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

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase I

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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.
In Part B Dose Expansion, patients with BRAF Class I mutations are excluded.
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.

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