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
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.
The primary objectives of the Part A Dose Escalation portion of the study are to determine the safety and tolerability of oral administration of KIN-2787 including dose-limiting toxicities (DLT) in subjects with Rapidly Accelerated Fibrosarcoma, Homolog B (BRAF) mutation positive advanced or metastatic solid tumors, to characterize the PK properties of KIN-2787, and to identify the maximum tolerated dose (MTD) and/or the appropriate dose for further clinical investigation.
The primary objective of the Part B Dose Expansion portion of the study is to assess preliminary evidence of the anti-tumor activity of KIN-2787 in subjects with advanced or metastatic solid cancers that harbor either a Class II or Class III BRAF genomic alteration.
The secondary objective is to characterize the PK of KIN-2787 following administration of an oral tablet formulation, including in a fed and fasted state.
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