Evaluating BA3021 for patients with recurrent or metastatic head and neck cancer
A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
This study is testing a new treatment called BA3021 for people with recurrent or metastatic head and neck cancer to see if it can help them feel better and improve their outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BioAtla, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 8 sites (Los Angeles, California and 7 other locations) |
| Trial ID | NCT05271604 on ClinicalTrials.gov |
What this trial studies
This Phase 2 open-label study aims to assess the efficacy and safety of BA3021 in patients suffering from recurrent or metastatic squamous cell carcinoma of the head and neck. The study will involve multiple treatment cohorts, including monotherapy and combination therapy with agents such as Ozuriftamab Vedotin and Pembrolizumab. Eligible patients will include those with newly diagnosed Stage III disease and those with recurrent or metastatic disease not suitable for curative local therapy. The study will focus on various tumor locations, excluding nasopharyngeal sites.
Who should consider this trial
Good fit: Ideal candidates include patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have not received prior systemic therapy.
Not a fit: Patients with nasopharyngeal tumors or those who have previously received systemic therapy for their condition 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 head and neck cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology). * Neoadjuvant/induction setting (Cohort N1): Patient with newly diagnosed Stage III SCCHN who are eligible for induction therapy with resectable tumors. No prior treatments, including surgery, radiation, or systemic treatment, for SCCHN are allowed. * Recurrent or metastatic setting: Histologically or cytologically confirmed recurrent or metastatic SCCHN Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). * First-line - Combination Cohorts (C1 and C2): Patients must have NO prior systemic therapy administered in the locally recurrent or metastatic setting. Previous treatments with PD-1/L1 inhibitor or anti-CTLA-4 treatment are not allowed. * Second-line (Combination Cohort C3) and Second-line+ (Monotherapy Cohorts M1 and M2): Patients must have documented treatment failure of no more than one approved PD-1/L1 inhibitor either administered alone or in combination. Patients must have measurable disease. * 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 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 known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C. * Patients must not be women who are pregnant or are breast feeding.
Where this trial is running
Los Angeles, California and 7 other locations
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Christiana Care Helen Graham Cancer Center — Newark, Delaware, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Norton Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- Washington University Medical Siteman Cancer Center — Saint Louis, Missouri, United States (Recruiting)
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Withdrawn)
- Huntsman Cancer Institute — Salt Lake City, Utah, 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.