Delving into the Latest Updates on SHR-3821 with Synapse

Overview

Basic Info

Drug Type

Biological products

Synonyms

Target-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Active Organization

Shanghai Shengdi Pharmaceutical Co., Ltd.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Login to view timeline

评估SHR-3821注射液在晚期实体瘤患者中的安全性和耐受性，观察剂量限制性毒性（DLT），确定最大耐受剂量（MTD）以及SHR-3821的II期临床研究推荐剂量（RP2D）。评估SHR-3821在晚期实体瘤受试者中的药代动力学（PK）特征、药效动力学（PD）特征、免疫原性；初步评价SHR-3821治疗晚期实体瘤的疗效。

[Translation]

Evaluate the safety and tolerability of SHR-3821 injection in patients with advanced solid tumors, observe dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) and the recommended dose (RP2D) for Phase II clinical studies of SHR-3821. Evaluate the pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity of SHR-3821 in subjects with advanced solid tumors; preliminarily evaluate the efficacy of SHR-3821 in the treatment of advanced solid tumors.

Start Date-

Sponsor / Collaborator

Shanghai Shengdi Pharmaceutical Co., Ltd.

[+1]

NCT06618651 / Not yet recruitingPhase 1

Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3821 Injection in Subjects With Advanced Solid Tumors

This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.

Start Date15 Nov 2024

Sponsor / Collaborator

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with SHR-3821

Login to view more data

100 Translational Medicine associated with SHR-3821

Login to view more data

100 Patents (Medical) associated with SHR-3821

Login to view more data

100 Deals associated with SHR-3821

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	CN	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	14 Oct 2024
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shanghai Shengdi Pharmaceutical Co., Ltd.	14 Oct 2024