Trial NCT07359820
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
- Phase
- Phase 2
- Sponsor
- Elevar Therapeutics
- Conditions
- FGFR2 Gene Fusion/Rearrangement; Other Solid Tumors, Adult
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* 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).HIV 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.Cardiac
* Clinically significant, uncontrolled cardiovascular disease.
* CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.Brain metastases
Restrictions found (4)
- Brain metastasesConditionalexclusionShow in the text
- CardiacOutrightexclusion
QTcF > 480 msec
Show in the text - HIVConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County