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Monoclonal Antibodies

BCA101 + Pembrolizumab for Cancer

Phase 1
Recruiting
Research Sponsored by Bicara Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
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
Prior treatment with any anti-TGFβ therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing BCA101, a new drug that targets specific cancer growth proteins, in patients with advanced cancers that haven't responded to other treatments. The drug works by blocking proteins that help the cancer grow and spread.

Who is the study for?
This trial is for patients with advanced solid tumors driven by EGFR, such as certain types of anal, head and neck, lung cancers, and more. Participants must have tried some treatments already without success or been unable to tolerate them. They should be relatively healthy otherwise (performance status ≤1) and willing to undergo tumor biopsies.
What is being tested?
BCA101 is being tested alone or with Pembrolizumab in this study. BCA101 targets both EGFR and TGFβ which might work well together against tumors that are driven by EGFR. The trial will see how safe it is and how well people can handle it.
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to the targeting of EGFR like skin rash or diarrhea, as well as issues from affecting TGFβ pathways which could involve various organs but specifics aren't provided here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured and biopsied, and I agree to have two biopsies and provide previous tumor samples if available.
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I can carry out all my self-care but cannot do heavy physical work.
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My scans show at least one tumor that can be measured.
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I have CSCC and have tried or can't use anti-PD-1 therapy for advanced cancer.
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My cancer is in the head or neck area, not nasopharynx, and tests show it's likely to respond to specific treatments.
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My cancer is stage IV squamous NSCLC and has worsened after one treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have chronic HBV with active disease and am not on antiviral therapy.
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I have not been treated with anti-TGFβ therapy before.
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I've had a bad reaction to cetuximab or similar drugs before.
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I haven't taken anti-EGFR antibodies in the last 4 weeks.
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I have hepatitis C and haven't completed treatment or my viral load is high.
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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Dose Limiting Toxicities (DLTs)
Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
Secondary study objectives
AUC of BCA101 and pembrolizumab
Clinical Benefit Rate
Cmax of BCA101 and pembrolizumab
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: BCA101 MonotherapyExperimental Treatment1 Intervention
Route: IV Infusion Frequency: QW Current Dose: 1500mg
Group II: BCA101 + pembrolizumabExperimental Treatment2 Interventions
Route: IV Infusion Frequency: Q3W Dose: 200mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Head and Neck Cancers include radiation therapy, chemotherapy, targeted therapy, and immunotherapy. Radiation therapy works by damaging the DNA of cancer cells, leading to cell death. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Targeted therapies, such as EGFR inhibitors (e.g., cetuximab), block the epidermal growth factor receptor, which is often overexpressed in these cancers, thereby inhibiting cell growth and proliferation. The investigational drug BCA101 targets both EGFR and TGFβ, potentially offering a synergistic effect by not only inhibiting tumor growth but also modulating the tumor microenvironment to reduce fibrosis and immune evasion. Immunotherapy, such as pembrolizumab, enhances the body's immune response against cancer cells. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment based on the tumor's specific characteristics and the patient's overall health.
EGFR status and EGFR ligand expression influence the treatment response of head and neck cancer cell lines.

Find a Location

Who is running the clinical trial?

Bicara TherapeuticsLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,996 Previous Clinical Trials
5,180,950 Total Patients Enrolled

Media Library

BCA101 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04429542 — Phase 1
Squamous Cell Carcinoma Research Study Groups: BCA101 Monotherapy, BCA101 + pembrolizumab
Squamous Cell Carcinoma Clinical Trial 2023: BCA101 Highlights & Side Effects. Trial Name: NCT04429542 — Phase 1
BCA101 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04429542 — Phase 1
~97 spots leftby Dec 2026