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
Bicara Therapeutics
Summary
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.
Description
This is a Phase 1/1b, open-label study, which consists of dose escalation parts (Part A) followed by expansion cohorts (Part B) for both single agent BCA101 and combination BCA101 plus pembrolizumab. The study population in dose escalation (Part A) of single agent BCA101 consists of subjects with EGFR-driven advanced solid tumors refractory to standard of care or for whom no standard of care is available. Dose escalation (Part A) of combination BCA101 and pembrolizumab consists of subjects with either Squamous Cell Carcinoma of the Head and Neck (HNSCC) or Squamous Cell Carcinoma of the Anal…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must have measurable disease amendable to biopsy and be willing to undergo both a pre-treatment and on-treatment biopsy, as well as provide archival tumor if available from the primary tumor (a paraffin embedded tumor tissue block sufficient to obtain at least 10 sections of 4 to 5 micrometer thickness). * Patient must have a performance status of ≤1 on the Eastern Cooperative Oncology Group Performance Scale. * Patients must have evaluable or measurable disease (computed tomography \[CT\]/magnetic resonance imaging \[MRI\] scans performed within 21 days before t…
Interventions
- DrugBCA101
EGFR/TGFβ fusion monoclonal antibody
- DrugPembrolizumab
anti-PD-1
Locations (20)
- Moores Cancer Center UC San Diego HealthLa Jolla, California
- Keck School of Medicine of USCLos Angeles, California
- UCLALos Angeles, California
- University of California, Davis Comprehensive Cancer CenterSacramento, California
- H. Lee Moffitt Cancer Center and Research Institute, IncTampa, Florida
- Dana Farber/Partners Cancer Care IncBoston, Massachusetts