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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Iwyspyzw Rzyqemfb Do Chgvuh Dg Mluujxaxecx	Montpellier	France
Aqzngcqtqi Pdvxpjvb Hnxcamvt Dr Mafbtoqsj	Marseille	France
Czipsn Lawy Bobbij	Lyon	France
Fzwjbhyth Pchf Lm Ixiunivrpunoz Bypocivej Dcq Hvowgkfm Unjbpogsotfjw Lr Paq	Madrid	Spain
Htioriop Vzzc dwxnraiz	Barcelona	Spain
Hxjwlfmw Ulmvghagqrseov Sboingnfal &hvbwcj Hjnqvvf dv Hkjozmkcvim	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	05.03.2025
France	Recruiting	05.03.2025
Spain	Recruiting	05.03.2025

Trial locations

Investigated drugs:

Ds-3939A

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.

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.

Trial ID:

2023-507937-14-00

Protocol code:

DS3939-077

NCT ID:

NCT05875168

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?