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RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

This research study is investigating an investigational drug called INCB161734. It's being tested with standard chemotherapy for people with pancreatic cancer that has spread (metastatic) and has a particular genetic mutation known as KRAS G12D. This is for patients who haven't received treatment for their advanced cancer before. The main goal is to find out if adding INCB161734 to chemotherapy is more effective than chemotherapy alone, and to ensure it's safe. Some participants will receive the new drug plus chemotherapy, while others will receive chemotherapy plus a placebo (a dummy drug). This helps doctors understand the true effect of INCB161734.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Incyte Corporation
Enrolment target
588
Start
09 Apr 2026
Estimated completion
19 Mar 2029

What is this study about?

This study focuses on a type of cancer that starts in the pancreas, specifically when it has spread to other parts of the body (this is called metastatic pancreatic cancer). Doctors have found that some pancreatic cancers have a specific change in their genes, known as a KRAS G12D mutation. This study is testing a new medicine, INCB161734, alongside the usual chemotherapy treatments for this particular type of cancer. The researchers want to see if combining INCB161734 with chemotherapy works better at treating the cancer and if it’s safe for patients.

Imagine you have a jigsaw puzzle, and one piece is slightly different - that's like the KRAS G12D mutation in cancer cells. This study is trying a new tool (INCB161734) specifically designed to target that different piece, hoping it will help chemotherapy work even better to tackle the cancer. This is a "Phase 3" study, which means it's one of the final steps in testing a new drug. It compares the new treatment combination against the standard chemotherapy to confirm its effectiveness and safety on a larger group of people.

By taking part, you would help doctors understand if this new approach could offer a better way to treat metastatic pancreatic cancer with this specific genetic change. The hopeful outcome is that this new combination could slow down the cancer's growth or shrink it, improving the health and quality of life for people living with this condition.

Key takeaways

  • This study is for advanced pancreatic cancer with a specific genetic change (KRAS G12D).
  • It's testing a new medicine, INCB161734, with standard chemotherapy.
  • Participation involves either the new drug or a dummy pill alongside chemotherapy.
  • It's for people who haven't had treatment for their advanced cancer yet.
  • Regular check-ups, blood tests, and scans will monitor your health.
  • You can leave the study at any time if you change your mind.

Who may be eligible?

To join this study, you would need to have pancreatic cancer that has spread, and tests must show that your cancer has a specific genetic change called a KRAS G12D mutation. This study is for people who have not yet received any treatment for their advanced cancer.

You also need to be generally well enough to take part in a study like this. Doctors will check your overall health and how active you are. Your body's organs, like your liver and kidneys, need to be working properly, which will be checked with blood tests.

There are also reasons why someone might not be able to join. For example, if you've already had treatment with a similar type of drug called a KRAS inhibitor, or if you have an active infection. People with cancer that has spread to the brain and is causing problems would also not be able to participate. Your medical team will go through all the detailed requirements with you to see if this study could be a good fit.

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. Do I have pancreatic cancer that has spread (metastatic)?
  2. Have I had a test that shows my cancer has a KRAS G12D gene change?
  3. Have I *not* yet received any treatment for my advanced pancreatic cancer?
  4. Am I generally well and active enough to take part in a study?
  5. Do I have any serious infections or active cancer spread to my brain?
  6. Have I been treated with a KRAS inhibitor before?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the new medicine (INCB161734) with chemotherapy, or a dummy treatment (placebo) with chemotherapy. You wouldn't know which group you are in, and neither would your doctors, to ensure the results are accurate. You would have regular appointments with the study team for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working against the cancer. You would also need to take the study medication as directed.

The study would involve regular visits to the hospital or clinic for these check-ups and treatments. The exact number of visits and the full duration of your participation would depend on how your treatment is going and how long the study continues to follow participants. The study team will explain the full schedule to you in detail.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could be more effective than standard chemotherapy alone for your specific type of cancer. However, there are also potential risks involved, as all medicines can have side effects. The new drug, INCB161734, might cause new side effects, or make existing side effects from chemotherapy worse. The research team will closely monitor you for any side effects and provide care. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (215)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Investigative Site US058
    Verified postcode
    Birmingham, United States· Not yet recruiting
  • Investigative Site US016
    Verified postcode
    Anchorage, United States· Recruiting
  • Investigative Site US026
    Verified postcode
    Chandler, United States· Not yet recruiting
  • Investigative Site US045
    Verified postcode
    Tucson, United States· Not yet recruiting
  • Investigative Site US051
    Verified postcode
    Duarte, United States· Not yet recruiting
  • Investigative Site US048
    Verified postcode
    Fountain Valley, United States· Not yet recruiting
  • Investigative Site US049
    Verified postcode
    Irvine, United States· Not yet recruiting
  • Investigative Site US054
    Verified postcode
    La Jolla, United States· Not yet recruiting
  • Investigative Site US027
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • Investigative Site US036
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • Investigative Site US034
    Verified postcode
    San Francisco, United States· Not yet recruiting
  • Investigative Site US001
    Verified postcode
    Santa Monica, United States· Not yet recruiting

Common questions

What is a KRAS G12D mutation?

It's a specific change found in the genes of some cancer cells that doctors believe helps the cancer grow. This study focuses on pancreatic cancer with this particular change.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started (the pancreas) to other parts of the body.

Will I get the new drug or a dummy pill?

Participants will be randomly assigned to receive either the new drug (INCB161734) plus chemotherapy or a dummy pill (placebo) plus chemotherapy. You won't know which one you're getting.

What is a 'Phase 3' study?

Phase 3 is one of the final steps in testing a new medicine. It means the drug has already shown promise in earlier studies and is now being compared to standard treatments in a larger group of people to confirm its benefits and safety.

Can I stop participating if I want to?

Yes, you can choose to stop taking part in the study at any time, for any reason, without it affecting your regular medical care.

How to find out more

Incyte Corporation Call Center (US)

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 "A Study to Evaluate Chemotherapy With or Without INCB161734 …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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