Inflammatory carcinoma of breast 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 investigational treatment for patients with advanced or metastatic solid tumors, including inflammatory breast cancer that has spread to other parts of the body. The medication is given directly into the bloodstream through an intravenous infusion. The study is divided into two parts: the first focuses on evaluating the safety and how well patients tolerate the treatment, while the second part continues to assess safety and measures how effective the treatment is at fighting cancer.

Main inclusion criteria:

• Patients must sign an informed consent form showing they understand and agree to participate
• Heart function must be adequate, with a left ventricular ejection fraction of at least 50%
• Organ function must be adequate for participating safely in the study
• Cancer must be measurable using standard assessment criteria
• Performance status score must be 0 or 1, meaning patients can carry out daily activities with no or minimal limitations
• For Part 1: Patients must have confirmed locally advanced, metastatic, or unresectable cancer affecting the bladder, lung, breast, ovary, bile duct, or pancreas
• For Part 2: Patients must have cancer that has progressed during or after their most recent treatment, confirmed by scans
• For Part 2: Patients must be able to provide a tumor sample, either freshly taken or from a previous procedure within the past 6 months

Main exclusion criteria:

• Patients outside the specified age range for the study cannot participate
• Vulnerable populations, such as pregnant women or those unable to provide informed consent, are excluded
• Patients who do not meet the safety and tolerability requirements for DS-3939a cannot participate

Focus and goal:

The primary goal of this trial is to evaluate the safety and tolerability of DS-3939a in patients with advanced solid tumors. Researchers want to understand if the medication causes any harmful side effects and how well patients' bodies handle the treatment. The study also aims to measure the effectiveness of the treatment by looking at how tumors respond, specifically measuring the objective response rate, which indicates the percentage of patients whose cancer shrinks or disappears after treatment. Throughout the trial, participants will be closely monitored with regular check-ups, laboratory tests, imaging studies, and assessments of heart function and vital signs. The study is expected to conclude by July 2027.

Investigational drug:

DS-3939a is the investigational medication being tested in this trial. It is an experimental cancer therapy designed to target specific pathways that cancer cells use to grow and spread. The drug is administered as an injection in a clinical setting by healthcare professionals. DS-3939a is currently being studied specifically for its potential to treat advanced and metastatic solid tumors. At this stage, it is not yet approved for general medical use, and the exact mechanism of how it works at the molecular level is still under investigation. The trial will help determine whether this new treatment could offer a potential option for patients with difficult-to-treat cancers.

Summary

Currently, there is one ongoing clinical trial available for patients with inflammatory carcinoma of breast stage IV. This trial is being conducted in three European countries: Belgium, France, and Spain, providing access to patients across these regions. The study focuses on testing DS-3939a, an experimental intravenous treatment for patients with advanced or metastatic solid tumors, including breast cancer. The trial is particularly relevant for patients whose cancer has progressed despite previous treatments and who meet specific health and functional criteria. The emphasis on both safety assessment and effectiveness measurement reflects a comprehensive approach to understanding this new investigational drug. Patients interested in participating should discuss eligibility requirements with their healthcare providers, as the trial has specific criteria regarding heart function, organ function, and disease characteristics.