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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will test whether the investigational drug BCA101 can help treat patients with EGFR-driven tumors.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

AUC of BCA101 and pembrolizumab

Clinical Benefit Rate

Cmax of BCA101 and pembrolizumab

+8 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bicara TherapeuticsLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,854 Total Patients Enrolled

Media Library

BCA101 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04429542 — Phase 1

Head and Neck Cancers Research Study Groups: BCA101 Monotherapy, BCA101 + pembrolizumab

Head and Neck Cancers 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in the current research?

"This clinical trial requires 292 individuals who meet the inclusion criteria. Potential participants can join from both UCLA in Los Angeles, CA and H. Lee Moffitt Cancer Center & Research Institute Inc. in Tampa, FL."

Answered by AI

How many locations have enrolled in this experimental endeavor?

"Patients have 11 sites to choose from when considering enrolling in the trial, including major cities like Los Angeles and Tampa. It might be beneficial for prospective participants to select a nearby site, so as not to overburden themselves with travel costs or time commitments."

Answered by AI

Has BCA101 received the necessary approvals to be used in medical settings?

"Due to the initial stages of this medical trial, BCA101 is assigned a score of 1 for safety as there is minimal data confirming its efficacy and protecting patient wellbeing."

Answered by AI

What are the key aims of this research endeavor?

"This clinical trial will primarily gauge the tolerance of BCA101 and its combination with pembrolizumab by measuring adverse effects over 21 days. Other objectives include ascertaining immunogenicity, objective response rate, and progression free survival as outlined in RECIST v1.1 and iRECIST criteria."

Answered by AI

What medicinal purposes does BCA101 typically serve?

"BCA101 is a traditional remedy for malignant neoplasms, and can be prescribed to help patients with advanced melanoma, microsatellite instability high cases, or those suffering disease progression after chemotherapy."

Answered by AI

Is this medical research endeavor currently seeking volunteers?

"Affirmative, the information on clinicaltrials.gov demonstrates that this experiment is recruiting at present. Initially posted on June 1st 2020, it was most recently revised on September 28th 2022 and seeks to enroll 292 patients from 11 different sites."

Answered by AI

Are there any other investigations which have used BCA101 as a subject?

"The first study conducted on BCA101 was carried out in 2010 by the City of Hope. Since then, there have been 251 completed trials and 961 active studies - a significant portion of them situated in Los Angeles."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04429542.

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