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

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Female (cisgender)
Transgender male
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

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

Angeles
Secord

Protocol Number

PRO00115756

NCT ID

NCT06161025

Phase

II/III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov