First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGF Fusion Protein BCA101 Alone and in Combination with Pembrolizumab in Patients with EGFR-Driven Advanced Solid Tumors
Study of Safety and Tolerability of BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-driven Advanced Solid Tumors
Sponsor: Bicara Therapeutics
Enrolling: Male and Female Patients
IRB Number: AAAT0903
U.S. Govt. ID: NCT04429542
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This is a first-in-human clinical research study. This study is sponsored by a biopharmaceutical company named Bicara Therapeutics. The main purpose of this study is to investigate the study drug BCA101 alone and BCA101 in combination with pembrolizumab for its safety, the way the body absorbs, distributes, and gets rid of this study drug, how the study drug acts on the body, and whether it works on your cancer in patients with advanced cancer like you. Subjects will receive either BCA101 alone or BCA101 in combination with pembrolizumab until disease worsens, the subject stops benefitting from the treatment, or the subject has unacceptable side effects. Cancers include: bladder cancer, breast cancer, colon cancer, rectal cancer, esophageal cancer, gynecologic cancers (cervical, ovarian, uterine), head, neck/oral cancers, kidney cancer, adrenal cancer, liver cancer, lung cancer, Hodgkin's disease, pancreatic cancer, prostate cancer, sarcoma, stomach cancer, testicular cancer, and thyroid cancer.
Investigator
Richard Carvajal, MD
Do You Qualify?
Are you at least 18 years of age? Yes No
Have you been diagnosed with advanced cancer? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162