Recruiting
Phase 2

Lirafugratinib

Sponsor:

Elevar Therapeutics

Code:

NCT07359820

Conditions

FGFR2 Gene Fusion/Rearrangement

Other Solid Tumors, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lirafugratinib

Study Details

Brief summary:

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

FGFR2 Gene Fusion/Rearrangement

Other Solid Tumors, Adult

Study ID

NCT07359820

Start date

Jun 4, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lirafugratinib

Treatment with standard dose of lirafugratinib

Interventions

Lirafugratinib

Lirafugratinib is an oral inhibitor of FGFR2

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 and Locations

Central contacts

Elevar Therapeutics

+1 (385) 276-3800info-clinicalstudy@elevartx.com

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Moffitt Clinical Trials Information

1-855-470-6706

Principal Investigator:

Richard Kim, MD

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

General Office of Clinical Research

8666706277cancerclinicaltrials@bsd.uchicago.edu

UChicago Medicine Cancer Clinical Trials Office

8557028222

Principal Investigator:

Chih-Yi Liao, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Mass General Hospital

877-789-6100

Principal Investigator:

Andreas Varkaris, MD, PhD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Memorial Sloan Kettering Cancer Center

800-525-2225referapatient@mskcc.org

Principal Investigator:

Alison Schram, MD

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

UT M.D. Anderson Cancer Center Clinical Trial Information

1-877-632-6789

Principal Investigator:

Jordi Rodon Ahnert, MD, PhD

More Information

Sponsor

Elevar Therapeutics

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Elevar Therapeutics on 2026-09-03.