On March 5, 2026 Kestrel Therapeutics Inc. ("Kestrel" or the "Company"), a clinical stage biotechnology company developing next-generation small-molecule inhibitors targeting mutant KRAS, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KST-6051, an investigational, oral, small-molecule inhibitor designed to target KRAS.
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Kestrel is advancing KST-6051 into the clinic and expects to initiate a first-in-human Phase 1 dose-escalation clinical trial FALCON by the end of the first quarter. The trial, designed to evaluate safety, tolerability and preliminary anti-tumor activity, will enroll patients with advanced or metastatic KRAS-mutant solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and others.
"IND approval for KST-6051 is a significant milestone for Kestrel and an important step forward for patients with KRAS-driven cancers," said Dr. Frank G. Haluska, President and Chief Executive Officer of Kestrel Therapeutics. "KST-6051 represents our next-generation approach to pan-KRAS inhibition, leveraging proprietary and unique Switch-II pocket chemistry to target KRAS in both the ON- and OFF-states. We are excited to initiate our first study as we work toward initial clinical readouts anticipated in late 2026."
About KST-6051
KST-6051 is a potential best-in-class, oral pan-KRAS inhibitor, developed for the treatment of KRAS-driven cancers. KST-6051 is a potent and selective inhibitor of KRAS with activity against KRAS in both its active (GTP-bound) and inactive (GDP-bound) states. Preclinical data demonstrate robust on-target pathway modulation, anti-proliferative activity, and efficacy at well-tolerated doses in multiple human KRAS mutant tumor models. The Company is initiating a Phase 1 study in patients with KRAS-mutant advanced/metastatic solid tumors. Its clinical development will ultimately address pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and other KRAS-driven malignancies.
(Press release, Kestrel Therapeutics, MAR 5, 2026, View Source [SID1234663319])