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RecruitingPHASE1INTERVENTIONAL

Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

This study is testing a new way to treat advanced pancreatic cancer in patients who have a specific gene change called KRAS G12C. It combines a focused drug called sotorasib, taken as a tablet, with standard chemotherapy. This is an early-stage study (Phase 1) that aims to find out how safe and well patients tolerate this new combination. Researchers want to see if these treatments can work together effectively. The study is taking place in hospitals in Spain and France and will recruit a small number of patients (6 to 15) to help understand the best way to use these medications together.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Enrolment target
15
Start
08 Aug 2025
Estimated completion
08 Aug 2030

What is this study about?

This research study is for people with advanced pancreatic cancer that has a specific genetic change, known as a KRAS G12C mutation. This mutation means the cancer cells have a particular switch that helps them grow. The study is testing a new approach which combines a targeted medicine called sotorasib with standard chemotherapy.

Sotorasib is a type of drug designed to specifically block the effects of the KRAS G12C mutation, which is often found in these cancer cells. By combining it with chemotherapy, doctors hope to find a more effective way to fight the cancer. This is an early-stage study, called Phase 1, which means the main aim is to carefully check the safety and how well patients tolerate the new combination, rather than to see how effective it is at treating the disease in a large group of people.

The study involves a small number of patients, between 6 and 15, and is taking place in hospitals in Spain and France. The information gathered from this study will be very important for guiding future research into better treatments for pancreatic cancer.

Key takeaways

  • This study is for advanced pancreatic cancer with a specific KRAS G12C gene change.
  • It combines sotorasib (a targeted drug) with standard chemotherapy.
  • It's an early-stage (Phase 1) study focused on safety and tolerability.
  • Only a small number of patients (6-15) will be enrolled.
  • Patients must be over 18 and have not received prior chemotherapy for their advanced cancer.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be 18 years or older and have been diagnosed with advanced pancreatic cancer that has not been treated before with chemotherapy. Importantly, your cancer must also have a specific genetic change called KRAS G12C mutation, which will be found through a special test. Doctors need to be able to measure your cancer, and you should be generally well enough to take part, as decided by a doctor, with an estimated life expectancy of more than three months.

There are also specific blood test results needed to make sure your body organs, like your liver and kidneys, are working well enough for you to safely receive the study treatments. Both men and women can take part. If you are able to have children, you would need to use effective birth control during and for a period after the study to prevent pregnancy.

You would not be able to join if you have already had chemotherapy for your pancreatic cancer, or if your health isn't considered strong enough for the treatments. The research team will review all specific medical conditions and test results to decide if this study is right 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.

  1. Are you 18 years old or older?
  2. Do you have advanced pancreatic cancer with a KRAS G12C gene change?
  3. Have you *not* had chemotherapy for your advanced pancreatic cancer yet?
  4. Are you generally well enough, as determined by a doctor?
  5. Are you able to use effective birth control if applicable?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have a 'screening period' where tests are done to make sure you're suitable. Once you're approved, you'll start the 'treatment period'. You'll be given sotorasib as a tablet to take once a day for 28 days (4 weeks) at a dose of 960 mg, along with either gemcitabine plus nab-paclitaxel, or modified FOLFIRINOX chemotherapy, as chosen by your doctor. You'll have regular visits to the hospital for your chemotherapy, check-ups, and to see how you're responding to the treatment.

During the study, doctors and nurses will closely monitor you for any side effects and how your body handles the medication. After your treatment ends, there will be follow-up periods to keep an eye on your health and any effects of the treatment, both for safety and for a longer time to see how you're doing. You might need to stop treatment if your cancer gets worse, if you can't tolerate the side effects, or if you decide you no longer want to participate.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, as you'd be among the first to receive this new combination treatment for your specific type of cancer. It could potentially help researchers learn more about how to treat advanced pancreatic cancer. However, this is an early-stage study primarily focused on safety, and it's not guaranteed that you will personally benefit from the treatment. There are also potential risks, as sotorasib and chemotherapy can cause side effects. The study team will carefully monitor you for these, but side effects can range from mild to serious. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

  • Sainte Catherine - Institut Avignon Provence
    Verified postcode
    Avignon, France· Not yet recruiting
  • Chu Besançon - Hôpital Jean Minjoz
    Verified postcode
    Besançon, France· Not yet recruiting
  • Chu Brest - Hôpital Morvan
    Verified postcode
    Brest, France· Not yet recruiting
  • Chu de Lille - Claude Huriez
    Verified postcode
    Lille, France· Not yet recruiting
  • Hôpital Léon Berard
    Verified postcode
    Lyon, France· Not yet recruiting
  • Chu Bordeaux - Hôpital Haut Lévêque
    Verified postcode
    Pessac, France· Not yet recruiting
  • Chu Poitiers
    Verified postcode
    Poitiers, France· Not yet recruiting
  • Chu Reims - Hôpital Robert Debré
    Verified postcode
    Reims, France· Not yet recruiting
  • Chu Toulouse
    Verified postcode
    Toulouse, France· Not yet recruiting
  • Hôpital Paul-Brousse
    Verified postcode
    Villejuif, France· Not yet recruiting
  • Hospital Universitario Miguel Servet
    Verified postcode
    Zaragoza, Spain· Recruiting
  • Hospital Clínic
    Verified postcode
    Barcelona, Spain· Recruiting

Common questions

What is the main goal of this study?

The main goal is to check the safety and how well patients tolerate a new combination of sotorasib with standard chemotherapy for a specific type of pancreatic cancer.

What is KRAS G12C mutation?

It's a specific genetic change found in some cancer cells, which is targeted by the drug sotorasib.

How is sotorasib given?

Sotorasib is given as a tablet, taken once a day for 4 weeks (28 days).

How long will I be in the study?

The study includes a screening period, a treatment period, and follow-up periods for safety and long-term health monitoring.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your ongoing medical care.

How to find out more

Grupo de Tratamiento de los Tumores Digestivos

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 "Sotorasib Combined With First-line Chemotherapy for Advanced…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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