Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
- Registration Number
- NCT05808634
- Lead Sponsor
- BioAtla, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 168
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BA3182 BA3182 All Patients will receive BA3182
- Primary Outcome Measures
Name Time Method Part 1: Assess dose limiting toxicity as defined in the protocol Up to 24 months Phase 1 Part 1: Safety Profile of BA3182
Part 1: Assess maximum tolerated dose as defined in the protocol Up to 24 months Phase 1 Part 1: Safety Profile of BA3182
Part 2: Confirmed overall response rate (ORR) per RECIST v1.1 Up to 24 months Phase 1 Part 2: Antitumor activity of BA3182
- Secondary Outcome Measures
Name Time Method Confirmed overall response rate (ORR) per RECIST v1.1 Up to 24 months Phase 1 Part 1: Antitumor activity of BA3182
Confirmed best overall response best overall response (BOR) Up to 24 months Phase 1: Antitumor activity of BA3182
Confirmed duration of response (DOR) Up to 24 months Phase 1: Antitumor activity of BA3182
Confirmed progression-free survival (PFS) Up to 24 months Phase 1: Antitumor activity of BA3182
Confirmed disease control rate (DCR) Up to 24 months Phase 1: Antitumor activity of BA3182
Confirmed time to response (TTR) Up to 24 months Phase 1: Antitumor activity of BA3182
Confirmed overall survival (OS) Up to 24 months Phase 1: Antitumor activity of BA3182
Confirmed percent change from baseline in target lesion sum of diameters. Up to 24 months Phase 1: Antitumor activity of BA3182
Area under the plasma concentration versus time curve (AUC) Up to 24 months Phase 1: Pharmacokinetics of BA3182
Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics Up to 24 months Phase 1: Pharmacokinetics of BA3182
Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity Up to 24 months Phase 1: Immunogenicity of BA3182
Incidence of neutralizing antibodies (nAbs) to BA3182. Up to 24 months Phase 1: Immunogenicity of BA3182
Trial Locations
- Locations (5)
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
The Christ Hospital Cancer Center
🇺🇸Cincinnati, Ohio, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States