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RecruitingPHASE1, PHASE2INTERVENTIONAL

Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies

This research study, called a Phase 1/2 trial, is looking into a new medicine named S241656. It's for adults with advanced cancers such as non-small cell lung cancer, bowel cancer, pancreatic cancer, and other solid tumours that have specific genetic changes called 'RAS' or 'RAF' mutations. The main goals are to find out if S241656 is safe, how well people can tolerate it, and what the best dose is. This new medicine might be given on its own or together with other cancer drugs. Patients will take S241656 by mouth every day in 28-day cycles until their cancer gets worse, side effects are too much, or they decide to stop the study.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Institut de Recherches Internationales Servier
Enrolment target
554
Start
18 Apr 2023
Estimated completion
01 Jun 2028
Non-small Cell Lung CancerHistiocytic NeoplasmHistiocytosisBRAF Gene MutationBRAF V600EBRAF V600 MutationBRAF Mutation-Related TumorsBRAFMetastatic Lung Non-Small Cell CarcinomaMetastatic Lung CancerRecurrent Lung CancerRecurrent Lung Non-Small Cell CarcinomaNSCLCSolid TumorSolid CarcinomaKRAS G12DKRAS G12VKRAS Mutation-Related TumorsNRAS Gene MutationThyroid CancerThyroid CarcinomaColorectal CancerColorectal CarcinomaRecurrent Histiocytic and Dendritic Cell NeoplasmBrain MetastasesRecurrent NSCLCKRAS G13CAcquired Resistance to KRAS G12C InhibitorKRAS G12AKRAS G12FKRAS G12RKRAS G13D

What is this study about?

This study is about a new medicine called S241656, which researchers hope could help people with certain advanced cancers. These include types of lung cancer, bowel cancer, pancreatic cancer, and other solid tumours. The study is particularly focused on cancers that have specific genetic changes, often called 'RAS' or 'RAF' mutations. These mutations are like tiny changes in the cancer cells' DNA that can make the cancer grow.

This is a 'Phase 1/2' trial, which means it has two main parts. In Phase 1, the aim is to find a safe dose of S241656 and understand any side effects. In Phase 2, once a safe dose is found, more people will join to see how well the treatment works against their cancer. Researchers will give S241656 by itself or combine it with other medicines that are already used to treat cancer. This helps them learn if the new medicine is effective when used alone or as part of a combination treatment.

Participants in the study will take the medicine as a tablet by mouth every day in periods called 'cycles,' which last 28 days. This continues as long as the treatment is helping, side effects are manageable, and they wish to stay in the study. The study aims to gather important information about S241656 to see if it can become a new treatment option for people living with these challenging cancers.

Key takeaways

  • Tests a new drug S241656 for specific advanced cancers.
  • Targets cancers with 'RAS' or 'RAF' genetic changes.
  • Seeks to find a safe dose and check effectiveness.
  • Medicine is taken as a tablet by mouth.
  • Involves regular hospital visits and monitoring.
  • Participating is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is for adults aged 18 or older who have advanced cancer that has come back or spread, and where their cancer cells have specific genetic changes (called RAS or RAF mutations). You would need to be well enough to take part and expected to live for at least 12 more weeks.

You would also need to have recovered from any serious side effects from previous cancer treatments. The specific type of cancer you have, such as certain types of lung, bowel, or pancreatic cancer, and the exact genetic changes in your cancer, will determine which part of the study you might be suitable for. There are different groups within the study for different cancer types and mutations.

However, you cannot join if you have a known allergy to S241656 or any other medicines given in the study. Also, if your cancer has a specific 'MEK1/2' genetic change, you would not be able to take part.

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.

  1. Are you an adult aged 18 or older?
  2. Do you have advanced cancer that has come back or spread?
  3. Has your doctor confirmed your cancer has specific 'RAS' or 'RAF' genetic changes?
  4. Are you generally well enough to take part and have recovered from past treatments?
  5. Do you not have an allergy to the study drug or other related treatments?
  6. Is your cancer type included in this study (e.g., certain lung, bowel, pancreatic cancers)?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking a new medicine called S241656, which comes as a tablet you swallow. You'll take this medicine every day in cycles that last 28 days. This treatment continues until your cancer gets worse, any side effects become too difficult, or you decide to leave the study.

Throughout the study, you'll have regular hospital visits. These visits will involve various tests, such as blood tests, scans, and possibly other checks, so the doctors can monitor your health, how well the treatment is working, and if you have any side effects. The exact number of visits and tests will be explained by the study team. You have the right to leave the study at any time.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new, experimental treatment before it's widely available, which could potentially help control your cancer. However, as with any new medicine, there's a possibility of side effects, and it's not guaranteed that S241656 will be effective for your cancer. The research team will carefully monitor your health and any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

  • Banner Health- MD Anderson Cancer Center
    Verified postcode
    Gilbert, United States· Recruiting
  • The Angeles clinic - A cedars SINAI AFFILIATE
    Verified postcode
    Los Angeles, United States· Recruiting
  • USC Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of California, San Francisco (UCSF)
    Verified postcode
    San Francisco, United States· Recruiting
  • University of Colorado - Aurora Cancer Center
    Verified postcode
    Aurora, United States· Not yet recruiting
  • Yale University School of Medicine - Yale Cancer Center
    Verified postcode
    New Haven, United States· Recruiting
  • Georgetown University Lombardi Cancer Center
    Verified postcode
    Washington D.C., United States· Not yet recruiting
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • South Texas Accelerated Research Therapeutics (START) Midwest
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Masonic Cancer Center University of Minnesota
    Verified postcode
    Minneapolis, United States· Recruiting
  • Washington University
    Verified postcode
    St Louis, United States· Recruiting
  • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
    Verified postcode
    New York, United States· Recruiting

Common questions

What is a 'RAS/MAPK Mutation'?

These are changes in the genes of cancer cells that can make them grow quicker. This study is for people whose cancer has these specific changes.

What does 'Phase 1/2' mean?

It means the study is in early stages. Phase 1 finds a safe dose and checks for side effects, while Phase 2 then checks how well the treatment works in more people.

How is S241656 given?

It's given as a tablet that you take by mouth every day. The treatment comes in cycles, usually lasting 28 days each.

Can I still have other cancer treatments?

S241656 might be given alone or with other standard cancer medicines, depending on the study group. The doctors will tell you what's allowed.

What if I feel unwell during the study?

You will be closely monitored, and you should always tell the study team about any side effects or concerns you have right away.

How to find out more

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department

scientificinformation@servier.com +33 1 55 72 60 00 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Po…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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