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Clinical Trial 19945

Cancer Type: Genitourinary
Interventions:Debio 1347

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Rutika Mehta

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in subjects with solid tumors harboring a fusion of FGFR1, FGFR2 or FGFR3 "The FUZE Clinical Trial"

Summary

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.

Objective

Primary objective: To assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in subjects with solid tumors harboring FGFR1-3 gene fusion/rearrangement. Secondary objectives 1. To evaluate the efficacy of Debio 1347 in terms of duration of response (DoR), DCR, progression free survival (PFS) and overall survival (OS). 2. To assess the safety of Debio 1347. 3. To assess exposure-response relationships vs efficacy and safety (notably QTcF). Exploratory objectives 1. To assess the Debio 1347 cytochrome P450 (CYP)3A induction potential using 4ß-hydroxycholesterol/cholesterol as a marker. 2. To assess the effects of intrinsic factors (such as demographic, pathophysiological - including renal and liver function - or pharmacogenetic (PGx) characteristics) and extrinsic factors (such as concomitant medications) on the PK of Debio 1347. 3. To assess the impact of biomarkers on the efficacy of Debio 1347 and appearance of resistance to Debio 1347. 4. To assess patient-reported outcome (PRO) by quality of life (QOL) questionnaire.

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
  • Other criteria may apply

  • 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)
  • Other criteria may apply