Evaluating BA3071 for patients with solid tumors
A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
This study is testing a new treatment called BA3071 for patients with solid tumors like melanoma and certain types of lung cancer to see if it works well when combined with other therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BioAtla, Inc. Industry-sponsored |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Trial ID | NCT05180799 on ClinicalTrials.gov |
What this trial studies
This multi-center, open-label study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BA3071 in patients with solid tumors, specifically focusing on melanoma and nonsquamous or recurrent non-small cell lung cancer (NSCLC). The study includes two phases, with Phase 2 currently recruiting patients who have specific genetic mutations and are eligible for surgery. Participants will receive BA3071 along with other treatments such as Nivolumab, Pembrolizumab, or Pemetrexed. The study seeks to determine the effectiveness of BA3071 as a first-line treatment option for these cancers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with measurable disease and specific mutations in KRAS, STK11, KEAP1, or low PD-L1 expression.
Not a fit: Patients with significant cardiac disease, uncontrolled CNS metastasis, or a history of severe allergic reactions to monoclonal antibody therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced melanoma and NSCLC, potentially improving outcomes for those with specific genetic mutations.
How similar studies have performed: Other studies have shown promise with similar approaches targeting specific mutations in solid tumors, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must have measurable disease. * Age ≥ 18 years * CLTA-4 blocking-antibody naïve * Adequate renal function * Adequate liver function * Adequate hematological function * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS \<1% * Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only) Exclusion Criteria: * Patients must not have clinically significant cardiac disease. * Patients must not have known non-controlled CNS metastasis. * Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study. * Patients must not have had major surgery within 4 weeks before first BA3071 administration. * 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
Los Angeles, California and 11 other locations
- The Angeles Clinic and Research Institute — Los Angeles, California, United States (Recruiting)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Piedmont West — Atlanta, Georgia, United States (Recruiting)
- Northwest Cancer Centers — Dyer, Indiana, United States (Recruiting)
- Morristown Medical Center/Atlantic Health System — Morristown, New Jersey, United States (Not_yet_recruiting)
- Icahn School of Medicine at Mt. Sinai — New York, New York, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Providence Cancer Institute — Portland, Oregon, United States (Recruiting)
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
- Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre — Albury, New South Wales, Australia (Not_yet_recruiting)
- Cancer Care Foundation — Miranda, New South Wales, Australia (Recruiting)
- Cancer Research South Australia — Adelaide, South Australia, Australia (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.