A Phase 2/3 Multicenter Randomized Study of Raludotatug Deruxtecan (R-DXd) a CDH6-directed Antibody-drug Conjugate in Subjects with Platinum-resistant High-grade Ovarian Primary Peritoneal or Fallopian Tube Cancer

Brief description of study

This is a Phase 2/3 study aimed at learning more about the study medicine Raludotatug Deruxtecan (R-DXd) as a treatment for ovarian cancer patients. R-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to specific targets on tumor cells to deliver chemotherapy directly to tumor cells and limit exposure to healthy cells. R-DXd specifically binds to tumor cells that are expressing CDH6 and releases the drug into the target cells to kill the tumor cells.

This study will be done in two phases. In phase 2, patients will be randomly divided into groups to receive the R-DXd at different dose levels. The study team will determine the dose that is most effective and has fewer side effects. To further confirm the safety and effectiveness of R-DXd more patients will be included in the study to receive R-DXd at the most effective dose. In phase 3 of the study, patients will be randomly divided into two groups. One group will receive the R-DXd drug, and the other group will receive standard chemotherapy medicine of the study doctor’s choice. The study team will monitor all patients to learn if patients have been cancer-free for a longer time or if patients survive longer on study medicine as compared to the standard chemotherapy. Blood samples will be collected from all patients to see how their bodies are handling the study medicine. All patients will have CT scans done to see how their cancer is responding to the study medicine. All patients will be closely watched for potential side effects and safety concerns.


Clinical Study Identifier: s23-01390
ClinicalTrials.gov Identifier: NCT06161025
Principal Investigator: Bhavana Pothuri.
Other Investigators: Anam Qureshi, Kent Chan, Cindy Corbo, Nitish Mehta, Deanna Gerber, Olivia Richardson Khouri, Laura Palazzolo, Marina Stasenko, Jonathan B Kahn, Fabia Brisard Pierrot, Alexander A Hindenburg, Leslie R Boyd, Christina Grace Wilson, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Carol M Lee, Whitfield B. Growdon, Anastasiya Apanasyuk, Victoria Helen Dowd, Rupal Bhana, Edward A Jimenez, Erin Annette Reese, Sabrina Machado, Kelly A Levine, Kathleen M Lutz.


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