Phase 2 Study of BA3021 for Treating Recurrent or Metastatic Head and Neck Cancer

Sponsor: BioAtla, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05271604

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment, BA3021, for patients with head and neck cancer that has returned or spread. The study will look at how well the treatment works on its own and in combination with other therapies.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a new treatment called BA3021 works for patients with squamous cell carcinoma of the head and neck that has come back or spread to other parts of the body. The study will test BA3021 both by itself and in combination with other treatments to see if it can help control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Cancer located in the oropharynx, oral cavity, hypopharynx, or larynx. Cancer in the nasopharynx is not eligible.
  • For newly diagnosed Stage III cancer: Must be eligible for treatment before surgery and have not received any prior treatments.
  • For recurrent or metastatic cancer: Must have confirmed Stage III/IV cancer that cannot be treated with surgery or radiation to cure it.
  • For first-line treatment: Must not have received any prior systemic therapy for cancer that has come back or spread.
  • For second-line treatment: Must have tried one previous treatment that included a PD-1/L1 inhibitor and it did not work.
  • Must have measurable cancer that can be tracked.
  • Must be 18 years or older.
  • Must have good kidney, liver, and blood health.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Must not have had severe allergic reactions to similar treatments or be allergic to any study medications.
  • Must not have HIV, active hepatitis B, or hepatitis C infections.
  • Must not be pregnant or breastfeeding.

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