Ovarian germ cell cancer stage IV Trials in Disease

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

This clinical trial is investigating DS-3939a, a new experimental treatment delivered through intravenous infusion for patients with advanced or metastatic solid tumors. The study includes patients with ovarian cancer, among other cancer types such as lung, breast, bladder, bile duct, and pancreatic cancers.

Main inclusion criteria:

• Patients must sign an informed consent form and understand the trial requirements
• Heart function must be adequate, with a left ventricular ejection fraction of at least 50%
• All major organs must be functioning properly
• The cancer must be measurable according to standard measurement criteria (RECIST V1.1)
• Patients must have an Eastern Cooperative Oncology Group performance status score of 0 or 1, meaning they are fully active or have some symptoms but can still carry out light work
• For the first part of the study, patients must have a confirmed diagnosis of locally advanced, metastatic, or unresectable cancer in specific organs including the ovary
• For the second part of the study, the cancer must have progressed during or after the most recent treatment
• A tumor sample must be available, either from a fresh biopsy during screening or from a previous biopsy or surgery performed within 6 months before joining the trial

Main exclusion criteria:

• Patients who do not fall within the specified age range for the study
• Patients who belong to vulnerable populations, such as pregnant women or those unable to provide informed consent
• Patients who do not meet the safety and tolerability requirements for DS-3939a

Focus and goal of the trial:

The trial is divided into two parts. The first part focuses on assessing the safety and tolerability of DS-3939a, monitoring patients closely for any side effects or adverse reactions. The second part continues to evaluate safety while also measuring the treatment's effectiveness at a recommended dose. This effectiveness is measured by the objective response rate, which looks at how the cancer responds to treatment, such as whether tumors shrink or disappear.

Throughout the study, participants undergo regular check-ups, laboratory tests, electrocardiograms, vital sign monitoring, and imaging studies to track their health and the progress of treatment. The study aims to gather important information that could lead to new treatment options for people with advanced solid tumors. The trial is estimated to complete by July 2027.

Investigational drug:

DS-3939a is an experimental medication administered directly into the bloodstream through a vein. It is designed to target specific pathways that cancer cells use to grow and spread. The exact mechanism of how it works is still under investigation. The trial aims to determine if DS-3939a is safe for patients and how well it works in shrinking or controlling tumors. The dosage, frequency, and duration of treatment are determined by the study protocol and each patient's specific needs.

Summary

Currently, there is only one clinical trial available for patients with ovarian germ cell cancer stage IV. This trial is being conducted across three European countries: Belgium, France, and Spain. The study focuses on testing DS-3939a, an investigational drug that targets advanced and metastatic solid tumors, including ovarian cancer. The trial includes patients with various types of advanced cancers and is structured in two phases to evaluate both safety and effectiveness. Patients interested in participating should note that the trial has specific eligibility requirements related to heart function, organ health, and cancer progression status. The trial represents an opportunity for patients with advanced disease to access a new experimental treatment approach.