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A Phase 1/1b Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants with BRAF and/or NRAS Mutation-positive Solid Tumors

Clinical Trial Details

This clinical trial is for adults who have advanced cancer that may have spread to other parts of their body and is known to have a BRAF mutation or a NRAS mutation.
   
The purpose of this study is to evaluate whether an experimental study drug called KIN-2787 by itself or in combination with a study drug called binimetinib is safe and tolerated when given to adults with advanced cancers. The study will also evaluate whether KIN-2787 can slow down or stop a tumor from growing.
   
KIN-2787 belongs to a class of anti-cancer drugs called BRAF inhibitors. BRAF is a gene inside cells that helps control cell growth, and cancer can result when there are mutations in this gene. BRAF mutations are found in melanoma, non-small cell lung cancer, colorectal cancer, and thyroid cancer, but have been detected in other cancers as well.

Experimental means that KIN-2787 has not yet been approved by the U.S. Food and Drug Administration (FDA).

Binimetinib is a MEK inhibitor that is FDA approved in combination with a BRAF inhibitor for treatment of certain melanomas, however, it is not FDA approved in combination with KIN-2787.
   
The study is divided into 2 parts: Part A and Part B. The study doctor will tell participants which part they are in. The first part of the study (Part A) will evaluate the safety of different doses of KIN-2787 and determine which dose should be used in the next part of the study (Part B).

Part A has two study treatment groups. One group will receive study treatment with study drug KIN-2787 (Part A1) and the other group will receive study treatment with study drug KIN-2787 plus binimetinib (Part A2).

Part B will evaluate whether the selected dose of KIN-2787 from Part A1 continues to be safe in a larger group of people. Part B will also evaluate whether KIN-2787 can slow down or stop a tumor from growing.

Participants will take the study drug(s) in tablet form by mouth every day according to the directions provided by their study doctor and return to the clinic for study visits at various times during their study treatment cycles. Each study treatment cycle lasts 28 days. Participants will continue study treatment cycles until the study doctor recommends stopping the study drug or the participant’s cancer gets worse.
   
Total involvement in the study will last about 4 years.

Key Eligibility: 
  1. Adults with histologically or cytologically confirmed diagnosis of metastatic or advanced-stage malignancy
  2. Participants must have received prior locally approved standard of care appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or benefit from appropriate standard of care therapy

Detailed eligibility reviewed when participants contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Carina Puello, RN
(646) 962-3541
cap4008@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2212025478

ClinicalTrials.gov:

NCT04913285

Sponsor:

KN-8701

Status

Open to Enrollment

Age Group

Adult

Sponsor