Clinical trial · Interventional
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| FGFR2 Gene Fusion/Rearrangement | — | UNRESOLVED | — |
| Other Solid Tumors, Adult | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lirafugratinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lirafugratinib
- description
- Treatment with standard dose of lirafugratinib
- interventionNames
- Drug: Lirafugratinib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.
- timeFrame
- Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Secondary outcomes (22)
- measure
- Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1.
- timeFrame
- Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable, locally advanced, or metastatic solid tumor (other than CCA). * Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor. * Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1. * Previously (\>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies. * Subject has not received prior treatment with an FGFRi. Exclusion Criteria: * An uncontrolled comorbidity. * Patient does not have adequate organ function (defined in protocol). * Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol). * QT interval corrected using Fridericia's formula (QTcF) \> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome. * Clinically significant, uncontrolled cardiovascular disease. * CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.
References
Publications (0)
Data not yet available