Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

M1774 (oral ATR inhibitor) in Combination with PLX038 (Topo1 inhibitor) with dose expansion cohorts in patients with advanced solid tumors

This is an early-stage research study, called a Phase 1 trial. It aims to find out if combining two new medicines, M1774 and PLX038, is safe for people with advanced cancers that have already been treated with other therapies. The study will also help doctors find the best dose of these medicines to use together. We're looking for adults aged 18 and over, both men and women, with advanced cancer. This includes a specific type of breast cancer called triple-negative breast cancer, and other advanced cancers where a gene called ATM has changed. As it's an early study, the main goal is to check for side effects and how the body handles the drugs, rather than directly treating the cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Institut Curie

Enrolment target

Start

11 Mar 2024

Patients with pretreated metastatic or locally advanced cancer for the dose escalation part and dose expansion cohorts in patients with advanced triple-negative breast cancers and advanced cancers with ATM mutation.

What is this study about?

This research is an early-stage study, often called a Phase 1 trial. This means it's one of the first times these specific medicines, M1774 and PLX038, are being given together to people. The main goal of this type of study isn't to cure cancer, but to carefully check if the combination of these new drugs is safe and whether people can tolerate them. Doctors are also looking to find the best dose to use when these two medicines are given together.

The study involves people who have advanced cancer that has already been treated with other medicines. They are particularly interested in two groups: those with a type of breast cancer called triple-negative breast cancer, and people with other advanced cancers that have a specific change in a gene called ATM. Understanding how these drugs work together in these particular cancers is important for future research.

Finding safe and effective new treatments for cancer is a long process, and studies like this are a vital first step. By taking part, volunteers help doctors learn more about these new medicines. This information is crucial, as it helps determine if the drugs are promising enough to move on to larger studies in the future, which could eventually lead to new treatment options for patients.

Key takeaways

This is an early-stage (Phase 1) study for advanced cancers.
It's testing a new combination of two medicines, M1774 and PLX038.
The main goals are to check safety and find the best dose.
Participants include those with triple-negative breast cancer or cancers with an ATM gene change.
You would receive close medical monitoring and contribute to future cancer treatments.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older. This includes both men and women. To be considered, you will need to have a type of cancer that is considered 'advanced.' This might mean the cancer has spread to other parts of your body (metastatic) or it's a locally advanced cancer that hasn't responded to previous treatments.

Specifically, the study is interested in two main groups of people. One group includes those with advanced triple-negative breast cancer. The other group is for people with advanced cancers that have a change, or 'mutation,' in a gene called ATM. Your doctor will be able to tell you if your cancer fits these descriptions.

Since this is an early study, participants will have already received other treatments for their cancer. The research team will review your medical history carefully to make sure the study is a safe and suitable option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced cancer (metastatic or locally advanced)?
Have you already received other treatments for your cancer?
Do you have triple-negative breast cancer or a cancer with an ATM gene change?
Are you able to visit the clinic frequently for appointments and tests?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would receive the new combination of medicines, M1774 and PLX038. Because it's an early-stage study, you would likely have frequent visits to the hospital or clinic, especially at the beginning. These visits would involve regular check-ups, blood tests, and scans to monitor your health and how your body is reacting to the medicines. The doctors would also be looking closely for any side effects.

The study will first focus on finding the right dose, which means different groups of participants might receive slightly different amounts of the drugs. After the best dose is found, more people will join to further test this dose. The total duration of your participation in the study would depend on how your body responds to the treatment and the study’s protocol, and this would be explained fully before you decide to join. There will be regular follow-up appointments even after you stop receiving the study drugs to monitor your long-term health.

Potential risks and benefits

There are potential benefits to taking part in this study, although they cannot be guaranteed. You would have access to new medicines that are not yet available outside of clinical trials, and your health would be closely monitored by a dedicated medical team. You would also be contributing important information that could help others in the future. However, there are also potential risks involved. The medicines may cause side effects, some of which could be serious or unexpected, as these drugs are still being tested. Your doctor will explain all known and potential risks to you. Remember, joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What does 'Phase 1' mean for this study?

Phase 1 means this is an early study, mainly focused on checking if the new medicines are safe and finding the right dose, rather than directly treating the cancer.

What are M1774 and PLX038?

These are the names of the two new experimental medicines being tested together in this study. They are designed to work against cancer cells in different ways.

What is 'triple-negative breast cancer'?

Triple-negative breast cancer is a specific type of breast cancer that doesn't have certain features (receptors) that are targeted by some common cancer medicines.

What is an 'ATM mutation'?

An ATM mutation is a change in a specific gene called ATM. Some cancers have this change, and researchers believe it might make them respond differently to certain treatments.

Will my cancer be cured in this study?

While we hope to learn more about new treatments, the main goal of this early-stage study is safety and finding the right dose, not a cure. Any direct benefit cannot be guaranteed.