Recruiting
Phase 1

BA3182

Sponsor:

BioAtla, Inc.

Code:

NCT05808634

Conditions

Advanced Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BA3182

Study Details

Brief summary:

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

Conditions

Advanced Adenocarcinoma

Study ID

NCT05808634

Start date

Jul 14, 2023

Status verified date

Sep, 2025

Completion date

Sep 15, 2028

Anticipated

Primary completion date

Sep 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

168 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BA3182

All Patients will receive BA3182

Interventions

BA3182

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

Primary outcome measure

  • Part 1: Assess dose limiting toxicity as defined in the protocol [ Time Frame: Up to 24 months ]
  • Part 1: Assess maximum tolerated dose as defined in the protocol [ Time Frame: Up to 24 months ]
  • Part 2: Confirmed overall response rate (ORR) per RECIST v1.1 [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Locations

UC Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Chao Family Comprehensive Cancer Center

877-827-8839ucstudy@hs.uci.edu

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Clinical Research Office

312-695-1301cancer@northwestern.edu

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

The Christ Hospital Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Fred Hutch Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

More Information

Sponsor

BioAtla, Inc.

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Keywords

  • Advanced
  • Metastatic
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BioAtla, Inc. on 2025-09-25.