Phase 1Recruiting
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors
- Sponsor
- Bicara Therapeutics (Industry)
- Enrollment
- 473 planned
- Conditions
- Head and Neck Squamous Cell Carcinoma; Squamous Cell Carcinoma of Anal Canal; Colorectal Cancer; Squamous Cell Carcinoma of the Lung; EGFR Amplification; Epithelial Ovarian Cancer; Pancreas Cancer; Cutaneous Squamous Cell Carcinoma; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
- Interventions
- BCA101; Pembrolizumab
- Ages
- adults, older adults
- Registry
- NCT04429542
Full record on ClinicalTrials.gov
From the registry
The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.
Primary outcomes
- Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
- Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
- Incidence of Dose Limiting Toxicities (DLTs)
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started