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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: Recruiting Phase 1 study of Colorectal Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Bicara Therapeutics.
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 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence and severity of AEs and SAEs
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What NCT04429542 shows while recruiting
NCT04429542 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (81% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04429542's enrollment target sits among peer trials
292 118th of 381 higher than 263 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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