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NCT05808634 | RECRUITING | Advanced Adenocarcinoma

Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.
Sponsor:

Bioatla, Inc.

Brief Summary:

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

Condition or disease

Advanced Adenocarcinoma

Intervention/treatment

BA3182

Phase

PHASE1

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
Estimated Enrollment : 168 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-07-14
Estimated Primary Completion Date : 2025-06-28
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

Location Details

NCT05808634

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

UC Irvine

Irvine, California, United States, 92697

RECRUITING

United States, California

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06511

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

University of Illinois

Chicago, Illinois, United States, 60612

RECRUITING

United States, Road cancer

Karmanos Cancer Institute

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Ohio

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States, 45219

RECRUITING

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

RECRUITING

United States, Washington

Fred Hutch Cancer Center

Seattle, Washington, United States, 98109