Not recruiting

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

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

8 criteria

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 trial?

3 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Leon Berard
Lyon, France
Verified
Institut Gustave Roussy
Villejuif, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

GEN1042 – This medication is administered through intravenous infusion and is currently being studied in clinical trials for its potential use in treating metastatic solid malignant tumors. It is in the early stages of research, specifically in Phase 1 and Phase 2 trials, to assess its safety and effectiveness when combined with radiotherapy and possibly pembrolizumab. The main therapeutic indication for GEN1042 is to treat metastatic solid tumors by enhancing the immune system's response to cancer cells. At the molecular level, GEN1042 works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells more effectively. It is classified as an immunotherapy agent, which is a type of treatment that uses the body's immune system to fight cancer.

Investigated diseases

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.