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Clinical Trials in the USA / NCT05808634
Recruiting Phase 1

Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

NCT05808634 · tracked via the Priya Life Science USA tracker
Sponsor
BioAtla, Inc
Phase
Phase 1
Started
2023-07-14
Last updated
2025-09-25

Condition(s) studied

Advanced Adenocarcinoma

Investigational drug(s) / intervention(s)

BA3182

BA3182: Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM

Study summary

The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (9)

FacilityCityRegionStatus
UC Irvine Irvine California Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Northwestern University Chicago Illinois Recruiting
University of Illinois Chicago Illinois Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
The Christ Hospital Cancer Center Cincinnati Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Fred Hutch Cancer Center Seattle Washington Recruiting

Other trials for the same condition

A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05808634 on ClinicalTrials.gov ↗ ← All trials in the USA