Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

NCT ID: NCT05808634

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-14

Study Completion Date

2028-09-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Advanced Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BA3182

All Patients will receive BA3182

Group Type EXPERIMENTAL

BA3182

Intervention Type DRUG

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

Interventions

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BA3182

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioAtla, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UC Irvine

Irvine, California, United States

Site Status RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Fred Hutch Cancer Center

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BioAtla Medical Affairs

Role: CONTACT

858-558-0708 ext. 3333

Facility Contacts

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Chao Family Comprehensive Cancer Center

Role: primary

877-827-8839

Lorraine Martinez Seng

Role: primary

323-865-3000

Ingrid Palma

Role: primary

203-833-1034

Clinical Research Office

Role: primary

312-695-1301

Omer Qazi

Role: primary

312-413-1069

Clarice Zuccaro

Role: primary

313-576-9375

Abby Reed

Role: primary

513-585-0844

Principal Investigator

Role: primary

216-844-3951

Phase 1 Clinical Trials

Role: primary

206-606-7551

Other Identifiers

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BA3182-001

Identifier Type: -

Identifier Source: org_study_id

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