Delving into the Latest Updates on VT1093 with Synapse

Overview

Basic Info

Drug Type

DNA encoding mab, Oncolytic virus

Synonyms

VT-1093

Target

PD-1

Action

inhibitors

Mechanism

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

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Head and Neck NeoplasmsLiver CancerMalignant Solid Neoplasm

Inactive Indication-

Originator Organization

Beijing WellGene Biotech Co., Ltd.

Active Organization

Beijing WellGene Biotech Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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主要目的：评价VT1093瘤内单次给药及多次给药在复发或转移性实体瘤受试者中的安全性及耐受性，探索人体的最大耐受剂量（MTD）及剂量限制性毒性（DLT），为本品的后续拓展试验及Ⅱ期临床研究推荐安全剂量范围。次要目的：评估VT1093瘤内单次给药及多次给药在人体内的生物分布及生物效应。初步评价VT1093治疗复发或转移性实体瘤的客观有效率（ORR），疾病控制率（DCR）。

[Translation]

Main purpose: Evaluate the safety and tolerability of VT1093 in subjects with recurrent or metastatic solid tumors after single and multiple intratumoral administration, explore the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in humans, and recommend a safe dose range for subsequent extended trials and Phase II clinical studies of this product. Secondary purpose: Evaluate the biodistribution and biological effects of VT1093 in humans after single and multiple intratumoral administration. Preliminary evaluation of the objective response rate (ORR) and disease control rate (DCR) of VT1093 in the treatment of recurrent or metastatic solid tumors.

Start Date18 Mar 2021

Sponsor / Collaborator

Beijing WellGene Biotech Co., Ltd.

ChiCTR2500098232

/ CompletedPhase 1IIT

An open-label, dose-escalation phase I clinical trial of intratumoral injection of VT1093 for the treatment of adult patients with recurrent or metastatic malignant solid tumors

Start Date18 Mar 2021

Sponsor / Collaborator

Shanghai Pudong Hospital

100 Clinical Results associated with VT1093

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100 Translational Medicine associated with VT1093

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100 Patents (Medical) associated with VT1093

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100 Deals associated with VT1093

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Head and Neck Neoplasms	Phase 2	China	Beijing WellGene Biotech Co., Ltd.	-
Liver Cancer	Phase 2	China	Beijing WellGene Biotech Co., Ltd.	-
Malignant Solid Neoplasm	Phase 1	China	Beijing WellGene Biotech Co., Ltd.	18 Mar 2021

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Clinical Result

Indication

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Evaluation

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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