Delving into the Latest Updates on Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

PE 0105, PE-0105, PE0105

Target

PD-1

Action

inhibitors

Mechanism

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

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Shanghai Yunyi Health Technology Development Co., Ltd.

Active Organization

Shanghai HyaMab Biotechnology Co., Ltd.Shanghai Yunyi Health Technology Development Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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This study is a one-arm, open, multicenter phase 1b/2 clinical trial of PE0116combined with PE0105 in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.PE0105 is administered as a fixed-dose intravenous injection(3mg/kg Q3w）.

Start Date31 Aug 2023

Sponsor / Collaborator

Shanghai Yingli Pharmaceutical Co., Ltd.

[+1]

CTR20202517

/ Not yet recruitingPhase 1

一项单中心、开放、首次用于人体，评价PE0105注射液在晚期恶性实体瘤患者中安全性、耐受性和药代动力学特征的Ia期临床研究

[Translation] A single-center, open-label, first-in-human Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of PE0105 injection in patients with advanced malignant solid tumors

主要目的 1）评估PE0105单药治疗的安全性和耐受性； 2）确定PE0105单药治疗的最大耐受剂量（MTD）或最大给药剂量（MAD），以及II期试验推荐剂量（RP2D) 次要目的 1）分析PE0105在晚期实体肿瘤患者中单次给药的PK特性； 2）分析抗PE0105抗体（ADA）的产生情况； 3）按照RECIST1.1标准，初步评估PE0105在晚期实体肿瘤患者中的抗肿瘤活性。

[Translation]

Main objectives 1) Evaluate the safety and tolerability of PE0105 monotherapy; 2) Determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PE0105 monotherapy, as well as the recommended dose (RP2D) for Phase II trials Secondary objectives 1) Analyze the PK characteristics of a single dose of PE0105 in patients with advanced solid tumors; 2) Analyze the production of anti-PE0105 antibodies (ADA); 3) Preliminarily evaluate the anti-tumor activity of PE0105 in patients with advanced solid tumors according to RECIST1.1 criteria.

Start Date-

Sponsor / Collaborator

Shanghai Yunyi Health Technology Development Co., Ltd.

100 Clinical Results associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)

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100 Translational Medicine associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)

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100 Patents (Medical) associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)

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100 Deals associated with Recombinant human anti-PD-1 monoclonal antibody(Shanghai Yunyi Health Technology Development Co Ltd)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	Shanghai HyaMab Biotechnology Co., Ltd.	21 Sep 2023

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Biosimilar

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