Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
Public ClinicalTrials.gov record NCT04429542. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04429542
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 292 participants
Conditions and interventions
Conditions
- Head and Neck Squamous Cell Carcinoma
- Squamous Cell Carcinoma of Anal Canal
- Colorectal Cancer
- Squamous Cell Carcinoma of the Lung
- EGFR Amplification
- Epithelial Ovarian Cancer
- Pancreas Cancer
- Cutaneous Squamous Cell Carcinoma
- Head and Neck Neoplasms
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2020
- Primary completion
- Dec 30, 2026
- Completion
- May 31, 2027
- Last update posted
- Aug 14, 2025
2020 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Moores Cancer Center UC San Diego Health | La Jolla | California | 92093 | Recruiting |
| Keck School of Medicine of USC | Los Angeles | California | 90033 | Recruiting |
| UCLA | Los Angeles | California | 90095 | Recruiting |
| University of California, Davis Comprehensive Cancer Center | Sacramento | California | 95817 | Recruiting |
| H. Lee Moffitt Cancer Center and Research Institute, Inc | Tampa | Florida | 33612 | Recruiting |
| Dana Farber/Partners Cancer Care Inc | Boston | Massachusetts | 02115 | Recruiting |
| Memorial Sloan Kettering | New York | New York | 10017 | Recruiting |
| Columbia University Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| Medical University of South Carolina, Hollings Cancer Center | Charleston | South Carolina | 29425 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04429542, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 14, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04429542 live on ClinicalTrials.gov.