Study of SAR445877 and Cetuximab for Adults with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying advanced forms of solid tumors, which are a type of cancer that forms in solid organs or tissues. The study is testing a new treatment called SAR445877, which is being evaluated for its safety and effectiveness. This treatment is given as an infusion, meaning it is administered directly into the bloodstream through a vein. The trial will also explore the use of Erbitux, another medication, in combination with SAR445877. Erbitux is a solution for infusion that contains the active substance cetuximab.

The purpose of the study is to determine the best dose of SAR445877 and to understand how well it works when used alone or with other cancer treatments. The study will be conducted in two parts. The first part will focus on finding the maximum dose that can be safely given to participants. The second part will look at how effective the treatment is at the recommended dose. Participants in the study will have advanced cancers, such as colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and gastric cancer, among others.

Throughout the study, researchers will monitor participants for any side effects and measure how the cancer responds to the treatment. The study will also assess the presence of any anti-drug antibodies, which are proteins made by the immune system that might affect how well the treatment works. The trial aims to provide valuable information about the potential benefits and risks of SAR445877 for people with advanced solid tumors.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be required to provide informed consent, which means you agree to participate after understanding all the information provided.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This may include a review of your medical history, physical examination, and laboratory tests to ensure you meet the study criteria.

3 treatment phase – dose escalation

During the dose escalation phase, you will receive the investigational medication SAR445877 as a monotherapy or in combination with other therapies. The medication is administered through an intravenous infusion, which means it is given directly into your vein.

The goal of this phase is to determine the maximum tolerated dose and to assess the safety and tolerability of the medication. You will be closely monitored for any side effects or adverse reactions.

4 treatment phase – dose expansion

In the dose expansion phase, you will continue to receive SAR445877 at the recommended dose determined in the previous phase. This phase aims to evaluate the medication’s effectiveness in treating your condition.

You will undergo regular assessments to monitor your response to the treatment and any potential side effects.

5 regular monitoring

Throughout the trial, you will have regular visits to the study site for monitoring. This includes physical exams, blood tests, and imaging studies to track your health and the progress of your condition.

The frequency of these visits will be determined by the study protocol and your specific treatment plan.

6 end of treatment

At the end of the treatment phase, a final assessment will be conducted to evaluate your overall response to the medication and any long-term effects.

You will be provided with information on any follow-up care or additional treatments that may be necessary.

Who Can Join the Study?

Participants must have a type of cancer called a solid tumor that cannot be removed by surgery or has spread to other parts of the body.
Participants must have a cancer diagnosis confirmed by a doctor through tests called histology or cytology.
Participants must have at least one tumor that can be measured by doctors using specific criteria.
Participants must be able to provide written consent to join the study.
Participants with a type of colorectal cancer that has specific genetic changes called RAS-mutant or BRAF-mutant are eligible.
Participants with a type of lung cancer called metastatic non-small cell lung cancer (NSCLC) are eligible.
Participants with a type of liver cancer called hepatocellular carcinoma (HCC) are eligible.
Participants with a type of stomach cancer or cancer at the junction of the stomach and esophagus are eligible.
Participants must have their cancer’s MSI or MMR status known or tested locally. They must have a specific type called non-MSI-H or proficient MMR (pMMR).
Participants with unknown HER2/neu status must have it tested locally. Those with HER2/neu negative are eligible. If positive, they must have shown disease progression on a treatment targeting HER2.
Participants must have a specific score called CPS determined locally for certain cancer types.
Participants must be adults, as both male and female adults are eligible.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to the study drug or similar drugs.
Patients who are currently pregnant or breastfeeding.
Patients with uncontrolled medical conditions that could interfere with the study.
Patients who have received another investigational drug within a certain period before the study.
Patients with active infections that require treatment.
Patients with a history of other cancers, unless they have been in remission for a certain period.
Patients with significant heart problems.
Patients with severe liver or kidney disease.
Patients who are unable to comply with the study procedures.
Patients with a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Netherlands Cancer Institute	Amsterdam	The Netherlands
Ewtplmn Ulrpddoycrze Mdwisjl Cngszsv Rmihkntpu (hveriom Mqw	Rotterdam	The Netherlands
Hfwwcmez Vqna dolwsqww	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	09.10.2023
The Netherlands	Recruiting	09.10.2023

Trial locations

Investigated drugs:

SAR445877 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. The trial is looking at how safe this medication is for people to use and how well it works against cancer. Researchers are also trying to find the best dose to give to patients. This medication can be given by itself or together with other cancer treatments to see if it works better in combination.

Investigated diseases:

Neoplasm

Solid tumor – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a lump or mass. As they progress, solid tumors can invade nearby tissues and organs, potentially disrupting their normal function. They may also spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The growth rate and behavior of solid tumors can vary widely depending on their type and location.

Trial ID:

2023-507141-28-00

Protocol code:

TCD17620

NCT ID:

NCT05584670

Trial Phase:

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

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Study of SAR445877 and Cetuximab for Adults with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?