BA3071-001
A Phase 1/2 Study Of BA3071 As Monotherapy And In Combination With A PD-1 Blocking Antibody In Patients With Advanced Solid Tumors
Trial summary:
A Phase 1/2 Study Of BA3071 As Monotherapy And In Combination With A PD-1 Blocking Antibody In Patients With Advanced Solid Tumors
Receptor status / problem studied:
Advanced Solid Tumors
Inclusion criteria
- Patients must have measurable disease.
- Age ≥ 18 years
- CLTA-4 blocking-antibody naïve
- Adequate renal function
- Adequate liver function
- Adequate hematological function
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS <1%
- Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only)
Exclusion criteria
- Patients must not have clinically significant cardiac disease.
- Patients must not have known non-controlled CNS metastasis.
- Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
- Patients must not have had major surgery within 4 weeks before first BA3071 administration.
- Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
- Patients must not be women who are pregnant or breast feeding.
Open for recruitment
Trial Title
BA3071-001
Diagnosis
Advanced solid tumours
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
I/II
Locations
Investigators
Principal Investigator