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

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Trial ID: NCT04913285

Purpose

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

Official Title

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.

Stanford Investigator(s)

Christopher T Chen, MD
Christopher T Chen, MD

Assistant Professor of Medicine (Oncology)

Eligibility


Inclusion Criteria:

   - Provide written informed consent prior to initiation of any study-specific procedures.

   - Metastatic or advanced stage solid tumor

   - Known BRAF Class I, Class II, or Class III alteration or melanoma with an NRAS
   mutation as confirmed by previous genomic analysis of tumor tissue or ctDNA.

   - Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1.

   - ECOG performance status 0-1

   - Adequate organ function, as measured by laboratory values (criteria listed in
   protocol).

   - Able to swallow, retain, and absorb oral medications.

Exclusion Criteria:

   - Known participants who have received local therapy with either surgery and/or
   radiation therapy (participants with asymptomatic untreated brain metastasis may be
   eligible if met with certain criteria)

   - In Part B Dose Expansion, previous treatment with any approved or in-development small
   molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy.

   - GI tract disease causing an inability to take oral medication, malabsorption syndrome,
   requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.

   - Active, uncontrolled bacterial, fungal, or viral infection.

   - Participant with a positive test result for SARS-CoV2 infection, is known to have
   asymptomatic infection or is suspected of having SARS-CoV2, is excluded

   - Women who are lactating or breastfeeding, or pregnant.

   - Participants with any other active treated malignancy within 3 years prior to
   enrollment

Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Intervention(s):

drug: KIN-2787

drug: KIN-2787 and binimetinib

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Aja Macias
+1 650-497-7499

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