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

Inclusion Criteria

• •Cohort 1: Head and neck cancer (HNC)
• •* Must have pathologically-documented carcinoma of the head and neck with primary tumor site arising from the oral cavity, salivary gland, oropharynx, hypopharynx, and larynx; tumors arising from the nasopharynx are excluded.
• •* Unresectable locally recurrent or metastatic stage disease
• •* Prior therapies:
• •* Participants must have disease progression after treatment with a platinum-based therapy
• •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 for LA/metastatic disease 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
• •* Participants with known AGAs must have received appropriate targeted therapy, where available.
• •* 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
• •* Participants with known BRCA mutations are permitted, but participants must have received targeted therapy with a PARP inhibitor
• •* 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