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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"
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.
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.