Study on the Safety and Effectiveness of Tecaginlimab and Pembrolizumab with Radiotherapy for Patients with Metastatic Solid Tumors

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What is this study about?

This clinical trial is focused on studying treatments for metastatic solid tumors, which are cancers that have spread from their original site to other parts of the body. The study is exploring the use of a combination of treatments, including pembrolizumab and DuoBody®-CD40x4-1BB (also known as tecaginlimab), along with radiotherapy. Pembrolizumab is a type of medication known as an immunotherapy, which helps the immune system fight cancer. DuoBody®-CD40x4-1BB is another form of immunotherapy that targets specific proteins to help the immune system attack cancer cells more effectively.

The purpose of this study is to evaluate the safety and effectiveness of these treatment combinations. The study is divided into two parts. In the first part, researchers aim to find the best dose of DuoBody®-CD40x4-1BB when used with radiotherapy, with or without pembrolizumab. In the second part, the study will assess how well these treatments work together in shrinking tumors that have not been directly treated with radiation. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, participants will be monitored for any side effects and how their cancer responds to the treatment. The study will also look at how long the treatment effects last and the overall survival of participants. This trial is expected to continue until December 2025, providing valuable information on the potential benefits of combining these therapies for treating metastatic solid tumors.

1 joining the trial

Upon joining the trial, participants must have a confirmed diagnosis of a metastatic solid tumor that is not located in the central nervous system. The tumor must be measurable according to specific criteria.

Participants must be at least 18 years old, have a life expectancy of more than three months, and meet certain health criteria, including normal or adequate liver, renal, cardiac, and bone marrow function.

2 treatment phase 1

In the first phase of treatment, the main goal is to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of the medication GEN1042 when used in combination with radiotherapy, with or without the medication pembrolizumab.

Participants will receive GEN1042 and pembrolizumab through intravenous infusion. The specific dosage and frequency will be determined based on the participant’s response and tolerance to the treatment.

3 treatment phase 2

In the second phase, the focus is on evaluating the response of the tumor to the treatment, particularly in areas that are not directly targeted by radiotherapy. This is known as the abscopal response.

Participants will continue to receive GEN1042 and pembrolizumab as in phase 1, with adjustments made as necessary based on the results from the first phase.

4 monitoring and assessment

Throughout the trial, participants will be closely monitored for any side effects or adverse reactions to the treatment. This includes regular assessments of the tumor’s response to the therapy using imaging techniques.

The trial will also evaluate various outcomes such as the overall survival rate, progression-free survival, and the duration of the response to the treatment.

5 end of trial

The trial is expected to conclude by December 2025. At the end of the trial, a comprehensive analysis of the data collected will be conducted to determine the safety and effectiveness of the treatment combinations.

Who Can Join the Study?

Participants must have a type of cancer called a metastatic solid tumor, which means the cancer has spread to other parts of the body and is not in the brain or spinal cord.
Participants must be at least 18 years old.
Participants must sign a document called an informed consent before any tests or procedures for the study begin. This document explains the study and confirms that the participant agrees to take part.
Participants must have a cancer that can be measured using a specific method called RECIST v1.1, which is a set of rules to measure how the cancer responds to treatment.
Participants must have a life expectancy of more than 3 months.
Participants must be eligible for a treatment option called palliative SBRT, which is a type of radiation therapy used to relieve symptoms and improve quality of life.
Participants must have an ECOG performance status of 0-1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
Participants must have normal or adequate function of the liver, kidneys, heart, and bone marrow, which are important organs and tissues in the body.

Who Cannot Join the Study?

Patients with certain types of cancer that have spread to other parts of the body, known as metastatic solid malignant tumors, cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country	Status
Cttuic Lubw Bfqlze	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.10.2022

Trial locations

Investigated drugs:

GEN1042 is an investigational medication being studied for its potential to treat metastatic solid tumors. It is being tested in combination with other therapies to determine its safety and effectiveness. The trial aims to find the most suitable dose of GEN1042 when used with radiotherapy, with or without another medication.

Pembrolizumab is a medication that helps the immune system detect and fight cancer cells. It is being used in this trial to see if it can enhance the effects of GEN1042 and radiotherapy in treating metastatic solid tumors.

Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, it is combined with GEN1042, with or without pembrolizumab, to evaluate its effectiveness in treating metastatic solid tumors.

Investigated diseases:

Neoplasm malignant

Metastatic Solid Malignant Tumors – These are cancers that have spread from their original site to other parts of the body, forming new tumors in organs or tissues. The progression involves cancer cells breaking away from the primary tumor, traveling through the bloodstream or lymphatic system, and establishing new tumors in distant organs. This spread can lead to a variety of symptoms depending on the location of the metastases. The growth of these tumors can disrupt the normal function of affected organs, leading to further complications. The rate of progression and the specific organs affected can vary widely between individuals.

Trial ID:

2023-508529-29-00

Protocol code:

GCT1042-02

NCT ID:

NCT05491317

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Tecaginlimab and Pembrolizumab with Radiotherapy for Patients with Metastatic Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?