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This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

Have you been diagnosed with cancer and screened for changes in a gene called BRAF or a gene called NRAS?

If so, then you may be eligible to join a new actively enrolling clinical research study.

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About the study

Kinnate Biopharma Inc. (sponsor) is evaluating the safety and efficacy of an investigational targeted therapy called KIN-2787 (study drug) that may work for some patients who are diagnosed with BRAF mutation-positive cancers or NRAS mutation-positive melanoma. Mutations, or changes, to the BRAF and NRAS genes affect how cells grow and divide. BRAF and NRAS gene mutations are found with genetic testing.

For this study (also called a clinical trial) adult participants will receive daily medicine taken by mouth of the study drug and have been diagnosed with advanced and/or metastatic solid tumors with BRAF or NRAS gene mutations. For more information, visit the National Institutes of Health’s (NIH) ClinicalTrials.gov website: clinicaltrials.gov/ct2/show/NCT04913285.

KN-8701 Study Details

The main goals of this study are to learn:

about the safety of the study drug
about how the body tolerates the study drug
whether a participant’s cancer responds to treatment with the study drug

Estimated Enrollment

155 participants

Phase

Phase 1

Study Part A

The main goals of this part of the study are to learn more about the safety and tolerability of the study drug, either alone or in combination with another cancer drug called binimetinib, and to learn more about which dose or doses of the study drug should be considered for further investigation. The researchers will also look at how each participant’s cancer responds to treatment.
The results of this part of the study will help determine which dosage of the study drug participants will take in Part B.

Study Part B

The main goal of this part of the study is to learn how each participant’s cancer responds to treatment. The researchers will also look at the safety and tolerability of treatment.

Eligibility Criteria

Inclusion Criteria:

Main criteria below. Note: Any additional criteria will be confirmed at the study clinic

Have a metastatic or advanced stage solid tumor.
Have a tumor with a type of BRAF mutation called Class I, Class II, or Class III or melanoma with an NRAS mutation, as determined by genetic testing. One example of a BRAF Class I mutation is called V600E. The type of mutation you have may affect which part(s) of the study you can join.
Be able to take medications by mouth.
Be able to attend study visits and complete study assessments.

Exclusion Criteria:

Main criteria below. Note: Any additional criteria will be confirmed at the study clinic

Have been diagnosed with brain metastases from non-brain tumors. This means cancer started in one part of the body and spread to the brain. However, some people who have had brain metastases successfully treated may be able to join the study.
Have a recent history of certain medical conditions, such as an active uncontrolled infection, that may put the participant at higher risk for side effects.
Be lactating or breastfeeding, or pregnant.

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What Will Happen in This Study

If you are interested in joining this study, you will need to visit a clinical study site. A doctor will explain the study to you. If you agree to join, the doctors and study staff will perform an evaluation to make sure you are eligible.

If you decide to join this study, you will receive treatment until you start a new treatment for your cancer, your cancer progresses, your doctor thinks it would be in your best interest to switch to another cancer treatment, you choose to leave the study, you no longer meet the study requirements, or the study ends.

Full details about the KN-8701 study, study visits, and examinations will be discussed with you before you decide whether you want to join the study.

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Travel Support

The sponsor will cover travel expenses related to the study visits for the participant and one caregiver. Examples of expenses:

Airfare
Hotel
Meals
Parking fees
Childcare, eldercare, and pet care

The clinical study staff will share additional information on travel support if you decide to participate in the study.

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Where to Join

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location

Status

Tacoma, WA, 98405, United States, Northwest Medical Specialties

Inactive

Cleveland, OH, 44106, United States, Cleveland Clinic Foundation

Inactive

O'Fallon, IL, 62269, United States, Decatur Memorial Hospital

Recruiting

Stanford, CA, 94305, United States, Stanford Cancer Center

Recruiting

New York, NY, 10065, United States, Weill Cornell Medicine

Inactive

New York, NY, 10021, United States, Memorial Sloan Kettering Cancer Center

Inactive

Dallas, TX, 75230, United States, Mary Crowley Cancer Research

Inactive

Orlando, FL, 32827, United States, Florida Cancer Specialists (SCRI)

Recruiting

Santa Rosa, CA, 95403, United States, Providence Medical Foundation

Recruiting

See if You are Eligible

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Frequently Asked Questions (FAQs)

What are targeted therapies?

The goal of targeted therapies is to stop cancer cells from growing. They have been used for more than 20 years. They include drugs that take aim at specific parts of cancer cells, such as genes in cancer cells that have changed (mutated). For some cancers, targeted therapies may work better or be better tolerated than other available treatments.

Why should I consider enrolling in this study?

Based on a genetic test ordered by your doctor, your cancer cells may have one or more of the gene changes that this drug targets. Not all doctors know about this investigational targeted therapy, so it is worth having a discussion with them before deciding what to do. KIN-2787 is only available in this study.

Will I automatically be accepted into this clinical study?

No, not until there are additional checks to your recent medical tests and medical history to make sure you can safely join this study. Every study has detailed requirements for enrollment. These are called the eligibility criteria.

How can I check to see if I’m eligible for this study?

You can check if you are potentially eligible for this study by completing a set of screening questions. You can find these on this web page by clicking the “Check Eligibility” button.

Who will cover the costs of participating in this study?

Costs related to the study visits will be covered by the study sponsor, Kinnate Biopharma, including travel costs. For more information about travel support and participation, please email: [email protected]

What if I don’t live near a clinical study site?

The study sponsor, Kinnate Biopharma, can provide complimentary travel service, such as car or airfare, to a clinical study site. For more information about travel support and participation, please email: [email protected].

Where can I learn more?

More information about this and other studies can be found by searching the NIH ClinicalTrials.gov website. You can search for this study by using this number: NCT04913285. For additional information, you can also email [email protected].

What is a Phase 1 study?

When new drugs are being studied as possible treatments for patients with a disease, they are tested in stages, or “phases.” If a drug is successful during Phase 1, it moves to Phase 2. Phase 1 studies are usually conducted with a small number of participants. Researchers may conduct a Phase 1 study to learn more about how a drug (or drug combination) behaves in the body, to find a safe dose, or to test a new formulation of a drug (such as a pill versus an injection). In Phase 1 cancer studies, researchers will also start to look at how well a drug fights cancer.

What does a typical study look like?

A clinical study helps determine the safety and efficacy of new treatments. A research plan or protocol is created that outlines how study participants may receive interventions, which can include investigational medications, devices, or procedures. The study may compare a new medical approach to a standard treatment option that is already available, to a placebo with no active investigational medication, or to no intervention at all. If you decide to participate, the study staff will provide you with more information.

Can I quit the study at any time?

Study participants have the right to stop participating at any time for any reason or no reason at all. The doctor or sponsor also has the right to discontinue a study participant at any time for safety issues or if the participant no longer meets the study requirements.

What personal information is collected about you for the study?

The study staff will collect your personal information. This may include, but is not limited to, this information:

Your name, address, telephone number, and health insurance number where applicable
Your age and sex
Your ethnic and racial background
Lifestyle information
Your health and medical history
Genetic data resulting from testing your biological samples

Who has access to your personal information collected for the study?

All personal information collected for this study will be securely stored in the medical records at the clinical study site. Clinical study site staff, sponsor staff, review boards and ethics committees (that approve and monitor studies), and government agencies may check study records. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify study procedures and/or data.