OncoMatch/Clinical Trials/NCT04429542
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
Is NCT04429542 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BCA101 and Pembrolizumab for head and neck squamous cell carcinoma.
Treatment: BCA101 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Ovarian Cancer
Pancreatic Cancer
Biomarker criteria
Required: PD-L1 (CD274) CPS >= 1 (CPS >= 1)
Combined Positive Score (CPS) equal to or greater than 1, as determined by an CLIA-approved laboratory test
Required: PD-L1 (CD274) CPS < 1 (CPS < 1)
Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx
Disease stage
Required: Stage IV, III (AJCC 8th edition (for SqNSCLC))
measurable disease...as defined by RECIST 1.1 and iRECIST; stage IV (AJCC 8th edition) squamous NSCLC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — metastatic or locally advanced
patients must have received (or been intolerant to or ineligible for) prior anti-PD-1 therapy in the metastatic or locally advanced setting
Must have received: chemotherapy — unresectable and/or metastatic
must have received (or been intolerant to or ineligible for) at least 1 prior line of chemotherapy
Must have received: systemic therapy — unresectable and/or metastatic
received no more than 2 prior lines of systemic treatments for treatment of unresectable and/or metastatic disease
Must have received: systemic therapy
must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens
Cannot have received: anti-EGFR antibody
Exception: prior treatment with radiotherapy in the adjuvant setting is allowed
No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed)
Cannot have received: anti-EGFR antibody
Exception: radiosensitizing agents and multimodal treatment for locally advanced disease allowed
No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease)
Cannot have received: immune checkpoint inhibitor
No prior history of immune checkpoint inhibitors
Cannot have received: anti-TGFβ therapy
Prior treatment with any anti-TGFβ therapy
Cannot have received: anti-EGFR antibody (cetuximab)
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moores Cancer Center UC San Diego Health · La Jolla, California
- Keck School of Medicine of USC · Los Angeles, California
- UCLA · Los Angeles, California
- University of California, Davis Comprehensive Cancer Center · Sacramento, California
- H. Lee Moffitt Cancer Center and Research Institute, Inc · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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