On November 5, 2026 Kayak Therapeutics, Inc. ("Kayak" or the "Company"), a clinical-stage biotechnology company developing novel approaches to targeted cancer therapy, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KT-300, an oral small-molecule inhibitor of TRIM7 and a potential first-in-class therapy for the treatment of RAS-driven cancers.
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Kayak expects to initiate a first-in-human Phase 1 dose-escalation clinical trial in late 2026. The trial, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KT-300, will enroll patients with advanced RAS mutant solid tumors, including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and others.
"FDA clearance of the IND for KT-300, a potential first-in-class TRIM7 inhibitor, is an important milestone for Kayak and brings our novel approach to RAS-driven cancers into the clinic," said Josiah Hornblower, CEO of Kayak Therapeutics. "TRIM7 sits at a critical downstream node of the RTK–RAS signaling cascade, and its hyperactivation drives tumor proliferation across a broad spectrum of cancers. Preclinical data demonstrate KT-300 not only blocks TRIM7 activity but does so in a way that is agnostic to the RAS-pathway mutation, and demonstrates anti-tumor activity in the setting of KRAS inhibitor resistance. These data underscore KT-300’s potential as a new therapeutic strategy for patients with RTK–RAS-driven cancers, a population with significant unmet medical need. We are excited to initiate our first study as we work toward initial clinical readouts anticipated in 2027."
About KT-300
KT-300 is an investigational, potentially first-in-class oral small-molecule inhibitor of TRIM7, a key mediator of RTK–RAS-driven tumor cell proliferation. Preclinical studies from Kayak demonstrate that KT-300 induces robust tumor growth inhibition in both in vitro and in vivo models. KT-300’s anti-tumor activity is RAS-pathway–mutation agnostic, offering broad therapeutic potential for cancers driven by hyperactivated RTK–RAS signaling. Kayak expects to initiate its first-in-human Phase 1 dose-escalation clinical trial by the end of the fourth quarter.
(Press release, Kayak Therapeutics, NOV 5, 2026, View Source [SID1234674373])