Delving into the Latest Updates on STW204 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

ARMOZX, 抗PD-1人源化单抗(苏州思坦维), 阿沐珠

+ [2]

Target

PD-1

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication-

Inactive Indication

Advanced Malignant Solid Neoplasm

Originator Organization

Suzhou Stainwei Biotechnology Co., Ltd.

Active Organization-

Inactive Organization

Suzhou Stainwei Biotechnology Co., Ltd.

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

Login to view timeline

试验主要目的：评价单药hAB21注射液、hAB21注射液& hPV19注射液治疗晚期恶性实体瘤患者的耐受性、安全性；评估hAB21注射液给药的剂量限制性毒性（DLT）、最大耐受剂量（MTD），用于II期试验的推荐剂量次要目的：评价hAB21注射液、hAB21注射液& hPV19注射液药代动力学(PK)及免疫原性（ADA）特征；评价hAB21注射液、hAB21注射液& hPV19注射液临床有效性；探索hAB21注射液药效学特征

[Translation]

The main purpose of the trial is to evaluate the tolerability and safety of single-agent hAB21 injection, hAB21 injection & hPV19 injection in the treatment of patients with advanced malignant solid tumors; to assess the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of hAB21 injection, and the recommended dose for Phase II trials. Secondary objectives are to evaluate the pharmacokinetic (PK) and immunogenicity (ADA) characteristics of hAB21 injection, hAB21 injection & hPV19 injection; to evaluate the clinical effectiveness of hAB21 injection, hAB21 injection & hPV19 injection; to explore the pharmacodynamic characteristics of hAB21 injection.

Start Date02 Apr 2019

Sponsor / Collaborator