NCT04429542

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Bicara Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 Canal (SCCAC) whose tumors are refractory to standard of care or for whom no standard of care is available. Once the maximum tolerated dose (MTD) / recommended dose (RD) of single agent BCA101 is determined, the study will continue with expansion cohorts (Part B) with select tumor types. Expansion cohorts for single agent BCA101 will include cutaneous squamous cell carcinoma. Planned expansion cohorts for the combination of BCA101 and pembrolizumab include: 1) HNSCC and 2) SCCAC.

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

Type	Name	Description
DRUG	BCA101	EGFR/TGFβ fusion monoclonal antibody
DRUG	Pembrolizumab	anti-PD-1

Timeline

• Start date: 2020-06-01
• Primary completion: 2026-12-31
• Completion: 2027-06-01
• First posted: 2020-06-12
• Last updated: 2025-08-15

Locations

20 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study