๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-14

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors (NCT04429542)

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFฮฒ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Bicara Therapeutics

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFฮฒ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Who can join: Review the eligibility criteria below.

Location: Moores Cancer Center UC San Diego Health โ€” La Jolla, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (20 Sites)

  • Moores Cancer Center UC San Diego Health โ€” La Jolla, California
  • Keck School of Medicine of USC โ€” Los Angeles, California
  • UCLA โ€” Los Angeles, California
  • University of California, Davis Comprehensive Cancer Center โ€” Sacramento, California
  • H. Lee Moffitt Cancer Center and Research Institute, Inc โ€” Tampa, Florida
  • Dana Farber/Partners Cancer Care Inc โ€” Boston, Massachusetts
  • Memorial Sloan Kettering โ€” New York, New York
  • Columbia University Herbert Irving Comprehensive Cancer Center โ€” New York, New York
  • Levine Cancer Institute โ€” Charlotte, North Carolina
  • Cleveland Clinic โ€” Cleveland, Ohio
  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania
  • Rhode Island Hospital โ€” Providence, Rhode Island
  • Medical University of South Carolina, Hollings Cancer Center โ€” Charleston, South Carolina
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • MD Anderson Cancer Center โ€” Houston, Texas
  • Chris O'Brien Lifehouse โ€” Camperdown, New South Wales
  • Calvary Mater Newcastle โ€” Waratah, New South Wales
  • Austin Hospital โ€” Heidelberg, Victoria
  • Peter MacCallum Cancer Centre โ€” Melbourne, Victoria
  • Princess Margaret Cancer Centre โ€” Toronto, Ontario

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 800-0335

Email: info@bicara.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—