Actively Recruiting
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
Led by Bicara Therapeutics · Updated on 2025-08-15
292
Participants Needed
20
Research Sites
365 weeks
Total Duration
On this page
Sponsors
B
Bicara Therapeutics
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must have measurable disease that can be biopsied and be willing to provide tumor samples for analysis.
- Patient must have an Eastern Cooperative Oncology Group performance status of 1 or less.
- Patients must have evaluable or measurable disease confirmed by CT or MRI scans within 21 days before screening.
- For single agent BCA101 expansion: Patients with cutaneous squamous cell carcinoma who have received or are intolerant or ineligible for prior anti-PD-1 therapy, and no prior anti-EGFR antibody treatment in metastatic or unresectable disease.
- For combination BCA101 and pembrolizumab expansion: Patients with metastatic or unresectable head and neck squamous cell carcinoma with a Combined Positive Score of 1 or more, no prior systemic therapy in recurrent/metastatic setting (with exceptions), and required tissue samples for biomarker analysis.
- Patients with squamous carcinoma of the anal canal who have had 1 to 2 prior chemotherapy treatments and no prior immune checkpoint inhibitors.
- Patients with squamous non-small cell lung cancer stage IV who progressed on one prior systemic therapy and no prior anti-EGFR antibody treatment in metastatic setting.
- Patients with colorectal cancer who have received 2 to 3 prior systemic therapies including two standard regimens.
You will not qualify if you...
- Exposure to anti-EGFR antibodies within 4 weeks before first dose.
- Prior treatment with any anti-TGFb2 therapy.
- History of grade 2 or higher intolerance or hypersensitivity to cetuximab or anti-EGFR therapy.
- Pregnant or breastfeeding women.
- Need for systemic corticosteroids above 10 mg prednisone daily or other immunosuppressive drugs within 14 days before first dose, except topical or localized steroids.
- History of hematologic malignancy or other solid tumors unless disease-free for 2 years, excluding certain low-risk tumors.
- HIV infection with CD4 count below 250 cells/uL or not on stable antiretroviral therapy with low viral load.
- Active chronic hepatitis B infection not on suppressive antiviral therapy.
- History of hepatitis C without completed curative treatment or with detectable viral load.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Moores Cancer Center UC San Diego Health
La Jolla, California, United States, 92093
Actively Recruiting
2
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
Actively Recruiting
3
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
4
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
5
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States, 33612
Actively Recruiting
6
Dana Farber/Partners Cancer Care Inc
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Memorial Sloan Kettering
New York, New York, United States, 10017
Actively Recruiting
8
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
9
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
10
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
11
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
13
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
14
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
17
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
18
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
19
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
20
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
D
David Bohr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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