Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

GOG-3096 DS6000-109 (Ovarian, Primary Peritoneal, and Fallopian Tube Cancers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find the most effective, safe dose of an experimental drug called raludotatug deruxtecan (the study drug) and to see if your disease or medical condition improves while taking it.

What is the Condition Being Studied?

Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • Have received at least 1, but no more than 3, previous lines of anticancer therapy
  • Have platinum-resistant disease

For more information about who can join this study, please contact the study team at gynoncclinicaltrials@duke.edu or 919-684-3780.

Age Group
Adults

What is Involved?

This is a 2-part study, and you will be enrolled in only 1 of the 2 parts. The first part, called Part A, is to see how well the study drug works. If you are enrolled in this part, you will be assigned to one of three different doses of study drug. If you are enrolled in Part B, you will receive either the study drug or one of the standard drugs used to treat your diagnosis that will be used for comparison. Whether you participate in Part A or Part B of the study will depend on when you join.

If you are in Part A, you will:

  • Get a dose of the study drug once every 4 weeks
  • Take the study drug for as long as you and the study doctor believe you are getting a positive benefit from it

If you are in Part B, you will:

  • Get a dose of the study drug once every 4 weeks; OR
  • Receive a drug called topotecan rather than the study drug; OR
  • Receive a drug called paclitaxel rather than the study drug; OR
  • Receive a drug called gemcitabine rather than the study drug

You will continue whatever assigned regimen you have in Part B for as long as you and the study doctor believe you are getting a positive benefit from it.

Study Details

Full Title
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
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB: PRO00115756
NCT: NCT06161025
Phase
Phase II/III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
More Information