Head and neck squamous cell carcinoma/Non-small cell lung cancer/Ovarian cancer/Endometrial cancer
Conditions
Interventions
Experimental Arm
- Disitamab vedotin 1.5 mg/kg administered intravenously (IV) every 2 weeks
Sponsors
Xuemei Li
Eligibility
Sex/Gender
All
Inclusion criteria
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-programmed cell death protein 1 and programmed death ligand 1 (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 immunohistochemistry (IHC) testing on a fresh or archival tumor tissue. Note: Participants with HER2 mutations are eligible. - Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by the investigator - Able to provide formalin-fixed, paraffin-embedded tumor tissue blocks (or freshly sectioned slides) - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion criteria
Exclusion criteria: - Prior treatment with a monomethyl auristatin E (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 central nervous system or leptomeningeal metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of participants with adverse events (AEs) - Number of participants with laboratories abnormalities - Number of participants with dose alterations due to AEs - Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment - Duration of Response (DOR) per RECIST v1.1 by investigator assessment - Progression free survival (PFS) per RECIST v1.1 by investigator assessment - Overall Survival (OS) - Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast) - PK parameter - Maximum concentration (Cmax) - PK parameter - Trough concentration (Ctrough) - Incidence of antidrug antibodies (ADAs) | — |
Countries
Australia, Canada, Italy, Japan, Republic of Korea, Spain, United Kingdom, United States
Contacts
Public ContactClinical trial contact
ICON Clinical Research GK
Outcome results
None listed