Study of Dazostinag and Pembrolizumab for Adults with Advanced or Metastatic Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for patients with advanced or metastatic solid tumors. The study involves a medication called TAK-676, also known as dazostinag, which will be tested both on its own and in combination with another drug called pembrolizumab. Pembrolizumab is already used in cancer treatment and is known by the brand name Keytruda. The trial will also explore the use of TAK-676 and pembrolizumab with or without chemotherapy drugs such as fluorouracil, cisplatin, and carboplatin.

The purpose of this study is to determine the safety and tolerability of TAK-676 when given alone or with pembrolizumab in patients with advanced or metastatic solid tumors. The study will be conducted in several phases, starting with a dose escalation phase to find the safest and most effective dose of TAK-676. This will be followed by an expansion phase to further evaluate the treatment in specific groups of patients, including those with certain types of head and neck cancer and colorectal cancer. Throughout the study, patients will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein.

Participants in the trial will be closely monitored for any side effects and how their tumors respond to the treatment. The study aims to gather important information about how TAK-676 works in the body, including how it is absorbed and processed. This information will help researchers understand the potential benefits and risks of using TAK-676 as a treatment for solid tumors. The trial is expected to continue until 2026, providing valuable insights into the effectiveness of this new treatment approach.

1 joining the study

Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

Consent is required to proceed, ensuring understanding of the study’s purpose and procedures.

2 dose escalation phase

In this phase, the focus is on determining the safety and tolerability of increasing doses of dazostinag, either alone or combined with pembrolizumab.

Medications are administered intravenously, meaning they are given directly into a vein.

3 japan safety lead-in

This phase is specific to Japanese participants, assessing the safety of dazostinag with pembrolizumab.

The goal is to ensure the combination is safe for this population.

4 expansion phase

This phase evaluates the safety of dazostinag with pembrolizumab, with or without chemotherapy, in patients with specific types of cancer.

Participants may receive additional medications such as fluorouracil, cisplatin, or carboplatin, also administered intravenously.

5 treatment administration

Medications are given at specified intervals, with the frequency and duration depending on the phase and individual response.

Regular monitoring is conducted to assess the effects and adjust dosages if necessary.

6 monitoring and assessments

Throughout the trial, health is closely monitored through blood tests, imaging, and other assessments to evaluate the treatment’s impact.

Participants may need to provide tumor biopsies at different stages for further analysis.

7 completion of the trial

Upon completing the trial, a final assessment is conducted to gather data on the treatment’s long-term effects.

Participants receive information on their health status and any necessary follow-up care.

Who Can Join the Study?

Patients must be adults, aged 18 years or older. For the Japan safety lead-in, participants must be Japanese living in Japan.
Any significant side effects from previous treatments should have improved to a mild level or returned to normal, except for hair loss, mild nerve damage, and stable hormone-related conditions.
In certain parts of the study, patients must have at least one tumor that can be biopsied and agree to have two biopsies: one before starting the treatment and one during the treatment.
Patients must have at least one measurable tumor according to specific guidelines. In some cases, non-measurable disease is acceptable.
Blood samples for certain tests must be taken through a specific type of catheter. The study drug is usually given through a central line, but a peripheral line is acceptable if separate from the one used for blood collection.
Female patients must either be postmenopausal, surgically sterile, or agree to use two effective methods of birth control or practice true abstinence during the study and for 180 days after the last dose.
Male patients must agree to use effective barrier contraception or practice true abstinence during the study and for 180 days after the last dose.
Patients must provide written consent to participate in the study.
Patients must be able to give informed consent themselves, unless local laws allow someone else to consent on their behalf.
Patients must have a performance status of 0 to 1, which means they are fully active or have some restrictions but can still carry out light work.
Patients must have a life expectancy of more than 12 weeks.
For certain parts of the study, patients must have advanced or metastatic solid tumors with no standard treatment options or cannot tolerate these treatments.
For the expansion phase, specific criteria apply to patients with certain types of cancer, such as SCCHN or CRC, including previous treatments and tumor characteristics.
Patients must have adequate bone marrow, kidney, and liver function, as determined by specific laboratory tests.
Patients must have a heart function measurement (LVEF) greater than 50% as determined by specific tests within four weeks before starting the study drug.

Who Cannot Join the Study?

Patients who have a type of cancer that is not a solid tumor. A solid tumor is a mass of tissue that does not contain liquid areas or cysts.
Patients who are not within the specified age range for the study.
Patients who are not able to safely receive the study medications due to other health conditions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have certain infections or diseases that could interfere with the study.
Patients who have allergies to the study medications or their components.
Patients who have a history of certain heart conditions.
Patients who are unable to follow the study procedures or attend the required visits.

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
Centr Georges Francois Leclerc	Dijon	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Hospital Foch	Suresnes	France
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Uniklinikum Salzburg	Salzburg	Austria
Nik Llk Grvabbdvyb Tattuylxdjump Gyib	Wiener Neustadt	Austria
Cnkimo Lngd Bcqwep	Lyon	France
Bmdgvtik Uukagozzsk Hgdoxxdf Cwberl	Besançon	France
Nbktwylx Itflwmhr Ozesczgue Ifz Modcx Sqbtbnidsbzmvbrmiwyulodphxhe Ioshgghd Bzndabhl	Cracow	Poland
Uaoxpzubne Oj Aetlenf	Edegem	Belgium
Cdinjj Ogxhz Lwgshcy	Lille	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	02.10.2023
Belgium	Not recruiting	02.10.2023
France	Not recruiting	02.10.2023
Poland	Not recruiting	02.10.2023

Trial locations

Investigated drugs:

TAK-676: This is an investigational medication being studied to understand its safety and how well it is tolerated by patients. It is being tested both on its own and in combination with another medication, pembrolizumab, in patients who have advanced or metastatic solid tumors. The goal is to find out the best dose that can be given safely to patients.

Pembrolizumab: This is a medication that helps the immune system fight cancer. It is already used to treat various types of cancer. In this study, it is being combined with TAK-676 to see if the combination is safe and effective for patients with advanced or metastatic solid tumors.

Investigated diseases:

Neoplasm

Solid Neoplasm – Solid neoplasms are abnormal masses of tissue that arise from the uncontrolled growth of cells in solid organs or tissues, such as the breast, lung, or colon. These tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they have the potential to invade nearby tissues and spread to distant sites. The progression of solid neoplasms depends on their type and location, with malignant tumors often growing more rapidly and aggressively. As they grow, they may cause symptoms by pressing on nearby structures or organs. The behavior of solid neoplasms can vary widely, with some remaining localized and others spreading to form metastases. Understanding the specific characteristics of a solid neoplasm is crucial for determining its potential impact on the body.

Trial ID:

2023-505627-30-00

Protocol code:

TAK-676-1002

NCT ID:

NCT04420884

Trial Phase:

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

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Study of Dazostinag and Pembrolizumab for Adults with Advanced or Metastatic Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?