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

Debiopharm International SA0 sites125 target enrollmentFebruary 25, 2019

ConditionsThree cohorts will be included consisting of subjects with biliary tract cancer (Cohort 1), urothelial cancer (Cohort 2) and all other solid tumor histologies not included in Cohorts 1-2 such as NSCLC, head and neck cancer, thyroid cancer, oral cancer, breast cancer, prostate cancer and others but excluding primary brain tumors (Cohort 3).Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Three cohorts will be included consisting of subjects with biliary tract cancer (Cohort 1), urothelial cancer (Cohort 2) and all other solid tumor histologies not included in Cohorts 1-2 such as NSCLC, head and neck cancer, thyroid cancer, oral cancer, breast cancer, prostate cancer and others but excluding primary brain tumors (Cohort 3).
Sponsor: Debiopharm International SA
Enrollment: 125
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 25, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Debiopharm International SA

Eligibility Criteria

Inclusion Criteria

•1\. Written informed consent given according to ICH/GCP guidelines and local regulations.
•2\. Cytologically or histologically confirmed advanced solid tumor.
•3\. 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.
•4\. Male or female \=18 years of age.
•5\. 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.
•6\. The subject must have received at least one prior line of standard therapy appropriate for tumor type and stage of disease (if available), and, in the opinion of the Investigator, s/he would have been unlikely to tolerate or derive clinically meaningful benefit from further appropriate standard of care therapy. In particular:
•a. Biliary tract cancer subjects must have progressed on/after gemcitabine\-based chemotherapy (including subjects who progressed within 6 months of gemtabicine\-based adjuvant chemotherapy). Subjects can have received additional chemotherapy after documented intolerance to gemcitabine.
•b. Urothelial cancer subjects must have progressed on/after cisplatin\-based or carboplatinbased chemotherapy either given for advanced disease or within 12 months from completion if given as neoadjuvant or adjuvant therapy and anti\-PD1/PDL1 therapy (unless not available, contraindicated for some reasons or refused by the subject).
•c. NSCLC subjects must have progressed on chemotherapy and anti PD1/PDL1 therapy (unless contraindicated for some reasons). Subjects with known EGFR mutations, ALK rearrangement or BRAF V600E mutation must have received the relevant target therapy (unless not available).
•d. For all other tumor types, subjects must have progressed on/after appropriate SOC therapy (evidence\-based level 1\). Subjects who harbor genomic aberrations for which approved target therapy is available must have received such therapy. HER2\+ or ER/PR\+ breast cancer subjects should have received at least one line of HER2\-targeted or ER\-targeted, respectively.

Exclusion Criteria

•1\. History of hypersensitivity to any of the excipients in the Debio 1347 formulation.
•2\. Prior treatment with a FGFR1\-3 selective inhibitor.
•3\. 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.
•4\. Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
•5\. Chemotherapy, radiotherapy or small molecule anti\-cancer agents within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors).
•6\. Administration of any investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors).
•7\. Surgery requiring general anesthesia, except diagnostic biopsy or local procedure, within 3 weeks prior to initial dosing with Debio 1347 and/or if the subject has not fully recovered from the surgery.
•8\. Grade \> 1 NCI\-CTCAE v5\.0 AEs or toxicities from previous treatments except:
•a. Albumin (\= 2\.5 g/dL is allowed).
•b. AST and ALT in subjects with liver metastases.