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Studieoverzicht

Study name: DR22LOXO: An open-label, Multicenter study of LOXO-435 (LY3866288) in Advanced Solid Tumor Malignancies with FGFR3 Alterations

Histology NSCLC, Other
Tumor stage Stage III - IV
Host / recruiting site 1 Erasmus MC Enrollment On hold
Therapy line Later line (≥2L)
Design

This is a Phase 1a/b, open-label, multicenter study of LOXO-435 in participants with FGFR3-altered advanced solid tumors, including advanced or metastatic urothelial cancer (UC).
Intervention

LOXO-435 is a potent, isoform-selective inhibitor of FGFR3 that is being developed to treat advanced solid tumors with activating gene alterations in FGFR3.
Key outcome parameters

Safety and dose finding of LOXO-435
Key inclusion criteria
  • Histologic diagnosis of locally advanced or metastatic solid tumor malignancy (except central nervous system [CNS] primary malignancy i.e., glioma) with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable, as defined below per specified cohort.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria

-There is no restriction on number of prior therapies.
-Suspected or known uncontrolled CNS involvement.
-Significant cardiovascular disease
Contact information