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

Study Overview
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Brief Summary
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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
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Debio 1347


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Debio 1347<br>Participants will receive Debio 1347 once daily from Day 1 to Day 28 in 28-Day cycles. | Drug: Debio 1347<br>* 80 milligrams (mg) dose of Debio 1347 orally once daily from Day 1 to Day 28 in 28-Day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | Up to 44 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response (DOR) |  | Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months) | 
| Disease Control Rate (DCR) |  | Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months) | 
| Progression-Free Survival (PFS) |  | Day 28 or end of Cycle (each cycle is 28 days) 2, 4, 6 followed by every 3 cycles (end of cycle) for up to 24 months or end of treatment or death due to any cause (up to 44 months) | 
| Overall Survival (OS) |  | Up to 44 months | 
| Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |  | Up to 44 months | 
| Trough Concentration (Ctrough) of Debio 1347 |  | Up to Cycle 2 (each cycle is 28 days) | 
| Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCt) of Debio 1347 |  | Up to Cycle 2 (each cycle is 28 days) | 
| Correlation of Debio 1347 plasma concentration and QTcF |  | Up to 44 months |