Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
NCT ID: NCT04429542
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
292 participants
INTERVENTIONAL
2020-06-01
2027-06-01
Brief Summary
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Detailed Description
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The study population in dose escalation (Part A) of single agent BCA101 consists of subjects with EGFR-driven advanced solid tumors refractory to standard of care or for whom no standard of care is available. Dose escalation (Part A) of combination BCA101 and pembrolizumab consists of subjects with either Squamous Cell Carcinoma of the Head and Neck (HNSCC) or Squamous Cell Carcinoma of the Anal Canal (SCCAC) whose tumors are refractory to standard of care or for whom no standard of care is available.
Once the maximum tolerated dose (MTD) / recommended dose (RD) of single agent BCA101 is determined, the study will continue with expansion cohorts (Part B) with select tumor types. Expansion cohorts for single agent BCA101 will include cutaneous squamous cell carcinoma. Planned expansion cohorts for the combination of BCA101 and pembrolizumab include: 1) HNSCC and 2) SCCAC.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BCA101 Monotherapy
Route: IV Infusion Frequency: QW Current Dose: 1500mg
BCA101
EGFR/TGFβ fusion monoclonal antibody
BCA101 + pembrolizumab
Route: IV Infusion Frequency: Q3W Dose: 200mg
BCA101
EGFR/TGFβ fusion monoclonal antibody
Pembrolizumab
anti-PD-1
Interventions
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BCA101
EGFR/TGFβ fusion monoclonal antibody
Pembrolizumab
anti-PD-1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
PART B (Cohort expansion):
1. Single agent BCA101 - patients with the following tumor type will be eligible:
• Expansion Cohort 1: Cutaneous Squamous Cell Carcinoma (CSCC) - i. patients must have received (or been intolerant to or ineligible for) prior anti-PD-1 therapy in the metastatic or locally advanced setting.
ii. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).
2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:
• Expansion Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) equal to or greater than 1, as determined by an CLIA-approved laboratory test. Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).
i. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed \>6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (\>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).
ii. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.
iii. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
* Expansion Cohort 3: Squamous Carcinoma of the Anal Canal (SCAC), locally advanced/unresectable or metastatic.
i. Patients must have received (or been intolerant to or ineligible for) at least 1 prior line of chemotherapy and received no more than 2 prior lines of systemic treatments for treatment of unresectable and/or metastatic disease. No prior history of immune checkpoint inhibitors.
* 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.
ii. Patients must have progressed on one prior systemic therapy in the metastatic setting.
iii. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.
• Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.
3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab • Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Bicara Therapeutics
INDUSTRY
Responsible Party
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Locations
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Moores Cancer Center UC San Diego Health
La Jolla, California, United States
Keck School of Medicine of USC
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States
Dana Farber/Partners Cancer Care Inc
Boston, Massachusetts, United States
Memorial Sloan Kettering
New York, New York, United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Andrew Birkeland, MD
Role: primary
DFCI Clinical Trials Hotline
Role: primary
Role: primary
Daniel R Carrizosa, MD, MS, FACP
Role: primary
Role: primary
Jenny Lee, MBBS, FRACP
Role: primary
Role: primary
Alesha Thai, MBBS, FRACP, PhD
Role: primary
Role: primary
Role: primary
Other Identifiers
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KEYNOTE-E28
Identifier Type: OTHER
Identifier Source: secondary_id
BCA101X1101
Identifier Type: -
Identifier Source: org_study_id
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