Ovarian epithelial cancer metastatic Trials in Disease

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This clinical trial is investigating a new treatment called DS-3939a for patients with advanced cancers that have spread beyond their original location. The medication is given as a solution directly into the bloodstream through an intravenous infusion. The study includes patients with various types of advanced cancers, including ovarian cancer, as well as cancers of the lung, breast, bladder, bile duct, and pancreas.

Main inclusion criteria:

• You must be able to sign and understand the informed consent form
• Your heart must be pumping adequately, with a left ventricular ejection fraction of at least 50%, as measured by an ultrasound or special scan
• Your organs must be functioning well enough to participate
• Your cancer must be measurable according to standard criteria called RECIST V1.1
• You must have an ECOG performance status score of 0 or 1, meaning you are either fully active or able to carry out light work despite some symptoms
• For Part 1 of the study: You must have a confirmed diagnosis of locally advanced, metastatic, or unresectable cancer in specific organs including the ovary, regardless of the specific cancer type
• For Part 2 of the study: Your cancer must have progressed during or after your most recent treatment, as shown on scans
• For Part 2: You must be able to provide a tumor sample, either freshly taken or from a previous biopsy done within 6 months

Main exclusion criteria:

• You must be within the specific age range set for the study
• You cannot be part of a vulnerable population, such as those unable to give informed consent
• You must meet the safety and tolerability requirements for DS-3939a, meaning your body must be able to handle the drug without causing harmful effects

Focus and goal of the trial:

The trial is divided into two parts. The first part focuses on evaluating the safety of DS-3939a and how well patients tolerate the treatment. Researchers will monitor participants closely for any side effects or health changes through regular check-ups, laboratory tests, and imaging studies. The second part continues to assess safety while also measuring how effective the treatment is at the recommended dose. This involves looking at how tumors respond to the treatment, measured by the objective response rate, which shows the percentage of patients whose cancer shrinks or disappears after treatment.

Throughout the study, participants receive careful monitoring including physical examinations, vital sign checks, electrocardiograms, and other tests to track their progress and ensure their well-being. The study aims to gather important information that could lead to new treatment options for people with advanced cancers. The trial is expected to continue until July 2027.

Investigational drug:

DS-3939a is an experimental cancer therapy currently being tested for its potential in treating advanced and metastatic solid tumors. It works by targeting specific pathways that cancer cells use to grow and spread, although the exact mechanism is still under investigation. The medication is administered as an injection in a clinical setting by healthcare professionals. It is not yet approved for general medical use and remains under study to determine its safety, tolerability, and effectiveness.

Summary

Currently, there is one active clinical trial available for patients with metastatic ovarian epithelial cancer. This trial is being conducted in three European countries: Belgium, France, and Spain. The study focuses on DS-3939a, an investigational drug that is also being tested in patients with other types of advanced solid tumors, including cancers of the lung, breast, bladder, bile duct, and pancreas.

The trial offers an opportunity for patients whose cancer has progressed despite previous treatments to access a potentially new treatment option. The two-part study design allows researchers to first establish the safety profile of DS-3939a before evaluating its effectiveness, which is a common approach in early-stage cancer drug development.

Patients interested in this trial should discuss with their healthcare provider whether they meet the eligibility criteria and whether participation might be appropriate for their individual situation.