Phase I
Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma
- Study HIC#:2000034852
- Last Updated:08/20/2024
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
This is a multi-center, open-label, Phase 1 study designed to evaluate the safety,
tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with
advanced adenocarcinoma.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
- Age ≥ 18 years
- Adequate renal function
- Adequate liver function
- Adequate hematological function
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
- Patients must not have clinically significant cardiac disease.
- Patients must not have known non-controlled CNS metastasis.
- Patients must not have active autoimmune disease or a documented history of autoimmune disease.
- Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
- Patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
- Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
- Patients must not be women who are pregnant or breast feeding.