A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2
Trial Description
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.
Eligibility Requirements
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