CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 292 target
Drug / intervention
BCA101 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 16
  • ✓Measurable disease amenable to biopsy with willingness to undergo pre-treatment and on-treatment biopsies
  • ✓ECOG performance status ≤1
  • ✓Evaluable or measurable disease on CT/MRI within 21 days before screening visit
  • ✓At least 1 unidimensional measurable lesion by RECIST 1.1 and iRECIST
Key exclusion· 15
  • ✕Part A: Anti-EGFR antibodies within 4 weeks of first dose
  • ✕Prior anti-TGFβ therapy
  • ✕Grade ≥2 intolerance/hypersensitivity to cetuximab or anti-EGFR therapy or prior discontinuation due to toxicity
  • ✕Pregnant or breastfeeding women

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04429542
NCT04429542Phase 1RecruitingHigh MomentumUpdated 10mo ago
Long Recruiting
CompareCT.gov

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·interventional·Posted Jun 12, 2020·Updated Aug 15, 2025

In Brief

A Phase 1 clinical trial evaluating BCA101 and Pembrolizumab for Head and Neck Squamous Cell Carcinoma and 10 related conditions. Currently recruiting, targeting 292 participants across 20 sites in 3 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead 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
CountriesAustralia, Canada, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1Recruiting
2021202220232024202520262027
First PostedJun 12, 2020
Enrollment StartJun 1, 2020
Primary CompletionDec 31, 2026
Study CompletionJun 1, 2027
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 6.1 years agoPrimary completion in 6 months

Interventions

BCA101drug

EGFR/TGFβ fusion monoclonal antibody

Pembrolizumabdrug

anti-PD-1