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NCT05271604 | RECRUITING | Head and Neck Cancer

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

Bioatla, Inc.

Brief Summary:

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.

Condition or disease

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

Intervention/treatment

Ozuriftamab Vedotin

Pembrolizumab

Evalstotug (BA3071)

Cetuximab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 290 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-12-13
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Phase 2 Open Label Study of BA3021 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Location Details

NCT05271604

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, Delaware

Christiana Care Helen Graham Cancer Center

Newark, Delaware, United States, 19713

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Missouri

Washington University Medical Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New York

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065

WITHDRAWN

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112