A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

Open to people ages 18 years and up

• 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

• 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