Delving into the Latest Updates on SY-4798 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

SY 4798

Target

FGFR4

Mechanism

FGFR4 antagonists(Fibroblast growth factor receptor 4 antagonists)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid NeoplasmFGFR4 positive Neoplasms

Inactive Indication

Bile Duct NeoplasmsHepatocellular Carcinoma

Originator Organization

Shouyao Holdings (Beijing) Co. Ltd.

Active Organization

Shouyao Holdings (Beijing) Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要研究目的：在中国晚期实体瘤受试者中考察 SY-4798 的安全性及耐受性，确定最大耐受剂量（MTD）及 II 期推荐剂量（RP2D）。次要研究目的：评估SY-4798 在中国晚期实体瘤受试者中的药代动力学（PK）和药效学（PD）特征；初步评价SY-4798对成纤维细胞生长因子19（FGF19）阳性晚期实体瘤受试者的临床疗效。

[Translation]

The main purpose of the study is to investigate the safety and tolerability of SY-4798 in Chinese subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended dose for Phase II (RP2D). The secondary purpose of the study is to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of SY-4798 in Chinese subjects with advanced solid tumors; and to preliminarily evaluate the clinical efficacy of SY-4798 in subjects with advanced solid tumors that are positive for fibroblast growth factor 19 (FGF19).

Start Date15 Apr 2021

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

NCT05498519

/ RecruitingPhase 1

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

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.

Start Date15 Apr 2021

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

100 Clinical Results associated with SY-4798

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100 Translational Medicine associated with SY-4798

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100 Patents (Medical) associated with SY-4798

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100 Deals associated with SY-4798

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bile Duct Neoplasms	Phase 1	CN	Shouyao Holdings (Beijing) Co. Ltd.	23 Apr 2021
Hepatocellular Carcinoma	Phase 1	CN	Shouyao Holdings (Beijing) Co. Ltd.	23 Apr 2021
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shouyao Holdings (Beijing) Co. Ltd.	15 Apr 2021
FGFR4 positive Neoplasms	Phase 1	CN	Shouyao Holdings (Beijing) Co. Ltd.	15 Apr 2021