Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
completion around
Principal Investigator
by Deborah Wong (ucla)

Description

Summary

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.

Official Title

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

Details

This is a Phase 1/1b, open-label study, which consists of dose escalation parts (Part A) followed by expansion cohorts (Part B) for both single agent BCA101 and combination BCA101 plus pembrolizumab.

The study population in dose escalation (Part A) of single agent BCA101 consists of subjects with EGFR-driven advanced solid tumors refractory to standard of care or for whom no standard of care is available. Dose escalation (Part A) of combination BCA101 and pembrolizumab consists of subjects with either Squamous Cell Carcinoma of the Head and Neck (HNSCC) or Squamous Cell Carcinoma of the Anal Canal (SCCAC) whose tumors are refractory to standard of care or for whom no standard of care is available.

Once the maximum tolerated dose (MTD) / recommended dose (RD) of single agent BCA101 is determined, the study will continue with expansion cohorts (Part B) with select tumor types. Expansion cohorts for single agent BCA101 will include cutaneous squamous cell carcinoma. Planned expansion cohorts for the combination of BCA101 and pembrolizumab include: 1) HNSCC and 2) SCCAC.

Keywords

Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal, Colorectal Cancer, Squamous Cell Carcinoma of the Lung, EGFR Amplification, Epithelial Ovarian Cancer, Pancreas Cancer, Cutaneous Squamous Cell Carcinoma, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, TGFβ, EGFR, pembrolizumab, ficerafusp alfa, Carcinoma, Squamous Cell Carcinoma, Ovarian Epithelial Carcinoma, Pancreatic Neoplasms, Lung Neoplasms, BCA101, BCA101 Monotherapy, BCA101 + pembrolizumab

Eligibility

Locations

  • Moores Cancer Center UC San Diego Health accepting new patients
    La Jolla California 92093 United States
  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • Keck School of Medicine of USC accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Deborah Wong (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 30 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bicara Therapeutics
ID
NCT04429542
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 292 study participants
Last Updated