A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms
About this trial
This is an interventional treatment trial for Carcinoma, Squamous Cell of Head and Neck focused on measuring HNSCC, NSCLC, Ovarian Cancer, Endometrial Cancer
Eligibility Criteria
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
Sites / Locations
- Providence Medical FoundationRecruiting
- Eastern CT Hematology and Oncology AssociatesRecruiting
- St. Vincent Frontier Cancer CenterRecruiting
- NYU Langone HospitalRecruiting
- NYU Langone HospitalRecruiting
- Gabrail Cancer Center Research, LLCRecruiting
- Renovatio ClinicalRecruiting
- MD Anderson Cancer Center / University of TexasRecruiting
- Renovatio ClinicalRecruiting
- CHU de Quebec-Universite LavalRecruiting
Arms of the Study
Arm 1
Experimental
Disitamab vedotin monotherapy
Disitamab vedotin monotherapy