First Patient Treated in Study to Determine Tolerability, Dosing of Investigational Drug in Certain Solid Tumors

The first patient has received a dose of a novel drug candidate in an early-phase trial investigating the preliminary tolerability and proper dosage of the treatment in a group of patients with advanced solid tumors that harbor the FGFR2 and/or FGFR3 gene alterations, according to a press release.

“With the dosing of the first patient in our phase 1 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 tumors,” Dr. Richard Williams, the chief medical officer of Kinnate Biopharma, the manufacturer of the investigational therapy, said in the release.

The trial, known as KN-4802, is a multi-center, open-label (meaning both provider and patient know what treatment the patient is receiving) study aimed at evaluating the safety and efficacy of this therapy. The plan, according to the release, is to enroll approximately 120 patients across the two-part study. The first part of the trial is so that the study authors can determine the recommended dose of KIN-3248. Once they determine the recommended dose, the authors will then begin treating patients with intrahepatic cholangiocarcinoma (a type of liver cancer), urothelial carcinoma (a type of bladder cancer) and other solid tumors driven by alterations in the FGFR2 and/or FGFR3 gene.

Patients enrolled on the trial are expected to be administered the study drug orally once a day in 28-day cycles. During the second part of the trial, the investigators plan to review several outcome measures including objective response rate (which is the proportion of patients whose disease responds to treatment) and progression-free survival (the time from treatment until documented tumor progression).

“Successfully treating (intrahepatic cholangiocarcinoma) and (urothelial carcinoma) patients with FGFR2 and/or FGFR3 gene alteration-driven cancers remains a significant unmet need in cancer care. KIN-3248 brings a unique approach to potentially address the shortcomings of existing therapies in specific patient populations with primary FGFR2 and/or FGFR3 oncogenic alterations, including those patients with gatekeeper, molecular brake, and activation loop mutations,” Dr. Benjamin Garmezy, assistant director of Genitourinary Research for Sarah Cannon Research Institute at Tennessee Oncology in Nashville.

The study is expected to be fully complete by September 2026.

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