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RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

This research study is investigating a new medication, INCB161734, for people with advanced or metastatic solid tumours. These are cancers that have spread or are difficult to treat, and they all have a specific change in their genes called a KRAS G12D mutation. The main aim of the study is to find out if INCB161734 is safe and if people can tolerate it well. The researchers will be testing INCB161734 on its own and also in combination with other existing cancer treatments. This is an early-stage study (Phase 1), which means it's one of the first times this new drug is being tested in humans to understand its basic effects.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Incyte Corporation
Enrolment target
710
Start
04 Jan 2024
Estimated completion
01 Jan 2027

What is this study about?

This study is about exploring a new way to treat certain advanced cancers. These are solid tumours, which means they form a lump, and they have either spread to other parts of the body (metastatic) or are hard to remove with surgery (locally advanced). A key feature of the cancers in this study is a specific change in their genes, called a KRAS G12D mutation. This genetic change can sometimes make cancer harder to treat with standard therapies. The trial is investigating a new drug, INCB161734, to see if it can help.

Researchers want to understand two main things: how safe the new drug is, and whether people can tolerate taking it without too many side effects. They will be looking at this when INCB161734 is given by itself, and also when it's combined with other commonly used cancer treatments like Cetuximab, Retifanlimab, GEMNabP, mFOLFIRINOX, FOLFOX, or FOLFIRI. This is an early-stage study, known as Phase 1, so the main focus is on safety and finding the right dose.

The hope is that if INCB161734 proves to be safe and manageable, it could potentially offer a new treatment option for people whose cancers have this specific KRAS G12D mutation, especially if other treatments haven't worked or aren't suitable. It's a step towards finding more targeted ways to fight cancer.

Key takeaways

  • Investigates a new drug (INCB161734) for advanced solid tumours.
  • Specifically targets cancers with a KRAS G12D genetic mutation.
  • Aims to check the safety and tolerability of the drug (Phase 1 study).
  • May involve the new drug alone or combined with other cancer treatments.
  • Suitable for people who have tried other treatments or have limited options.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a solid tumour that is advanced or has spread. Your cancer must also have a specific genetic change called a KRAS G12D mutation. In many cases, you would have already tried other standard cancer treatments, or those treatments might not be suitable for you. You also need to be generally well enough to take part, meaning you can carry out most of your daily activities without much difficulty.

There are certain reasons why someone might not be able to join. For example, if you've already had a treatment designed specifically for KRAS G12D mutations, or if you've had another type of cancer within the last year that could interfere with the study. You also wouldn't be able to join if you've had an organ transplant, have a serious uncontrolled medical problem, certain heart issues, or if your organs like your liver or kidneys aren't working well enough. The medical team will check all these details carefully.

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 an advanced or metastatic solid tumour?
  3. Does your cancer have a KRAS G12D gene mutation?
  4. Have you already tried standard treatments, or are they not suitable for you?
  5. Are you generally well enough to go about your daily activities?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the new study drug, INCB161734, either on its own or in combination with other cancer treatments. This will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These assessments help the doctors understand how safe the treatment is and if it's working. The exact number of visits and the duration of your participation will depend on the specific part of the study you are in and how you respond to the treatment. You will receive detailed information about your schedule if you join.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option for your cancer, especially if standard therapies haven't been effective or aren't suitable. However, as with any new medication, there are potential risks and side effects. These will be fully explained to you before you decide to join. It's important to remember that this is an early-stage study, so the long-term effects of the drug are not yet fully known. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (37)

  • Mayo Clinic Hospital
    Verified postcode
    Phoenix, United States· Recruiting
  • Stanford University
    Verified postcode
    Palo Alto, United States· Recruiting
  • UCLA Healthcare Hematology-Oncology
    Verified postcode
    Santa Monica, United States· Recruiting
  • Sarah Cannon Research Institue At Healthone
    Verified postcode
    Denver, United States· Recruiting
  • Mayo Clinic Florida
    Verified postcode
    Jacksonville, United States· Withdrawn
  • Florida Cancer Specialists
    Verified postcode
    Sarasota, United States· Recruiting
  • Florida Cancer Specialists
    Verified postcode
    Sarasota, United States· Withdrawn
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
    Verified postcode
    Baltimore, United States· Recruiting
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • Mayo Clinic
    Verified postcode
    Rochester, United States· Withdrawn
  • Hackensack University Medical Center
    Verified postcode
    Hackensack, United States· Recruiting
  • Weill Cornell Medicine
    Verified postcode
    New York, United States· Recruiting

Common questions

What is a KRAS G12D mutation?

It's a specific change in the genes of your cancer cells. Some cancers have this change, and researchers are looking for treatments that can specifically target it.

What does 'Phase 1' mean for a clinical trial?

Phase 1 is the first stage where a new drug is tested in humans. The main goals are to check if it's safe, find the right dose, and understand how the body handles it.

Will I definitely receive the new drug INCB161734?

Yes, if you qualify for this study, you will receive INCB161734, either by itself or along with other standard cancer treatments.

What if my cancer isn't advanced or hasn't spread?

This study is specifically for people whose solid tumours are advanced or have spread (metastatic). If your cancer is in an earlier stage, you likely wouldn't be eligible for this particular study.

Can I stop participating in the study if I want to?

Yes, you have the right to leave the study at any time, for any reason. Your decision will not affect your 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 INCB161734 in Participants With Advanced…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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