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 is a Phase I 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.

Start Date21 Sep 2023

Sponsor / Collaborator

Shanghai HyaMab Biotechnology Co., Ltd.

CTR20232109 / RecruitingPhase 1/2

一项评估PE0116联合PE0105注射液在晚期实体瘤患者中的耐受性、安全性和药代动力学特性以及初步有效性的Ib/II期临床研究

[Translation] A Phase Ib/II clinical study to evaluate the tolerability, safety, pharmacokinetic properties and preliminary efficacy of PE0116 combined with PE0105 injection in patients with advanced solid tumors

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

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 PE-0116

100 Translational Medicine associated with PE-0116

100 Patents (Medical) associated with PE-0116

Literatures (Medical) associated with PE-0116

01 Dec 2022·FEBS Open Bio

Development and characterization of a novel human CD137 agonistic antibody with anti‐tumor activity and a good safety profile in non‐human primates

Article

Author: Yang, Teddy ; Dai, Chaohui ; Gao, Yingying ; Song, Ningning ; Liu, Hu ; Ding, Yu

CD137 (4‐1BB, TNFRSF9), an inducible T‐cell costimulatory receptor, is expressed on activated T cells, activated NK cells, Treg cells, and several innate immune cells, including DCs, monocytes, neutrophils, mast cells, and eosinophils. In animal models and clinical trials, anti‐CD137 agonistic monoclonal antibodies have shown anti‐tumor potential, but balancing the efficacy and toxicity of anti‐CD137 agonistic monoclonal antibodies is a considerable hindrance for clinical applications. Here, we describe a novel fully human CD137 agonistic antibody (PE0116) generated from immunized harbor H2L2 human transgenic mice. PE0116 is a ligand blocker, which is also the case for Utomilumab (one of the leading CD137 agonistic drugs); PE0116 partially overlaps with Urelumab's recognized epitope. In vitro, PE0116 activates NF‐κB signaling, significantly promotes T‐cell proliferation, and increases cytokine secretion in the presence of cross‐linking. Importantly, PE0116 possesses robust anti‐tumor activity in the MC38 tumor model. In vivo, PE0116 exhibits a good safety profile and has typical pharmacokinetic characteristics of an IgG antibody in preclinical studies of non‐human primates. In summary, PE0116 is a promising anti‐CD137 antibody with a good safety profile in preclinical studies.

100 Deals associated with PE-0116

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	CN	Shanghai HyaMab Biotechnology Co., Ltd.	20 Sep 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20201794 (ASCO2022) Manual	Phase 1	Solid tumor	19	PE0116	(xsucybipip) = 1 g2 ascites, 1 g4 dyspnea, 1 g2 fever jyfrogpulb (eeowsdmdke ) View more	Positive	02 Jun 2022

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