Delving into the Latest Updates on QBH-196 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

c-Met

Mechanism

c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Shenyang Pharmaceutical University

Active Organization

Shenyang Pharmaceutical University

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationSpecial Review Project (CN)

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主要目的：评价 QBH-196 治疗标准治疗失败的晚期恶性实体瘤患者的安全性和耐受性，并探索QBH-196 的最大耐受剂量（ MTD），确定Ⅱ期临床试验推荐剂量（ RP2D）。次要目的： 1）评价 QBH-196 的药代动力学（ PK）特征； 2）初步评价 QBH-196 的抗肿瘤疗效； 3）如数据允许，初步评价生物标志物（如 c-MET 异常等）与抗肿瘤疗效的关系。

[Translation]

Primary objective: To evaluate the safety and tolerability of QBH-196 in patients with advanced malignant solid tumors who have failed standard treatment, and to explore the maximum tolerated dose (MTD) of QBH-196 and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of QBH-196; 2) To preliminarily evaluate the anti-tumor efficacy of QBH-196; 3) If data permit, to preliminarily evaluate the relationship between biomarkers (such as c-MET abnormalities, etc.) and anti-tumor efficacy.

Start Date-

Sponsor / Collaborator

Shenyang Pharmaceutical University

CTR20213068

/ RecruitingPhase 1

评价多靶点激酶抑制剂 QBH-196 治疗晚期恶性实体瘤患者的安全性、耐受性、药代动力学特征的剂量递增、开放的Ⅰ期临床试验

[Translation] A dose-escalation, open-label phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of the multi-target kinase inhibitor QBH-196 in the treatment of patients with advanced malignant solid tumors

主要目的：评价 QBH-196 治疗标准治疗失败的晚期恶性实体瘤患者的安全性和耐受性，并探索QBH-196 的最大耐受剂量（ MTD），确定Ⅱ期临床试验推荐剂量（ RP2D）。次要目的： 1）评价 QBH-196 的药代动力学（ PK）特征； 2）初步评价 QBH-196 的抗肿瘤疗效； 3）如数据允许，初步评价生物标志物（如 c-MET 异常等）与抗肿瘤疗效的关系。 2、*试验设计

[Translation]

Primary objectives: To evaluate the safety and tolerability of QBH-196 in patients with advanced malignant solid tumors who have failed standard treatment, and to explore the maximum tolerated dose (MTD) of QBH-196 and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of QBH-196; 2) To preliminarily evaluate the anti-tumor efficacy of QBH-196; 3) If data permit, to preliminarily evaluate the relationship between biomarkers (such as c-MET abnormalities, etc.) and anti-tumor efficacy. 2. * Experimental design

Start Date12 Jan 2022

Sponsor / Collaborator

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

CTR20234232

/ RecruitingPhase 1

评价多靶点激酶抑制剂 QBH-196 治疗晚期恶性实体瘤患者的安全性、耐受性、药代动力学特征的剂量递增、开放的Ⅰ期临床试验

[Translation] A dose-escalation, open-label phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of the multi-target kinase inhibitor QBH-196 in the treatment of patients with advanced malignant solid tumors

主要目的：评价 QBH-196 治疗标准治疗失败的晚期恶性实体瘤患者的安全性和耐受性，并探索QBH-196 的最大耐受剂量（MTD），确定Ⅱ期临床试验推荐剂量（RP2D）。次要目的：1）评价 QBH-196 的药代动力学（PK）特征；2）初步评价 QBH-196 的抗肿瘤疗效；3）如数据允许，初步评价生物标志物（如 c-MET 异常等）与抗肿瘤疗效的关系。

[Translation]

Primary objectives: To evaluate the safety and tolerability of QBH-196 in patients with advanced malignant solid tumors who have failed standard treatment, and to explore the maximum tolerated dose (MTD) of QBH-196 and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of QBH-196; 2) To preliminarily evaluate the anti-tumor efficacy of QBH-196; 3) If data permit, to preliminarily evaluate the relationship between biomarkers (such as c-MET abnormalities, etc.) and anti-tumor efficacy.

Start Date12 Jan 2022

Sponsor / Collaborator

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

100 Clinical Results associated with QBH-196

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100 Translational Medicine associated with QBH-196

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100 Patents (Medical) associated with QBH-196

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100 Deals associated with QBH-196

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