Phase 2: testing Lirafugratinib for FGFR2 Gene Fusion/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.
Official registry: https://clinicaltrials.gov/study/NCT07359820 · Elevar Therapeutics · enrollment listed as 30
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Lirafugratinib. The registry lists allocation as na. 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.
They plan to enroll about 30 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Lirafugratinib
Primary outcome (registry wording): Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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 how well you can do daily activities (ECOG score) 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
Who the registry excludes
- 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
Public study contact (from the registry)
Elevar Therapeutics
info-clinicalstudy@elevartx.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
19 listed- Mayo Clinic — Phoenix, Arizona (not_yet_recruiting)
- Mayo Clinic — Jacksonville, Florida (not_yet_recruiting)
- Moffitt Cancer Center — Tampa, Florida (recruiting)
- University of Chicago Medical Center — Chicago, Illinois (recruiting)
- Massachusetts General Hospital — Boston, Massachusetts (recruiting)
- Mayo Clinic — Rochester, Minnesota (not_yet_recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York (recruiting)
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas (recruiting)
+ 11 sites outside the US on the same record
FAQ about this NCT record
Is NCT07359820 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07359820?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07359820?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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