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RecruitingLast updated: 5 April 2024

This study aims to see whether an experimental drug called disitamab vedotin works to treat different types of solid cancers that express HER2A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

Clinical summary

Summary

This clinical trial is studying advanced or metastatic solid cancers. Once a solid cancer has grown very large in one spot or has spread to other places in the body, it is called advanced or metastatic cancer. Participants in this study must have head and neck squamous cell cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. Participants must have tumours that have a marker called HER2.

This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In this study, all participants will get DV once every 2 weeks.

The study is being done to see if DV works to treat different types of solid cancers that express HER2. It will also test how safe the drug is for participants. This trial will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Conditions

This trial is treating patients with squamous cell carcinoma of the head and neck, non-small cell lung cancer, ovarian cancer, or endometrial cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Seagen Inc.

Scientific Title

A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

Eligibility

Inclusion

  • Cohort 1: HNSCC

    • Pathologically-documented squamous cell carcinoma of the head and neck with primary tumor site arising from the oral cavity, oropharynx, hypopharynx, and larynx
    • Unresectable locally recurrent or metastatic stage disease
    • Prior therapies:

      • Participants must have disease progression after treatment with a platinum-based therapy
      • No more than 1 line of cytotoxic chemotherapy for advanced disease
  • Cohort 2: NSCLC

    • Pathologically documented NSCLC
    • Unresectable locally-advanced or metastatic stage disease
    • Prior therapies

      • Must have progressed during or after a platinum-based therapy or, within 6 months of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiotherapy for early or locally-advanced stage disease
      • Must have received prior anti-PD(L)1 therapy, unless contraindicated
      • No more than 2 prior lines of cytotoxic chemotherapy for advanced disease
  • Cohort 3: Ovarian Cancer

    • Pathologically documented epithelial cancers of ovarian, fallopian tube, or peritoneal origin
    • Unresectable locally-advanced or metastatic stage disease
    • Prior therapies

      • Must have platinum resistant disease (6 months or less between the completion of platinum-based treatment and identification of recurrence)
      • Must not have received more than 4 lines of prior cytotoxic chemotherapies for advanced disease
      • May have received prior anti-PD(L)1 therapy
  • Cohort 4: Endometrial Cancer

    • Must have pathologically documented adenocarcinoma of the endometrium
    • Must have unresectable locally-advanced or metastatic stage disease.
    • Prior therapies

      • Must have relapsed/progressed after at least one prior platinum-based chemotherapy for recurrent, metastatic or primary unresectable disease
      • Must not have received more than 3 lines of prior cytotoxic chemotherapies for advanced disease
      • May have received prior anti-PD(L)1 therapy
  • HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue
  • Measurable disease per RECIST v1.1 criteria as assessed by the investigator
  • Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides)
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion

  • Prior treatment with an MMAE-containing agent.
  • Previous treatment with HER2-directed ADCs
  • Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin.
  • History of another invasive malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
  • Active untreated CNS or leptomeningeal metastasis

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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