Delving into the Latest Updates on SY-4835 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

SY-4835

Target

WEE1

Action

inhibitors

Mechanism

WEE1 inhibitors(Serine/threonine-protein kinase WEE1 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication

Pancreatic Cancer

Originator Organization

Shouyao Holdings (Beijing) Co. Ltd.

Active Organization

Shouyao Holdings (Beijing) Co. Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Login to view timeline

主要研究目的：在中国晚期实体瘤受试者中考察 SY-4835 的安全性及耐受性，确定最大耐受剂量（MTD）、剂量限制性毒性（DLT）及 II 期推荐剂量（RP2D）。次要研究目的：评估 SY-4835 在中国晚期实体瘤受试者体内的药代动力学（PK）特征；初步评价 SY-4835 在晚期实体瘤受试者中的疗效。探索性目的：探索潜在预测 SY-4835 疗效的生物标志物。

[Translation]

Primary study objectives: To investigate the safety and tolerability of SY-4835 in Chinese subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended dose for Phase II (RP2D). Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics of SY-4835 in Chinese subjects with advanced solid tumors; to preliminarily evaluate the efficacy of SY-4835 in subjects with advanced solid tumors. Exploratory objectives: To explore potential biomarkers for predicting the efficacy of SY-4835.

Start Date22 Nov 2021

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

NCT05291182

/ Unknown statusPhase 1

A First-in-human, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of SY-4835 Tablets in Patients With Advanced Solid Tumor

This is a phase 1, open-label, single-arm, first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of SY-4835 administered orally in patients with advanced solid tumors.

Start Date28 Jun 2021

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

100 Clinical Results associated with SY-4835

Login to view more data

100 Translational Medicine associated with SY-4835

Login to view more data

100 Patents (Medical) associated with SY-4835

Login to view more data

100 Deals associated with SY-4835

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	China	Shouyao Holdings (Beijing) Co. Ltd.	28 Jun 2021
Pancreatic Cancer	Phase 1	China	Shouyao Holdings (Beijing) Co. Ltd.	22 Apr 2021