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Study of BCA101 for Advanced Solid Tumors

This study is testing a new drug called BCA101, alone and in combination with pembrolizumab, for people with advanced solid tumors driven by EGFR (a protein that can make cancer grow). BCA101 is designed to target both EGFR and TGFβ, which may work together to fight these cancers. The main goal is to see how safe BCA101 is and how well people tolerate it. Researchers will also look at how many people experience severe side effects. You may be able to join if you have certain advanced solid tumors, such as head and neck squamous cell carcinoma, colorectal cancer, or lung squamous cell carcinoma, and are at least 18 years old. You will need to have a tumor that can be measured and agree to biopsies.

Study design
This is a Phase 1/1b, open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 292 participants.
What's involved
You will need to undergo a biopsy before treatment and another during treatment. You will also need to provide existing tumor tissue if available.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be monitored for 24 months after treatment.

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NCT04429542

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bicara Therapeutics
~292 participants
Updated 2025-08-15 on ClinicalTrials.gov
What's tested:BCA101Pembrolizumab

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
Measured over 24 months
+2 more outcomes measured

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

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Anal Canal Squamous Cell CarcinomaColorectal CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaSkin Squamous Cell CarcinomaSolid NeoplasmSoluble Epidermal Growth Factor Receptor

Where it's being run

20 sites across 14 states
California4
New York2
New South Wales2
Victoria2
Florida1
Massachusetts1
North Carolina1
Ohio1

Who to contact

David Bohr
[email protected]
6178000335
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient must have measurable disease amendable to biopsy and be willing to undergo both a pre-treatment and on-treatment biopsy, as well as provide archival tumor if available from the primary tumor (a paraffin embedded tumor tissue block sufficient to obtain at least 10 sections of 4 to 5 micrometer thickness).
Patient must have a performance status of ≤1 on the Eastern Cooperative Oncology Group Performance Scale.
Patients must have evaluable or measurable disease (computed tomography \[CT\]/magnetic resonance imaging \[MRI\] scans performed within 21 days before the screening visit are acceptable) demonstrating measurable disease, i.e., at least 1 unidimensional measurable lesion as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Tumor eligibility:
Expansion Cohort 3: Squamous Carcinoma of the Anal Canal (SCAC), locally advanced/unresectable or metastatic.
Expansion Cohort 5: Squamous Non-Small Cell Lung Cancer (SqNSCLC) i. Patients must have a histologically or cytologically confirmed diagnosis of stage IV (AJCC 8th edition) squamous NSCLC. Patients with mixed histology (e.g., adenosquamous) are not allowed.

Exclusion

For Part A: Exposure to anti-EGFR antibodies within 4 weeks of the first dose of study drug.
Prior treatment with any anti-TGFβ therapy.
Prior history of Grade ≥ 2 intolerance or hypersensitivity reaction to cetuximab or other anti-EGFR therapy or other murine proteins or prior discontinuation of therapy in the setting of toxicity related to treatment.
Pregnant or breastfeeding women.
Any condition requiring systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study drug, with the exception of topical, intranasal, intrabronchial, or ocular steroids.
Known history of a hematologic malignancy (or solid tumor other than the ones indicated for this study), unless the patient has undergone potentially curative therapy with no evidence of that disease for 2 years. Does not include tumors with a negligible risk of metastasis or death (e.g. adequately treated basal or squamous cell carcinoma, stage 1 prostate cancer, or carcinoma in situ of the cervix or carcinoma in situ of the breast). Subjects enrolling in the CSCC cohort may have chronic lymphocytic leukemia as long as the patient is not on active treatment.
Known cases of human immunodeficiency virus (HIV) are excluded if patients have a CD4+ T-cell (CD4+) count \<250 cells/uL. To ensure that effective antiretroviral therapy (ART) is tolerated and that toxicities are not confused with investigational drug toxicities, trial participants should be on established ART for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
Patients with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment
Patients with a known history of hepatitis C who have not completed curative antiviral treatment or have a HCV viral load above the limit of quantification

What this trial measures

  • Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs24 months

    Incidence and severity of AEs and SAEs

  • Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs24 months

    Incidence and severity of AEs and SAEs

  • Incidence of Dose Limiting Toxicities (DLTs)21 days

    Incidence of DLTs during the first cycle of treatment with BCA101 monotherapy or the combination of BCA101 and pembrolizumab.