Study on Raludotatug Deruxtecan (R-DXd) for Patients with Platinum-resistant Ovarian, Peritoneal, or Fallopian Tube Cancer

Sponsor: Daiichi Sankyo

Sponsor score: 40

ClinicalTrials ID:NCT06161025

This clinical trial is testing a new treatment called R-DXd for patients with certain types of ovarian, peritoneal, or fallopian tube cancer that have not responded to platinum-based chemotherapy.

Patient Parameters

Parameter	Options

Program Overview

The study aims to evaluate the safety and effectiveness of R-DXd, a new drug designed to target cancer cells in patients with platinum-resistant ovarian, peritoneal, or fallopian tube cancer. The trial will determine the best dose of R-DXd and compare its effects to standard chemotherapy options.

Description

This study focuses on a new treatment called R-DXd for patients with specific types of cancer that have not responded to platinum-based chemotherapy. R-DXd is a drug that targets a protein called CDH6, which is found in high amounts on certain cancer cells. The study is divided into two parts: Part A will find the best dose of R-DXd based on safety and effectiveness, while Part B will compare R-DXd to standard chemotherapy treatments to see which works better.

Eligibility Criteria

Inclusion Criteria

Must be 18 years or older.
Have a confirmed diagnosis of high-grade ovarian, peritoneal, or fallopian tube cancer.
Must have at least one tumor that can be biopsied and agree to provide tissue samples.
Have received 1 to 3 previous cancer treatments.
Have cancer that did not respond to platinum-based chemotherapy.
Have at least one measurable tumor on scans.
Be in good overall health with a performance status of 0 or 1.
Meet specific blood test requirements for liver and kidney function.
Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
Be willing to follow study procedures and attend all visits.

Exclusion Criteria

Have a different type of cancer than those being studied.
Have active or untreated brain metastases.
Have significant heart problems or uncontrolled high blood pressure.
Have severe lung conditions or a history of lung inflammation.
Have unresolved side effects from previous cancer treatments.
Have active infections like hepatitis B, hepatitis C, or HIV that are not well controlled.
Be pregnant or breastfeeding.
Have received a live vaccine within 30 days before starting the study.

Locations

FACILITY	ZIP	CITY	STATE
University of Miami Miller School of Medicine	33136	Miami	Florida
NYU Langone Health	10016	New York	New York
University of Oklahoma Health Sciences Center	73104	Oklahoma City	Oklahoma
Oklahoma Cancer Specialists and Research Institute	12967	Tulsa	Oklahoma

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