Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05498519
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2022-08-10
Brief Title:
A First-in-Human Phase 1 Study of SY-4798 in Patients With Advanced Solid Tumor
Sponsor:
Shouyao Holdings Beijing Co LTD
Organization:
Shouyao Holdings Beijing Co LTD
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Dose-expansion phase is designed to evaluate the anti-tumor activity ORR and DOR of SY-4798 in patients with FGF19 advanced tumor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None