Study on Disitamab Vedotin for Previously Treated Solid Tumors with HER2 Marker

Sponsor: Seagen Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06003231

Provider View

This clinical trial is testing a new drug, disitamab vedotin, for treating advanced or metastatic solid tumors that have a specific marker called HER2. The study aims to see if the drug is effective and safe for patients with certain types of cancer.

Patient Parameters

Program Overview

This study is for patients with advanced or metastatic solid tumors, which means the cancer has grown large in one area or spread to other parts of the body. Participants must have head and neck cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer, and their tumors must have a marker called HER2. The trial uses an experimental drug called disitamab vedotin (DV), which is designed to attach to cancer cells and kill them. All participants will receive DV every two weeks. The study will evaluate how well DV works in treating these cancers and what side effects it may cause.

Eligibility Criteria

Inclusion Criteria

  • Head and Neck Cancer:
    • Cancer in areas like the mouth, throat, or voice box.
    • Cancer that cannot be removed by surgery or has spread.
    • Must have worsened after platinum-based treatment.
    • No more than one previous chemotherapy for advanced cancer.
  • Non-Small Cell Lung Cancer:
    • Cancer that cannot be removed by surgery or has spread.
    • Must have worsened during or after platinum-based treatment.
    • Must have had anti-PD(L)1 therapy unless not suitable.
    • No more than two previous chemotherapies for advanced cancer.
  • Ovarian Cancer:
    • Cancer in the ovaries, fallopian tubes, or peritoneum.
    • Cancer that cannot be removed by surgery or has spread.
    • Must have platinum-resistant cancer.
    • No more than four previous chemotherapies for advanced cancer.
    • May have had anti-PD(L)1 therapy.
  • Endometrial Cancer:
    • Cancer in the lining of the uterus.
    • Cancer that cannot be removed by surgery or has spread.
    • Must have worsened after at least one platinum-based treatment.
    • No more than three previous chemotherapies for advanced cancer.
    • May have had anti-PD(L)1 therapy.
  • Tumors must have HER2 marker (1+, 2+, or 3+).
  • Must have measurable cancer.
  • Must provide a tumor sample.
  • Must be in good overall health with a performance status of 0 or 1.

Exclusion Criteria

  • Previous treatment with a drug similar to disitamab vedotin.
  • Allergy to any ingredient in disitamab vedotin.
  • Another invasive cancer within the last two years.
  • Active, untreated cancer in the brain or spinal fluid.

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