Studieoverzicht

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

Histology	NSCLC, all subtypes, Other, SCLC, Mesothelioma
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
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