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NCT Number: NCT07359820

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

FGFR2 Gene Fusion/Rearrangement Other Solid Tumors, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Bergonie, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lirafugratinib

Drug

Lirafugratinib is an oral inhibitor of FGFR2

Other names: RLY-4008

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duration of response (DOR) 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.

  2. Number of patients with adverse events and serious adverse events.

    Time frame: Every cycle (4-week cycles) until study discontinuation, approximately 24 months.

  3. Number of patients with dose interruptions.

    Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

  4. Number of patients with dose reductions.

    Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

  5. Number of patients with dose discontinuations.

    Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

  6. Objective Response Rate (ORR) as assessed by Investigator 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.

  7. Duration of Response (DOR) as assessed by Investigator 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

  8. Disease control rate (DCR) as assessed by Investigator and 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.

  9. Progression-free survival (PFS) as assessed by Investigator and 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

  10. Overall survival (OS).

    Time frame: Up to approximately 36 months.

  11. Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.

    Time frame: Up to approximately 36 months.

  12. Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.

    Time frame: Up to approximately 36 months

  13. Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)

    Time frame: [Time Frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)]

  14. Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)

    Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)

  15. Pharmacokinetic parameters including half-life (t1/2)

    Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)

  16. Change from baseline in quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

    Time frame: Approximately every 4 weeks during treatment, approximately 24 months

    It scores (0-100) where higher means better function/quality of life in that section of the questionnaire and higher means worse symptoms in that section of the questionnaire.

  17. Time to deterioration (TTD).

    Time frame: Up to approximately 36 months.

  18. FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.

    Time frame: Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months.

  19. Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23).

    Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months.

  20. Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)

    Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months

  21. Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)

    Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months

  22. Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacki Dillingham

CONTACT

[email protected]

+1 (385) 276-3611

Lissa Nazal

CONTACT

[email protected]

+1 (385) 276-3621

Sponsors and collaborators

Lead sponsor

Elevar Therapeutics

Industry

Registry information

Official study title

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

Acronym: ReFocus202

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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