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Drug Highest PhasePhase 2 |
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MechanismFree radicals scavengers |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项在急性缺血性脑卒中(AIS)受试者中评价注射用 LT3001 的安全性和有效性的多中心、随机、双盲、安慰剂平行对照的 II 期临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study evaluating the safety and efficacy of LT3001 for injection in subjects with acute ischemic stroke (AIS)
主要目的:评价多次给予注射用 LT3001 治疗急性缺血性脑卒中(AIS)患者的安全性。
次要目的:评价多次给予注射用 LT3001 治疗急性缺血性脑卒中(AIS)患者的有效性。
[Translation] Primary objective: To evaluate the safety of multiple doses of LT3001 for injection in patients with acute ischemic stroke (AIS).
Secondary objective: To evaluate the efficacy of multiple doses of LT3001 for injection in patients with acute ischemic stroke (AIS).
评价LBL-007联合特瑞普利单抗治疗晚期恶性肿瘤的安全性、耐受性、有效性的多中心Ib/II期临床研究
[Translation] A multicenter phase Ib/II clinical study evaluating the safety, tolerability and efficacy of LBL-007 combined with toripalimab in the treatment of advanced malignant tumors
主要目的:
评价LBL-007联合特瑞普利单抗治疗晚期恶性肿瘤的安全性和耐受性,确定II期推荐剂量;(Ib期)
评价LBL-007联合特瑞普利单抗治疗晚期恶性肿瘤的有效性。(II期)
次要目的:
评价LBL-007联合特瑞普利单抗治疗晚期恶性肿瘤的药代动力学(PK)特征;
评价LBL-007联合特瑞普利单抗治疗晚期恶性肿瘤的免疫原性;
评价LBL-007联合特瑞普利单抗治疗晚期恶性肿瘤的安全性。 探索性目的:
肿瘤组织中淋巴细胞活化基因-3(LAG-3)、程序性死亡受体-配体1(PD-L1)表达与临床疗效的相关性;
外周血LAG-3受体占有(RO)率。
[Translation] main purpose:
To evaluate the safety and tolerability of LBL-007 combined with toripalimab in the treatment of advanced malignant tumors, and to determine the recommended dose for Phase II; (Phase Ib)
To evaluate the efficacy of LBL-007 combined with toripalimab in the treatment of advanced malignant tumors. (Phase II)
Secondary purpose:
To evaluate the pharmacokinetic (PK) characteristics of LBL-007 combined with toripalimab in the treatment of advanced malignant tumors;
To evaluate the immunogenicity of LBL-007 combined with toripalimab in the treatment of advanced malignant tumors;
To evaluate the safety of LBL-007 combined with toripalimab in the treatment of advanced malignant tumors. Exploratory Purpose:
The correlation between the expression of lymphocyte activation gene-3 (LAG-3) and programmed death-ligand 1 (PD-L1) in tumor tissue and clinical efficacy;
Peripheral blood LAG-3 receptor occupancy (RO) rate.
一项评价LBL-007联合特瑞普利单抗或LBL-007联合特瑞普利单抗及阿昔替尼治疗不可切除或转移性黑色素瘤的安全性、耐受性、有效性的多中心I期临床试验
[Translation] A multicenter study to evaluate the safety, tolerability, and efficacy of LBL-007 combined with toripalimab or LBL-007 combined with toripalimab and axitinib in the treatment of unresectable or metastatic melanoma Phase I clinical trial
主要目的
评价LBL-007联合特瑞普利单抗治疗不可切除或转移性黑色素瘤的安全性和耐受性,为后续临床研究提供指导剂量。
评价LBL-007联合特瑞普利单抗及阿昔替尼治疗不可切除或转移性黑色素瘤的安全性和耐受性,为后续临床研究提供指导剂量。
次要目的
评价LBL-007联合特瑞普利单抗治疗不可切除或转移性黑色素瘤的初步有效性;
评价LBL-007联合特瑞普利单抗联及阿昔替尼治疗不可切除或转移性黑色素瘤的初步有效性;
评价LBL-007联合特瑞普利单抗治疗不可切除或转移性黑色素瘤的PK特征;
评价LBL-007联合特瑞普利单抗联及阿昔替尼治疗不可切除或转移性黑色素瘤的PK特征;
评价用药前后LAG-3受体占有率(RO)情况及其与疗效的关系;
评价LBL-007在黑色素瘤患者中的免疫原性 探索性目的
评价用药前后肿瘤组织中淋巴细胞亚群、LAG-3及PD-L1表达及其与疗效的相关性;
评价免疫细胞活化标志物穿孔素或颗粒酶,以及转录因子7(TCF7)与疗效的相关性;
评价用药前后肿瘤组织中VEGF-A表达情况及其与疗效的相关性(LBL-007联合特瑞普利单抗及阿昔替尼组适用)。
[Translation] main purpose
To evaluate the safety and tolerability of LBL-007 combined with toripalimab in the treatment of unresectable or metastatic melanoma, and to provide guidance for subsequent clinical studies.
To evaluate the safety and tolerability of LBL-007 combined with toripalimab and axitinib in the treatment of unresectable or metastatic melanoma, and to provide guidance for subsequent clinical studies.
secondary purpose
To evaluate the preliminary efficacy of LBL-007 combined with toripalimab in the treatment of unresectable or metastatic melanoma;
To evaluate the preliminary efficacy of LBL-007 combined with toripalimab combined with axitinib in the treatment of unresectable or metastatic melanoma;
To evaluate the PK profile of LBL-007 combined with toripalimab in the treatment of unresectable or metastatic melanoma;
To evaluate the PK characteristics of LBL-007 combined with toripalimab combined with axitinib in the treatment of unresectable or metastatic melanoma;
To evaluate the LAG-3 receptor occupancy rate (RO) and its relationship with efficacy before and after treatment;
To evaluate the immunogenicity of LBL-007 in patients with melanoma Exploratory Purpose
To evaluate the expression of lymphocyte subsets, LAG-3 and PD-L1 in tumor tissue before and after treatment and their correlation with curative effect;
To evaluate the correlation of immune cell activation markers perforin or granzyme, and transcription factor 7 (TCF7) with efficacy;
The expression of VEGF-A in tumor tissue before and after treatment and its correlation with curative effect were evaluated (applicable to LBL-007 combined with toripalimab and axitinib group).
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