Delving into the Latest Updates on GR-1405 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

GR 1405, GR1405

Target

PDL1

Action

inhibitors

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsMouth and Tooth DiseasesOtorhinolaryngologic Diseases+ [4]

Active Indication-

Inactive Indication

Advanced Malignant Solid NeoplasmAdvanced Triple-Negative Breast CarcinomaLymphoma+ [3]

Originator Organization

Zhixiang (Shanghai) Medical Technology Co., Ltd.

Active Organization-

Inactive Organization

Chongqing Genrix Biopharmaceutical Co., Ltd.

License Organization-

Drug Highest PhaseSuspendedPhase 3

First Approval Date-

Regulation-

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To evaluate the preliminary efficacy of GR1405 injection combined with gemcitabine + cisplatin (GP) as first-line or second-line treatment for patients with advanced triple-negative breast cancer. To evaluate the safety, immunogenicity and pharmacokinetic characteristics of GR1405 injection combined with gemcitabine + cisplatin (GP) as first-line or second-line treatment for patients with advanced triple-negative breast cancer.

Start Date11 Jun 2020

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

ChiCTR2000029189

/ SuspendedPhase 1/2

A phase Ib/II, randomized, open label, multicenter controlled trial for evaluation of the efficacy and safety of GR1405 injection in combination with gemcitabine and cisplatin(GP) in the first-line treatment of patients with advanced triple-negative breast

Start Date05 Jan 2020

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+2]

CTR20181522

/ TerminatedPhase 2

评价GR1405注射液在晚期实体肿瘤患者中重复给药、剂量扩展的安全性及初步疗效的II期临床研究

[Translation] A Phase II clinical study to evaluate the safety and preliminary efficacy of repeated dosing and dose expansion of GR1405 injection in patients with advanced solid tumors

评价GR1405注射液在中国晚期实体肿瘤患者中的初步疗效；评价GR1405注射液在中国晚期实体肿瘤患者中长期用药的安全性、免疫原性和药代动力学特征。

[Translation]

To evaluate the preliminary efficacy of GR1405 injection in Chinese patients with advanced solid tumors; to evaluate the safety, immunogenicity and pharmacokinetic characteristics of GR1405 injection in Chinese patients with advanced solid tumors for medium to long term use.

Start Date16 Sep 2019

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with GR-1405

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100 Translational Medicine associated with GR-1405

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100 Patents (Medical) associated with GR-1405

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100 Deals associated with GR-1405

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nasopharyngeal Cancer, Recurrent	Phase 3	China	Chongqing Genrix Biopharmaceutical Co., Ltd.	06 Jun 2022
Nasopharyngeal Carcinoma	Phase 3	China	Chongqing Genrix Biopharmaceutical Co., Ltd.	06 Jun 2022
Advanced Triple-Negative Breast Carcinoma	Phase 2	China	Chongqing Genrix Biopharmaceutical Co., Ltd.	11 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 2	China	Chongqing Genrix Biopharmaceutical Co., Ltd.	16 Sep 2019
Squamous Cell Carcinoma of Head and Neck	Phase 2	China	Chongqing Genrix Biopharmaceutical Co., Ltd.	16 Sep 2019
Lymphoma	Phase 1	China	Chongqing Genrix Biopharmaceutical Co., Ltd.	01 Nov 2018

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Biosimilar

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