NCT05498519

A First-in-Human, Phase 1 Study of SY-4798 in Patients With Advanced Solid Tumor

A Phase I, Open-Label, Multi-Center, Dose-escalation/ Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-Tumor Activity of SY-4798 Tablet in Patients With Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label and multicenter study of SY-4798, a highly specific and potent inhibitor of FGFR4, in patients with advanced solid tumor. This study has two phases: dose-escalation phase and dose-expansion phase.

Detailed description

Dose-escalation phase is designed to determine the DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and characterize the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of SY-4798. Other dose regimens may be explored based on the analysis of emerging PK and safety data. At this study phase, SY-4798 will be administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumor. Dose-expansion phase is designed to evaluate the anti-tumor activity (ORR and DOR) of SY-4798 in patients with FGF19+ advanced tumor.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SY-4798	FGFR4 selective inhibitor

Timeline

• Start date: 2021-04-15
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2022-08-12
• Last updated: 2023-05-11

Locations

1 site across 1 country: China