All studies
Active not recruitingPHASE1INTERVENTIONAL

A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors

This study is looking at a new drug called KIN-2787, which may be given on its own or together with another drug called binimetinib. It’s for adults who have advanced solid tumours with specific genetic changes, known as BRAF and/or NRAS mutations. The main goal is to check how safe these treatments are, whether your body can cope with them, and if they start to shrink the cancer. This is a Phase 1 study, which means it’s one of the first times these drugs are being tested in people. Researchers will also be looking for the best dose to use in future studies. The study includes different types of cancer, such as lung cancer and melanoma, that have these particular genetic changes.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Pierre Fabre Medicament
Enrolment target
400
Start
04 Aug 2021
Estimated completion
30 Mar 2029

What is this study about?

This study is investigating a new medication called KIN-2787. It's being tested in adults who have advanced solid tumours, which are cancers that form a lump or mass and have spread or are difficult to treat. Specifically, this study is for people whose cancer cells have certain genetic changes, called BRAF and/or NRAS mutations. These mutations can sometimes help cancer grow, and KIN-2787 is designed to target them. The study aims to understand how safe KIN-2787 is, how well people tolerate it, and if it can shrink the cancer.

This is a 'Phase 1' study, which is an early stage of clinical research. In this phase, doctors are carefully looking for the right dose of KIN-2787 and checking for any side effects. They may give KIN-2787 on its own or combine it with another existing cancer drug called binimetinib. Combining drugs can sometimes be more effective. The study will also measure how your body processes the drug.

Researchers hope that KIN-2787, alone or with binimetinib, could offer a new treatment option for people with these specific types of cancer, including certain lung cancers and melanoma. By understanding how the drug works and what dose is best, they can then plan bigger studies to see if it can become a standard treatment in the future.

Key takeaways

  • Targets advanced solid tumours with specific BRAF and/or NRAS genetic changes.
  • Tests a new medicine, KIN-2787, alone or with binimetinib, to assess safety and effectiveness.
  • This is an early-stage (Phase 1) study focused on finding the right dose and understanding side effects.
  • Requires regular clinic visits, blood tests, and scans to monitor health and treatment response.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult with an advanced solid tumour that has spread or is difficult to treat. Your cancer must have specific genetic changes called BRAF Class I, Class II, Class III, or, if you have melanoma, an NRAS mutation. These changes must have been found in a previous genetic test of your tumour.

You also need to be well enough to take part, meaning you can swallow and digest medicines by mouth, and your organs (like your liver and kidneys) are working well. Your doctor will check this, along with how active you are in your daily life. The cancer must also be measurable, meaning doctors can see and track its size.

There are some reasons why you might not be able to join. For example, if you've recently had surgery or radiotherapy for your cancer (though some people with brain tumours might still be eligible). You can't have had certain other targeted cancer treatments if you're joining the second part of the study. You also wouldn't be able to join if you have certain gut problems, an active serious infection (including COVID-19), or if you are pregnant or breastfeeding, or have another active cancer that has been treated in the past three years.

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 over?
  2. Do you have an advanced solid tumour (cancer that has spread or is hard to treat)?
  3. Has a genetic test of your cancer shown specific BRAF or NRAS mutations?
  4. Are you able to swallow tablets?
  5. Are you generally well enough for daily activities? (Your doctor will check this.)
  6. Are you not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be taking a study medicine, KIN-2787, which comes as a tablet that you swallow. Depending on which part of the study you are in, you might take KIN-2787 alone or together with another tablet, binimetinib. You will have regular visits to the clinic for checks and assessments, which will include blood tests, scans to check your cancer, and discussions about how you are feeling and any side effects. The visits will be more frequent at the beginning of the study. The total duration of your participation will depend on how you respond to the treatment and should be discussed with the study team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new drug helps to slow down or shrink your cancer, and it could contribute to scientific knowledge that helps future patients. However, there's no guarantee the drug will work for you, and like all medicines, KIN-2787 could cause side effects, some of which might be serious. The study team will carefully monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

  • The Angeles Clinic
    Verified postcode
    Los Angeles, United States
  • UCLA
    Verified postcode
    Los Angeles, United States
  • University of California San Diego, Moores Cancer Center
    Verified postcode
    San Diego, United States
  • University of California San Francisco
    Verified postcode
    San Francisco, United States
  • Stanford Cancer Center
    Verified postcode
    Stanford, United States
  • Sarah Cannon Research Institute Denver
    Verified postcode
    Denver, United States
  • Mayo Clinic - Florida
    Verified postcode
    Jacksonville, United States
  • Sarah Cannon Research Institute - Florida Cancer Specialists
    Verified postcode
    Orlando, United States
  • Mayo Clinic - Rochester
    Verified postcode
    Rochester, United States
  • Atlantic Health
    Verified postcode
    Morristown, United States
  • Rutgers Cancer Institute of New Jersey
    Verified postcode
    New Brunswick, United States
  • NYU Langone
    Verified postcode
    New York, United States

Common questions

What kind of cancer is this study for?

This study is for adults with advanced solid tumours (cancers that form a mass) that have specific genetic changes called BRAF and/or NRAS mutations. This includes certain types of lung cancer and melanoma.

What is KIN-2787?

KIN-2787 is a new medicine being tested. It's designed to target specific genetic changes (mutations) in cancer cells that can help the cancer grow.

What does 'Phase 1' mean?

Phase 1 is an early stage of research where doctors are carefully looking at how safe a new drug is, if people can tolerate it, and what the best dose is, often for the first time in humans.

Will I get KIN-2787 or a placebo (dummy drug)?

In this study, you will receive either KIN-2787 alone or KIN-2787 with binimetinib. There is no placebo in this trial.

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

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect the medical care you receive.

How to find out more

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

Discussion

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