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

Brief description of study

This study wants to see if a medicine called disitamab vedotin (designed to go straight to cancer cells and slow down or shrink the cancer) can help patients with previously treated advanced or metastatic solid tumors that have HER2 expression. The study will evaluate patients in different groups based on the type of cancer they have, like lung cancer or ovarian cancer, and each group will be studied to see if disitamab vedotin works in specific cancer types. To join the study, you need to have had treatment for your cancer before, but it didn't work very well, and your cancer got worse. You also need to have cancer that can be measured, feel relatively okay, and have your body working normally. The medicine will be given every two weeks until it either doesn't work anymore, or you have some serious side effects, get pregnant, or decide not to continue. They will check how your cancer is doing with tests and watch out for any side effects. There will also be some extra tests (such as CT scan tumor evaluations and other pharmacokinetic and pharmacodynamic sampling) for some people to understand more about how the medicine works.


Clinical Study Identifier: s23-00576
ClinicalTrials.gov Identifier: NCT06003231
Principal Investigator: Bhavana Pothuri.
Other Investigators: Kent Chan, Elaine Shum, Michael Persky, David Mendoza, Colin Hill, Olivia Richardson Khouri, Vamsidhar Velcheti, Joshua K Sabari, Tuyet-Phuong N Tran, Marina Stasenko, Fabia Brisard Pierrot, Caitlin Elizabeth Ryan, Kathleen M Lutz, Leslie R Boyd, Christina Grace Wilson, Salman Rafi Punekar, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Catherine M Concert, Sally Lau, Whitfield B. Growdon, Elise M Zahriah, Zujun Li, Samantha VanMaanen, Kelly A Levine, Edward A Jimenez, Erin Annette Reese, Adam S Jacobson, Kenneth S Hu, Melissa L Martinez, Ann M Riccobene, Alexander A Hindenburg, Deanna Gerber.


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