RecruitingPhase 1NCT05808634

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


Sponsor

BioAtla, Inc.

Enrollment

168 participants

Start Date

Jul 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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.

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Interventions

DRUGBA3182

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


Locations(9)

UC Irvine

Irvine, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Fred Hutch Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05808634


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