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

Sponsor: Daiichi Sankyo

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06161025

Provider View

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

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.

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