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-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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主要目的 (1) 评价PE0116联合PE0105在晚期实体瘤患者的安全性和耐受性。 (2) 探索PE0116联合PE0105的最大耐受剂量(Maximal Tolerated Dose，MTD)，确定2期推荐剂量(Recommended Phase 2 Dose，RP2D)。 (3) 评价PE0116联合PE0105在晚期实体瘤患者中的有效性。

[Translation]

Main objectives (1) To evaluate the safety and tolerability of PE0116 combined with PE0105 in patients with advanced solid tumors. (2) To explore the maximum tolerated dose (MTD) of PE0116 combined with PE0105 and determine the recommended phase 2 dose (RP2D). (3) To evaluate the efficacy of PE0116 combined with PE0105 in patients with advanced solid tumors.

Start Date20 Sep 2023

Sponsor / Collaborator

Shanghai HyaMab Biotechnology Co., Ltd.

NCT06026501

/ Not yet recruitingPhase 1/2

A Phase Ib/II Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor

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.

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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

10 top R&D records.

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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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Clinical Result

Indication

Phase

Evaluation

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Approval

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Biosimilar

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