NCT06003231

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

A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. In the first part of the study, 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.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Ovarian Neoplasms
• Endometrial Neoplasms
• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	disitamab vedotin	Given into the vein (IV, intravenous) every 2 weeks

Timeline

• Start date: 2023-11-14
• Primary completion: 2026-05-31
• Completion: 2028-05-31
• First posted: 2023-08-21
• Last updated: 2026-04-07

Locations

94 sites across 7 countries: United States, Australia, Canada, Italy, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study