RECRUITING

Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

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Conditions

Advanced AdenocarcinomaAdvancedMetastaticCancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-07-14
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05808634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
  2. * Age ≥ 18 years
  3. * Adequate renal function
  4. * Adequate liver function
  5. * Adequate hematological function
  6. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  1. * Patients must not have clinically significant cardiac disease.
  2. * Patients must not have known non-controlled CNS metastasis.
  3. * Patients must not have active autoimmune disease or a documented history of autoimmune disease.
  4. * 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.
  5. * Patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
  6. * Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
  7. * Patients must not be women who are pregnant or breast feeding.

Contacts and Locations

Study Contact

Ji Hwan Lee
CONTACT
18582867702
jlee@bioatla.com

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Yale Cancer Center
New Haven, Connecticut, 06511
United States
University of Illinois
Chicago, Illinois, 60612
United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: BioAtla, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-14
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-07-14
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Advanced
  • Metastatic
  • Cancer

Additional Relevant MeSH Terms

  • Advanced Adenocarcinoma