A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

Conditions

• FGFR2 Gene Fusion/Rearrangement
• Other Solid Tumors, Adult

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lirafugratinib — DRUG
  Lirafugratinib is an oral inhibitor of FGFR2

Study Details

The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: * Take lirafugratinib regularly as instructed by their study doctor. * Visit the clinic as instructed for checkups and tests. * Keep a diary recording each time a dose of lirafugratinib is taken.

Key Dates

Start date

Jun 4, 2026

Status verified

Jun 2026

Primary completion

Sep 30, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lirafugratinib
  Treatment with standard dose of lirafugratinib

Primary Outcome Measure

Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1. [ Time Frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months. ]

Central Contacts

• Jacki Dillingham
  +1 (385) 276-3611
  [email protected]
• Lissa Nazal
  +1 (385) 276-3621
  [email protected]

Locations (7)

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