Evaluating BA3182 for advanced adenocarcinoma treatment
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
This study is testing a new treatment called BA3182 to see if it is safe and effective for people with advanced adenocarcinoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BioAtla, Inc. Industry-sponsored |
| Locations | 9 sites (Irvine, California and 8 other locations) |
| Trial ID | NCT05808634 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BA3182 in patients diagnosed with advanced adenocarcinoma. It is a multi-center, open-label trial that includes patients with locally advanced unresectable or metastatic forms of the disease. Participants will receive BA3182 and will be monitored for various health parameters to determine the treatment's efficacy and safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed locally advanced unresectable or metastatic adenocarcinoma and adequate organ function.
Not a fit: Patients with significant cardiac disease, active autoimmune diseases, or uncontrolled CNS metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced adenocarcinoma.
How similar studies have performed: Other studies evaluating similar immunotherapeutic approaches have shown promise, but this specific treatment is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Irvine, California and 8 other locations
- UC Irvine — Irvine, California, United States (Recruiting)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Illinois — Chicago, Illinois, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- The Christ Hospital Cancer Center — Cincinnati, Ohio, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Fred Hutch Cancer Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: BioAtla Medical Affairs
- Email: medicalaffairs@bioatla.com
- Phone: 858-558-0708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.