KST-6051 / Kestrel Therapeutics - LARVOL DELTA

Kestrel Therapeutics Receives FDA Fast Track Designation for KST-6051, a Potential Best-in-Class Pan-KRAS Inhibitor, in the treatment of KRAS-Mutant Advanced Solid Tumors (The Manila Times) - "KST-6051 is being evaluated in an ongoing first-in-human (FIH), dose-escalation Phase 1 study, denoted FALCON (NCT07458347) in patients with advanced or metastatic KRAS-mutant solid tumors."

Fast track • First-in-human • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Kestrel Therapeutics… announced that it has entered into a strategic agreement with AbbVie, a leading global biopharmaceutical company (GlobeNewswire) - "The deal is structured as a warrant agreement with an exclusive option for AbbVie to acquire Kestrel based on defined development milestones....Under the terms of the agreement AbbVie will support funding of the KST-6051 program and based on the completion of development and regulatory milestones will have the exclusive option to acquire Kestrel."

Licensing / partnership • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

Kestrel Therapeutics…announced that that the first patient has been dosed in its Phase 1 clinical trial evaluating KST-6051, its investigational, oral, small-molecule pan-KRAS inhibitor, in patients with advanced or metastatic solid tumors with KRAS mutations (GlobeNewswire) - "The Phase 1 study, KST-6051-101 (FALCON), is an open-label, multicenter, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of KST-6051 in patients with advanced solid tumors harboring KRAS mutations, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and other KRAS-driven malignancies."

Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation (clinicaltrials.gov) - P1 | N=145 | Recruiting | Sponsor: Kestrel Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor • KRAS

A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation (clinicaltrials.gov) - P1 | N=145 | Not yet recruiting | Sponsor: Kestrel Therapeutics, Inc.

First-in-human • New P1 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor • KRAS

Kestrel Therapeutics Announces IND Clearance by U.S. FDA of KST-6051, a Potential Best-in-Class Pan-KRAS Inhibitor, Enabling Initiation of Phase 1 Trial (The Manila Times) - "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....'We are excited to initiate our first study as we work toward initial clinical readouts anticipated in late 2026.'"

First-in-human • IND • New P1 trial • P1 data • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma