RecruitingPhase 1NCT04429542

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

Enrollment

292 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma of Anal Canal

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BCA101, alone or with pembrolizumab, in people with solid tumors (cancers that form lumps, not blood cancers). BCA101 targets two signals that help tumors grow and hide from the immune system. **You may be eligible if...** - You have a solid tumor (such as head and neck, colorectal, or other cancer) that has stopped responding to standard treatment - Your tumor can be safely biopsied - You are able to carry out daily activities without much difficulty - You are 18 or older **You may NOT be eligible if...** - You have previously received anti-EGFR antibody treatment within the past 4 weeks - You have received any anti-TGF-beta therapy in the past - You have had a severe reaction to similar drugs - You have active autoimmune disease requiring treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBCA101

EGFR/TGFβ fusion monoclonal antibody

DRUGPembrolizumab

anti-PD-1

Locations(20)

Moores Cancer Center UC San Diego Health

La Jolla, California, United States

Keck School of Medicine of USC

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States

H. Lee Moffitt Cancer Center and Research Institute, Inc

Tampa, Florida, United States

Dana Farber/Partners Cancer Care Inc

Boston, Massachusetts, United States

Memorial Sloan Kettering

New York, New York, United States

Columbia University Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina, Hollings Cancer Center

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04429542

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