitive CRT.
3) Participants 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 for Part A, A-CN and B.
4) Part A, A-CN, B: ≥ 1 measurable lesion per RECIST v1.1.
5) ECOG Performance Status ≤ 1.
6) Participants with adequate organ function.
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) Any major surgical procedure ≤ 28 days before the first dose of study drug(s).
6) Prior exposure to agents with Smac mimetics, or other IAP antagonists.
Trial Title
BGB-24714-101
Diagnosis
Advanced solid tumours
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
I