Health Trials

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

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

Treatments tested in this trial

  • BCA101
  • Pembrolizumab

Treatment groups

292 Participants
are divided into 2 treatment groups

Locations

20
Australia
Chris O'Brien Lifehouse2050, CamperdownNew South Wales, Australia
Calvary Mater Newcastle2298, WaratahNew South Wales, Australia
Austin Hospital3084, HeidelbergVictoria, Australia
Peter MacCallum Cancer Centre3000, MelbourneVictoria, Australia

Sponsors and collaborators

Bicara Therapeutics

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov