This trial is shared by:

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.

About the study

Kinnate Biopharma Inc. (sponsor) is testing 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.

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.

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.

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
Moffitt Cancer Center, Tampa, FL, 33647, United States
Inactive
Stanford Cancer Center , Stanford, CA, 94305, United States
Recruiting
Florida Cancer Specialists (SCRI), Orlando, FL, 32827, United States
Recruiting
Nebraska Cancer Specialists, Grand Island, NE, 68803, United States
Recruiting
See if you are eligibile

Frequently Asked Questions (FAQs)