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

Phase 1

• Conditions: Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms, Carcinoma, Squamous Cell of Head and Neck; MedDRA version: 26.1Level: PTClassification code: 10060121Term: Squamous cell carcinoma of head and neck Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864; MedDRA version: 21.0Level: PTClassification code: 10014733Term: Endometrial cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504445-31-00
• Lead Sponsor: Seagen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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. Note: Subjects 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified