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Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
Trial Status: administratively complete
The primary objective of this study is to assess the efficacy of Debio 1347 in terms of
objective response rate (ORR) in participants with solid tumors harboring fibroblast
growth factor receptor (FGFR)1-3 gene fusion/rearrangement.
Inclusion Criteria
Cytologically or histologically confirmed advanced solid tumor
Radiographic progression on prior systemic therapy; prior localized therapy (i.e., radiation, ablation, embolization) is allowed provided radiographic progression out-of-field or in the treatment, field is shown
Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene fusion/rearrangement potentially leading to a functional FGFR aberrant protein, identified through local and/or central molecular assay
Exclusion Criteria
History of hypersensitivity to any of the excipients in the Debio 1347 formulation
History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon calcifications
Administration of any investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03834220.
