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

ConditionsHead and Neck Squamous Cell CarcinomaSquamous Cell Carcinoma of Anal CanalColorectal CancerSquamous Cell Carcinoma of the LungEGFR AmplificationEpithelial Ovarian CancerPancreas CancerCutaneous Squamous Cell CarcinomaHead and Neck NeoplasmsCarcinoma, Squamous CellSquamous Cell Carcinoma of Head and Neck
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBicara Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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).

Expansion Cohort 3: Squamous Carcinoma of the Anal Canal (SCAC), locally advanced/unresectable or metastatic.

Disqualifiers

For Part A: Exposure to anti-EGFR antibodies within 4 weeks of the first dose of study drug.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BCA101

    Drug

    EGFR/TGFβ fusion monoclonal antibody

  • Pembrolizumab

    Drug

    anti-PD-1

Treatment groups

473 Participants
are divided into 2 treatment groups
Group A: BCA101 MonotherapyExperimental treatment 1 intervention
Group B: BCA101 + pembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs

Incidence and severity of AEs and SAEs

Time frame
24 months
2

Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs

Incidence and severity of AEs and SAEs

Time frame
24 months
3

Incidence of Dose Limiting Toxicities (DLTs)

Incidence of DLTs during the first cycle of treatment with BCA101 monotherapy or the combination of BCA101 and pembrolizumab.

Time frame
21 days

Secondary outcomes

1

Objective Response Rate

Determine objective response rate in each part of the study, per RECIST v1.1 and iRECIST

Time frame
24 months
2

Clinical Benefit Rate

Determine clinical benefit rate in each part of the study, per RECIST v1.1 and iRECIST

Time frame
24 months
3

Progression free survival

Determine PFS in each part of the study, per RECIST v1.1 and iRECIST

Time frame
24 months
4

Duration of Response

Determine duration of response in each part of the study, per RECIST v1.1 and iRECIST

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bicara Therapeutics

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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