Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)

Status:	Recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/31/2019
Start Date:	March 1, 2019
End Date:	August 31, 2022
Contact:	Debiopharm International S.A
Email:	clinicaltrials@debiopharm.com
Phone:	+41 21 321 01 11

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 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)

We found this trial at

sites

University of Wisconsin

Madison, Wisconsin 53792

(608) 263-2400