Recruiting

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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced solid tumors, which are types of cancer that have spread beyond their original location and are difficult to treat. The trial will test a new treatment called DS-3939a, which is given as a solution through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to evaluate the safety and tolerability of DS-3939a and to see how well it works in treating these advanced cancers.

The study is divided into two parts. In the first part, participants will receive DS-3939a to assess its safety and how well it is tolerated by the body. In the second part, the study will continue to evaluate safety and also measure the treatment's effectiveness at a recommended dose. This will involve looking at how the cancer responds to the treatment, which is known as the objective response rate. Participants may have different types of advanced cancers, including those of the lung, breast, ovary, and pancreas, among others.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. This includes regular check-ups, laboratory tests, and imaging studies to track the progress of the treatment. The study aims to gather important information that could lead to new treatment options for people with advanced solid tumors. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of DS-3939a.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will sign and date the main Informed Consent Form (ICF). This document confirms the patient's understanding and agreement to participate in the trial.
The patient will undergo an assessment to ensure they have a left ventricular ejection fraction of at least 50%, which is a measure of heart function, and adequate organ function.
Step 2
Initial assessments
The patient will have a measurable disease based on specific criteria known as RECIST V1.1, which helps in evaluating the size and response of tumors.
The patient's performance status will be assessed using the Eastern Cooperative Oncology Group (ECOG) score, which ranges from 0 to 1, indicating the patient's level of functioning.
Step 3
Treatment administration
The patient will receive the medication DS-3939a through an intravenous infusion. This means the medication will be administered directly into the bloodstream through a vein.
The dosage, frequency, and duration of the administration will be determined by the study protocol and the patient's specific needs.
Step 4
Monitoring and evaluations
Throughout the trial, the patient will be monitored for safety and tolerability of the medication. This includes checking for any side effects or adverse reactions.
Regular assessments will be conducted, including laboratory tests, electrocardiograms (ECG), vital signs, and physical examinations to ensure the patient's well-being.
Step 5
Response assessment
The patient's response to the treatment will be evaluated using the Objective Response Rate (ORR), which measures the percentage of patients whose cancer shrinks or disappears after treatment.
Additional assessments may include measuring the Disease Control Rate (DCR), Duration of Response (DoR), and other parameters to understand the effectiveness of the treatment.
Step 6
Completion of the trial
Upon completion of the trial, the patient will undergo a final evaluation to assess their overall health and the outcomes of the treatment.
The study is estimated to end by July 11, 2027, and the patient will be informed of any follow-up procedures or additional care required.

Who can join the trial?

8 criteria

Sign and date the main Informed Consent Form (ICF).
Have a left ventricular ejection fraction of 50% or higher. This is a measure of how well your heart is pumping blood, checked by a heart ultrasound or a special scan within 28 days before joining the study.
Have adequate organ function, meaning your organs are working well enough to participate in the study.
Have a measurable disease based on RECIST V1.1, which is a standard way to measure how cancer responds to treatment.
Have an Eastern Cooperative Oncology Group performance status score of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
For Part 1: Have a confirmed diagnosis of locally advanced, metastatic, or unresectable cancer in the bladder, lung, breast, ovary, bile duct, or pancreas, regardless of specific cancer types.
For Part 2: Have a confirmed diagnosis of locally advanced, metastatic, or unresectable cancer that meets the study's criteria and shows disease progression on scans during or after the most recent cancer treatment.
For Part 2: Be able to provide a baseline tumor sample, either a fresh sample taken during the screening period or a sample from a previous biopsy or surgery done within 6 months before signing the ICF.

Who cannot join the trial?

4 criteria

Patients with a **metastatic solid tumor** or **advanced solid tumor** cannot participate. A **metastatic solid tumor** is a type of cancer that has spread from its original location to other parts of the body. An **advanced solid tumor** is a cancer that has grown significantly and may have spread to other areas.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which may include groups like pregnant women or those unable to give consent, cannot participate.
Patients who do not meet the safety and tolerability requirements for the study drug, DS-3939a, cannot participate. **Safety and tolerability** refer to how the body handles the drug and whether it causes any harmful effects.

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Verified sites

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Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

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Investigated drugs

DS-3939a is a new medication being tested in this clinical trial. It is designed to help treat advanced solid tumors, which are a type of cancer that forms in the body's tissues. The trial aims to find out if DS-3939a is safe for people to use and how well it works in treating these tumors. The study is divided into two parts: the first part focuses on understanding the safety and any side effects of DS-3939a, while the second part looks at how effective the medication is at shrinking or controlling the tumors.

Ds-3939A

What is already known about the treatment

DS-3939a – DS-3939a is administered as an injection, typically given in a clinical setting by healthcare professionals. It is currently being studied in clinical trials for its potential use in treating advanced and metastatic solid tumors. The main goal of this medication is to assess its safety and how well it is tolerated by patients, as well as to evaluate its effectiveness in shrinking tumors. At the molecular level, DS-3939a works by targeting specific pathways that cancer cells use to grow and spread, although the exact mechanism is still under investigation. It falls under the category of experimental cancer therapies, as it is not yet approved for general medical use.

Investigated diseases

Metastatic Solid Tumor
Metastatic solid tumors are cancers that have spread from their original site to other parts of the body. This process, known as metastasis, involves cancer cells breaking away from the primary tumor and traveling through the bloodstream or lymphatic system. Once these cells reach a new location, they can form new tumors. The progression of metastatic solid tumors can vary depending on the type of cancer and the organs affected. These tumors can disrupt the function of the organs they invade, leading to a range of symptoms. The growth and spread of these tumors can be unpredictable and may vary in speed.
Advanced Solid Tumor
Advanced solid tumors refer to cancers that have grown significantly and may have spread to nearby tissues or distant parts of the body. These tumors originate from solid organs or tissues, such as the breast, lung, or colon. As they progress, they can invade surrounding tissues and organs, causing damage and affecting their function. The growth of advanced solid tumors can lead to the formation of masses that may be felt or seen. The progression can be influenced by the type of cancer and its location. Advanced solid tumors often require comprehensive management due to their complexity and potential impact on the body.