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

a study on Solid Tumor

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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.

Official 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

Keywords

Solid Tumor Neoplasms Debio 1347

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • Sarcoma Oncology Center accepting new patients
    Santa Monica California 90403 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Debiopharm International SA
Links
Study Website.
ID
NCT03834220
Phase
Phase 2
Study Type
Interventional
Last Updated