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

Inclusion Criteria:

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 Criteria:

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