• First patient was dosed at Samsung Medical Center in Seoul, South Korea; a second at Moffitt Cancer Center in Tampa, Florida
• Global multi-site study includes locations in U.S., Korea, the UK, Spain, and France
• Study aims to confirm lirafugratinib’s potential efficacy among patients with FGFR2 fusion/rearrangement independent of tumor type
  
  

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the first patients were dosed in its global Phase 2 study of lirafugratinib in non-cholangiocarcinoma (CCA) solid tumors with FGFR2 fusion or rearrangement.

“Elevar believes lirafugratinib has much potential as a strong anti-tumor therapy across a wider range of FGFR2 fusion or rearrangement driven tumors. We are committed to do our best to obtain meaningful study results to present to the FDA,” said Dong-Gun Kim, chief executive officer of Elevar. “We are pleased that the first patients have been dosed and we look forward to completing enrollment.”

The trial, known as ReFocus202 (Protocol ID ELE-4008-202; NCT07359820), is an open-label, single-arm study evaluating the efficacy and safety among a broad scope of tumors containing an FGFR2 fusion or rearrangement. The primary endpoint is objective response rate.

The first patient was dosed at Samsung Medical Center in Seoul, South Korea, and a second patient at Moffitt Cancer Center in Tampa, Florida. The multi-site study is set to take place in the U.S., Korea, the UK, Spain, and France.

“Patients with advanced solid tumors harboring FGFR2 fusions or rearrangements often have limited treatment options, particularly beyond cholangiocarcinoma,” said Dr. Richard Kim, ReFocus202 principal investigator and service chief of medical gastrointestinal oncology at Moffitt Cancer Center. “This study gives us an important opportunity to better understand whether selective FGFR2 inhibition with lirafugratinib can benefit a broader group of patients whose tumors are driven by FGFR2 alterations. I am pleased that our team was able to enroll the first patient in the U.S. and contribute to this important effort.”

Lirafugratinib received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for CCA. Priority review of its new drug application for the treatment of patients with CCA with FGFR2 fusion/rearrangement who have received prior therapy is ongoing by the FDA, which set a Prescription Drug User Fee Act date of Sep 27, 2026.

ReFocus202 aims to confirm the tumor-agnostic potential of lirafugratinib in patients with FGFR2 fusion/rearrangement.

In the Phase 1/2 ReFocus study, data from 42 non-CCA solid tumor patients with FGFR2 fusion/rearrangement (13 tumor types) showed meaningful antitumor activity of lirafugratinib. Elevar plans to leverage that dataset, along with data generated under ReFocus202, to conduct an interim analysis across at least seven tumor types with at least five patients per tumor type.