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.
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.
Details
This is a two-part, open-label, multi-center, dose escalation and dose expansion study in participants with BRAF mutation-positive and/or NRAS mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of KIN-2787, a RAF small molecule kinase inhibitor, to determine a recommended Phase 2 dose (RP2D) of KIN-2787, and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor.
The dose expansion phase (Part B) will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers that contain BRAF Class I, II or III mutations, including lung cancer, melanoma, and other selected solid tumors.
Keywords
Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma, BRAF inhibitor, BRAF, pan-RAF, pan-RAF inhibitor, RAF1, ARAF, BRAF alteration, BRAF Class II, BRAF Class III, V600, tumor growth inhibitor (TGI), NSCLC, solid tumor, targeted therapy, BRAF Class I, NRAS, Metastatic, Unresectable, CRC, ATC, Colon, Thyroid, Advanced, Exarafenib, binimetinib, KIN-2787, KIN-2787 and binimetinib