A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement (ReFocus202)

Elevar Therapeutics

Status and phase

Not yet enrolling

Phase 2

Conditions

Other Solid Tumors, Adult

FGFR2 Gene Fusion/Rearrangement

Treatments

Drug: Lirafugratinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT07359820

ELE-4008-202

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.