Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

An Open-label, Multicenter, Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Efficacy of BA3182, a Bispecific Epithelial Cell Adhesion Molecule (EpCAM)/CD3 Antibody, in Patients With Advanced Adenocarcinoma

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Adenocarcinoma
• Intervention / Treatment: Drug: BA3182

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.

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BioAtla Medical Affairs; Phone Number: 3333 858-558-0708; Email: medicalaffairs@bioatla.com

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • Recruiting
      • UC Irvine
      • Contact: Chao Family Comprehensive Cancer Center; Phone Number: 877-827-8839; Email: ucstudy@hs.uci.edu
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC Norris Comprehensive Cancer Center
      • Contact: Lorraine Martinez Seng; Phone Number: 323-865-3000; Email: Lorraine.Martinez@med.usc.edu
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale Cancer Center
      • Contact: Ingrid Palma; Phone Number: 203-833-1034; Email: ingrid.palma@yale.edu
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Clinical Research Office; Phone Number: 312-695-1301; Email: cancer@northwestern.edu
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois
      • Contact: Omer Qazi; Phone Number: 312-413-1069; Email: omerqazi@uic.edu
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
      • Contact: Clarice Zuccaro; Phone Number: 313-576-9375; Email: zuccaroc@karmanos.org
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital Cancer Center
      • Contact: Abby Reed; Phone Number: 513-585-0844; Email: abby.reed@thechristhospital.com
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Principal Investigator; Phone Number: 216-844-3951; Email: Madison.Conces@UHHospitals.org
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch Cancer Center
      • Contact: Phase 1 Clinical Trials; Phone Number: 206-606-7551; Email: phase1clinicaltrial@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BA3182; All Patients will receive BA3182	Drug: BA3182; Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Assess dose limiting toxicity as defined in the protocol	Phase 1 Part 1: Safety Profile of BA3182	Up to 24 months
Part 1: Assess maximum tolerated dose as defined in the protocol	Phase 1 Part 1: Safety Profile of BA3182	Up to 24 months
Part 2: Confirmed overall response rate (ORR) per RECIST v1.1	Phase 1 Part 2: Antitumor activity of BA3182	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed overall response rate (ORR) per RECIST v1.1	Phase 1 Part 1: Antitumor activity of BA3182	Up to 24 months
Confirmed best overall response best overall response (BOR)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Confirmed duration of response (DOR)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Confirmed progression-free survival (PFS)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Confirmed disease control rate (DCR)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Confirmed time to response (TTR)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Confirmed overall survival (OS)	Phase 1: Antitumor activity of BA3182	Up to 24 months
Confirmed percent change from baseline in target lesion sum of diameters.	Phase 1: Antitumor activity of BA3182	Up to 24 months
Area under the plasma concentration versus time curve (AUC)	Phase 1: Pharmacokinetics of BA3182	Up to 24 months
Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics	Phase 1: Pharmacokinetics of BA3182	Up to 24 months
Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity	Phase 1: Immunogenicity of BA3182	Up to 24 months
Incidence of neutralizing antibodies (nAbs) to BA3182.	Phase 1: Immunogenicity of BA3182	Up to 24 months

Collaborators and Investigators

• Sponsor: BioAtla, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 15, 2028

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Advanced; Metastatic
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: BA3182-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No