A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor 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 tumors 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. This study is being done to see if DV works to treat different types of solid tumors 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:
🦠 Carcinoma, Squamous Cell of Head and Neck 🦠 Carcinoma, Non-Small-Cell Lung 🦠 Ovarian Neoplasms 🦠 Endometrial Neoplasms
🗓️ Study Start (Actual) 14 November 2023
🗓️ Primary Completion (Estimated) 31 May 2026
✅ Study Completion (Estimated) 31 May 2028
👥 Enrollment (Estimated) 160
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Chandler, Arizona, United States
📍 Los Angeles, California, United States
📍 Sacramento, California, United States
📍 Santa Rosa, California, United States
📍 Grand Junction, Colorado, United States
📍 New Haven, Connecticut, United States
📍 Norwich, Connecticut, United States
📍 Miami, Florida, United States
📍 Augusta, Georgia, United States
📍 Boston, Massachusetts, United States
📍 Detroit, Michigan, United States
📍 Saint Louis Park, Minnesota, United States
📍 Billings, Montana, United States
📍 Albuquerque, New Mexico, United States
📍 Mineola, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Durham, North Carolina, United States
📍 Canton, Ohio, United States
📍 Portland, Oregon, United States
📍 Portland, Oregon, United States
📍 El Paso, Texas, United States
📍 Houston, Texas, United States
📍 The Woodlands, Texas, United States
📍 Seattle, Washington, United States
📍 Seattle, Washington, United States
📍 Blacktown NSW, Other, Australia
📍 Brisbane, Other, Australia
📍 Frankston, Other, Australia
📍 Toronto, Ontario, Canada
📍 Montreal, Quebec, Canada
📍 Quebec, Canada

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Cohort 1: Head and neck squamous cell carcinoma (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: Non-small cell lung cancer (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. Note: Participants with HER2 mutations are eligible.
    • * 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 Criteria:

    • * Prior treatment with an MMAE-containing agent.
    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 August 2023
  • First Submitted that Met QC Criteria 15 August 2023
  • First Posted 21 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024