What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, particularly those involving EGFR inhibition like cetuximab, are associated with several side effects. These include severe skin reactions, hypomagnesemia, and infusion-related reactions. When combined with chemotherapy, these treatments can also lead to increased rates of sepsis and other severe adverse events. Additionally, radiation therapy, often used in conjunction with these agents, can cause mucositis, dysphagia, and late toxicities such as fibrosis and osteonecrosis.

What prior FDA approvals exist?

Cetuximab, an EGFR inhibitor, is FDA-approved for the treatment of head and neck squamous cell carcinoma (HNSCC). It is often used in combination with chemotherapy or as a monotherapy for patients who have not responded to platinum-based chemotherapy. While there are no FDA-approved treatments specifically targeting both EGFR and TGFβ for head and neck cancers, the investigational drug BCA101 aims to fill this gap by targeting both pathways, potentially offering a new therapeutic approach for patients with EGFR-driven tumors.

What other types of research exist?

Promising novel alternatives to BCA101 for head and neck cancer patients include: 1) Pembrolizumab, an anti-PD1 therapy, which has shown efficacy in recurrent or metastatic squamous cell carcinoma of the head and neck. 2) Nilotinib, a multitargeted tyrosine kinase inhibitor, which inhibits CSF1R and has demonstrated disease stabilization in various cancers. 3) Emactuzumab, a monoclonal antibody targeting CSF1R, which has shown durable responses in clinical trials. These alternatives offer different mechanisms of action and have shown potential in clinical settings.

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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.

Select...

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:

Select...

I have chronic HBV with active disease and am not on antiviral therapy.

Select...

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.

Select...

I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

~3130

0 / 12Eligibility criteria met

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.