First-in-Human, Phase 1/1b, Open-label, Multicenter Study ofBifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapyand in Combination Therapy in Patients with EGFR-DrivenAdvanced Solid Tumors
Contact:
NCT Number:
Protocol:
AAAT0903
Study Status:
Active/Enrolling
Population:
Adult
Phase:
I
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, BCA101 in combination with pembrolizumab, or BCA101 in combintaion with encorafenib 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, BCA101 in combination with pembrolizumab, or BCA101 in combination with encorafenib until disease worsens, the subject stops benefitting from the treatment, or the subject has unacceptable side effects.
Are you Eligible? (Inclusion Criteria)
- 18 years of age or older
- solid tumor for which no standard therapy exists or is ineligible or has declined standard therapy
- Adequate organ function
- no prior treatment with any anti-TGFβ therapy
Specialty Area(s)
Breast Cancer, Colon and Rectal Cancer, Esophageal Cancer, Gynecologic Cancers, Cervical Cancer, Ovarian Cancer, Uterine (Endometrial) Cancer, Head and Neck/Oral Cancers, Kidney Cancer/Adrenal Cancer, Liver Cancer, Lung cancer, Hodgkin's Disease, Skin cancers, Melanoma, Pancreatic Cancer, Prostate Cancer, Sarcomas (Bone and Soft Tissue), Stomach Cancer, Testicular Cancer, Thyroid Cancer, Immunotherapy
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032
