Study on New Treatments for HPV16+ Recurrent or Metastatic Head and Neck Cancer and Other Cancers

Sponsor: Hookipa Biotech GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04180215

Provider View

This clinical trial is testing new treatments, HB-201 and HB-202, for patients with HPV16+ head and neck cancer that has returned or spread. The study aims to see if these treatments, used alongside standard care, are safe and effective.

Patient Parameters

Program Overview

This study is exploring new treatments, HB-201 and HB-202, designed to help the body recognize and fight HPV16+ cancers. The trial is open to patients with head and neck cancer that has come back or spread, and who are eligible for the standard treatment with pembrolizumab. The study is divided into two parts: Phase I, which focuses on finding the right dose, and Phase II, which looks at how well the treatment works.

Description

The trial involves two new drugs, HB-201 and HB-202, which aim to train the immune system to target HPV16+ cancer cells. The study is enrolling patients with head and neck cancer that has either returned or spread. Participants will receive these study drugs in addition to their usual treatment with pembrolizumab, a standard cancer therapy. The trial is conducted in two phases: the first phase determines the safest dose, and the second phase evaluates the effectiveness of the treatment.

Eligibility Criteria

Exclusion Criteria

  • Cancer that has spread to the brain or spinal cord, or cancer in the brain's lining.
  • Serious or uncontrolled medical conditions that could increase risks during the study.
  • Another active cancer that needs treatment, unless specific criteria are met.
  • Autoimmune or inflammatory disorders needing immunosuppressive therapy.
  • Life expectancy of less than 3 months.
  • Unresolved side effects from previous cancer treatments, unless specific criteria are met.
  • Not meeting required waiting periods for certain medications.
  • Severe allergic reactions to the study drugs or their ingredients.
  • Active hepatitis B or C infection.
  • History of AIDS.

Additional criteria for certain groups:

  • Severe allergic reaction to pembrolizumab.
  • History of lung inflammation needing treatment.
  • Stopped previous treatment due to severe immune-related side effects.

For specific participants at Memorial Sloan Kettering Cancer Center:

  • Spleen disorders or previous spleen removal that could affect study goals.

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