NCT05808634PHASE1Recruiting
Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
BioAtla, Inc.
Start Date
7/14/2023
Completion Date
9/15/2028
Summary
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
Detailed 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
Age Range: 18 years to No maximum
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.
Interventions
DRUG
BA3182
Conditions
Advanced Adenocarcinoma
Locations
UC Irvine
Irvine, California 92697
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Yale Cancer Center
New Haven, Connecticut 06511
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
The Christ Hospital Cancer Center
Cincinnati, Ohio 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Fred Hutch Cancer Center
Seattle, Washington 98109
United States