A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: November 14, 2023
End Date: May 31, 2028
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