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RECRUITING Phase 1

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

NCT04429542 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Pembrolizumab
  • DRUG BCA101

Study Locations (20)

California

  • Moores Cancer Center UC San Diego Health — La Jolla
  • Keck School of Medicine of USC — Los Angeles
  • UCLA — Los Angeles
  • University of California, Davis Comprehensive Cancer Center — Sacramento

New York

  • Memorial Sloan Kettering — New York
  • Columbia University Herbert Irving Comprehensive Cancer Center — New York

New South Wales

  • Chris O'Brien Lifehouse — Camperdown
  • Calvary Mater Newcastle — Waratah

Victoria

  • Austin Hospital — Heidelberg
  • Peter MacCallum Cancer Centre — Melbourne

Florida

  • H. Lee Moffitt Cancer Center and Research Institute, Inc — Tampa

Massachusetts

  • Dana Farber/Partners Cancer Care Inc — Boston

North Carolina

  • Levine Cancer Institute — Charlotte

Ohio

  • Cleveland Clinic — Cleveland

Trial Details

FieldValue
Enrollment Target 292 participants
Start Date 2020-06-01
Est. Completion 2027-06-01
Phase Phase 1

Sponsor

Bicara Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04429542

The ClinicalTrials.gov registry entry for NCT04429542 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bicara Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04429542 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, New York, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04429542 about?

NCT04429542 is a clinical study titled "Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors". 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.

What is the current status of trial NCT04429542?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 292 participants. The study started on 2020-06-01. Estimated completion is 2027-06-01.

What conditions does trial NCT04429542 study?

This clinical trial studies the following conditions: Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Pancreas Cancer, Epithelial Ovarian Cancer, Head and Neck Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04429542?

The interventions under investigation include: Pembrolizumab (DRUG), BCA101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04429542?

This trial is sponsored by Bicara Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04429542 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial