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NCT04429542 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Colorectal Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Bicara Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
292
Enrollment target
20
Study locations

NCT04429542 is a Phase 1 study of Colorectal Cancer and Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Bicara Therapeutics. The registered enrollment target is 292 participants, below the 1,510-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT04429542, a Phase 1 study of Colorectal Cancer and Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Bicara Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
292 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Colorectal Cancer Head and Neck Squamous Cell Carcinoma Pancreas Cancer Epithelial Ovarian Cancer Head and Neck Neoplasms Cutaneous Squamous Cell Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of the Lung Squamous Cell Carcinoma of Anal Canal EGFR Amplification

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, categorized as Phase 1. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,510-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (81% lower). The listed sponsor is Bicara Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT04429542 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, New South Wales.

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.

What interventions are being tested in trial NCT04429542?

The interventions under investigation include: Pembrolizumab (DRUG), BCA101 (DRUG).

Who is sponsoring clinical trial NCT04429542?

This trial is sponsored by Bicara Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.