[Translation] A single-arm, multicenter, phase II study to evaluate the efficacy and safety of LZM009 in patients with recurrent or metastatic thymic carcinoma who have failed at least one line of chemotherapy

主要目的：由独立影像评估委员会依据RECIST V1.1评价LZM009治疗至少接受过一线化疗失败的复发或转移性胸腺癌患者的客观缓解率（ORR）次要目的：研究中心评估的ORR，评估受试者OS、PK、ADA、分析组织中潜在的能预测疗效的生物标志物与疗效的关系。

[Translation]

Primary objective: To evaluate the objective response rate (ORR) of LZM009 in patients with recurrent or metastatic thymic carcinoma who have failed at least one line of chemotherapy according to RECIST V1.1 by an independent imaging evaluation committee. Secondary objectives: ORR assessed by the research center, evaluation of subjects' OS, PK, ADA, and analysis of the relationship between potential biomarkers in tissues that can predict efficacy and efficacy.

Start Date02 Apr 2020

Sponsor / Collaborator

Livzon MABPharm Inc.

CTR20191862

/ RecruitingPhase 1

LZM009作为巩固治疗在含铂类同步化放疗后的Ⅲ期非小细胞肺癌患者中单臂、非盲、剂量扩展的Ib期临床试验

[Translation] A single-arm, open-label, dose-expansion phase Ib clinical trial of LZM009 as consolidation therapy in patients with stage III non-small cell lung cancer after concurrent platinum-containing chemoradiotherapy

评价LZM009在基于铂类同步化放疗后未发生疾病进展的局部晚期、不可切除的Ⅲ期非小细胞肺癌患者中的安全性及耐受性。评价LZM009在Ⅲ期非小细胞肺癌患者中的药代动力学（PK）特征；观察LZM009在Ⅲ期非小细胞肺癌患者中的初步抗肿瘤疗效。

[Translation]

To evaluate the safety and tolerability of LZM009 in patients with locally advanced, unresectable stage III non-small cell lung cancer who have not progressed after concurrent platinum-based chemoradiotherapy. To evaluate the pharmacokinetic (PK) characteristics of LZM009 in patients with stage III non-small cell lung cancer; to observe the preliminary anti-tumor efficacy of LZM009 in patients with stage III non-small cell lung cancer.

Start Date04 Dec 2019

Sponsor / Collaborator

Livzon MABPharm Inc.

CTR20180494

/ RecruitingPhase 1

多中心、开放、评估LZM009在中国晚期恶性实体瘤患者中安全性、耐受性、药代动力学特征和初步疗效的I期临床研究

[Translation] A multicenter, open-label, Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LZM009 in Chinese patients with advanced malignant solid tumors

评价LZM009在晚期实体瘤患者中的安全性和耐受性，为II期临床试验推荐给药剂量(RP2D)的确定提供依据；考察LZM009在晚期实体瘤患者中单、多次静脉滴注给药的药代动力学特征(PK参数)、考察LZM009在晚期实体瘤患者中单、多次静脉滴注给药后产生抗LZM009抗体(ADA)的情况。

[Translation]

To evaluate the safety and tolerability of LZM009 in patients with advanced solid tumors, and provide a basis for determining the recommended dose (RP2D) for Phase II clinical trials; to examine the pharmacokinetic characteristics (PK parameters) of single and multiple intravenous infusions of LZM009 in patients with advanced solid tumors, and to examine the production of anti-LZM009 antibodies (ADA) after single and multiple intravenous infusions of LZM009 in patients with advanced solid tumors.

Start Date13 Jun 2018

Sponsor / Collaborator

Livzon MABPharm Inc.

100 Clinical Results associated with LZM-009(Livzon Group Livzon Pharmaceutical Factory)

100 Translational Medicine associated with LZM-009(Livzon Group Livzon Pharmaceutical Factory)

100 Patents (Medical) associated with LZM-009(Livzon Group Livzon Pharmaceutical Factory)

100 Deals associated with LZM-009(Livzon Group Livzon Pharmaceutical Factory)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
thymic carcinoma	Phase 2	China	Livzon MABPharm Inc.	02 Apr 2020
Thymoma	Phase 2	China	Livzon MABPharm Inc.	02 Apr 2020
Non-Small Cell Lung Cancer	Phase 1	China	Livzon MABPharm Inc.	04 Dec 2019
Advanced Malignant Solid Neoplasm	Phase 1	United States	Livzon Pharmaceutical Group, Inc.	21 Aug 2017

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