COMPLETED

A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Talk to us

Conditions

Head and Neck CancerSquamous Cell Carcinoma of Head and NeckRecurrent Squamous Cell Carcinoma of the Head and NeckMetastatic CancerMetastatic Squamous Cell Carcinoma of the Head and NeckCancer

Quick Navigation

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

This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 as monotherapy and combination therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Official Title

A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Quick Facts

Study Start:2022-12-13
Study Completion:2025-09-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05271604

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. * The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
  2. * 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.
  3. * 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).
  4. * 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.
  5. * 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.
  6. * Age ≥ 18 years
  7. * Adequate renal function
  8. * Adequate liver function
  9. * Adequate hematological function
  10. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  1. * 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.
  2. * Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
  3. * Patients must not be women who are pregnant or are breast feeding.

Contacts and Locations

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Christiana Care Helen Graham Cancer Center
Newark, Delaware, 19713
United States
Northwestern University
Chicago, Illinois, 60611
United States
Norton Cancer Institute
Louisville, Kentucky, 40202
United States
Washington University Medical Siteman Cancer Center
St Louis, Missouri, 63110
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
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 Date2022-12-13
Study Completion Date2025-09-22

Study Record Updates

Study Start Date2022-12-13
Study Completion Date2025-09-22

Terms related to this study

Keywords Provided by Researchers

  • Cancer

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Recurrent Squamous Cell Carcinoma of the Head and Neck
  • Metastatic Cancer
  • Metastatic Squamous Cell Carcinoma of the Head and Neck