Kinnate Biopharma has dosed the first subject in Phase I KN-4802 clinical trial of its Fibroblast Growth Factor Receptor (FGFR) product candidate, KIN-3248.
An irreversible, small molecule pan-FGFR inhibitor, KIN-3248 is being developed to treat intrahepatic cholangiocarcinoma (ICC), urothelial carcinoma (UC) and various other solid tumours.
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It can potentially act on both primary FGFR2 and FGFR3 oncogenic alterations and those claimed to induce acquired resistance to existing FGFR-targeted treatments, including gatekeeper, molecular brake and activation loop mutations seen in tumours such as ICC and UC.
The open-label, multicentre, two-part trial will assess the safety, tolerability, pharmacokinetics (PK), and initial efficacy of KIN-3248 in adult subjects.
It will enrol a total of 120 subjects with advanced cancers with FGFR2 and/or FGFR3 gene alterations.
The Part A or dose-escalation segment of the trial will detect the recommended dose and dosing schedule of the company’s FGFR inhibitor for further analysis in individuals with FGFR2 and/or FGFR3 gene alteration-driven tumours.
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By GlobalDataIn the dose-expansion phase or Part B of the trial, the safety and efficacy of the KIN-3248 at the recommended dose and schedule will be analysed in FGFR inhibitor-naïve and -pre-treated subjects with FGFR2 and/or FGFR3 gene alteration-driven cancers.
Kinnate chief medical officer Richard Williams said: “With the dosing of the first patient in our Phase I trial of KIN-3248, we are excited to further advance the development of this next-generation therapy which we believe is unique among FGFR inhibitors and has the potential to offer a new targeted therapy option for cancer patients with FGFR-altered tumours.
“We are grateful for the contribution of all the participants in this multicentre trial and for the support of our clinical collaborators at each trial site.”
KIN-3248 was found to possess inhibitory activity across various clinically significant mutations that induce primary disease and acquired resistance to other FGFR inhibitors, in preclinical studies.
