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Drug Highest PhasePhase 2/3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价重组人源淋巴细胞激活基因-3(hLAG-3)融合蛋白(EOC202)注射液联合白蛋白紫杉醇在激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的内分泌治疗进展的晚期乳腺癌患者中的安全性和疗效的II期临床研究
[Translation] To evaluate the progress of endocrine therapy with recombinant human lymphocyte activation gene-3 (hLAG-3) fusion protein (EOC202) injection combined with nab-paclitaxel in hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative Phase II clinical study of safety and efficacy in patients with advanced breast cancer
主要目的:
评价EOC202联合白蛋白紫杉醇较白蛋白紫杉醇单药治疗HR阳性、HER2阴性的晚期乳腺癌患者的无进展生存期(PFS)(实体瘤疗效评价标准RECIST 1.1);
次要目的:
1) 评价EOC202联合白蛋白紫杉醇较白蛋白紫杉醇单药治疗HR阳性、HER2阴性的晚期乳腺癌的其他疗效指标,如客观缓解率(ORR)、疾病控制率(DCR)、临床获益率(CBR)及总生存期(OS);
2) 评价EOC202联合白蛋白紫杉醇治疗的安全性;
3) 评价EOC202联合白蛋白紫杉醇治疗的免疫原性;
4) 评价药效动力学(PD)标记物(Interferon-γ、 CXCL-10)变化水平。
探索性目的:
探索EOC202联合白蛋白紫杉醇组受试者血液基线水平可溶性MHC-II配体(淋巴细胞激活基因-3(Lag-3)和纤维蛋白相关抗原(FGL-1))与安全性、疗效、PD和抗药物抗体(ADA)的相关性。
[Translation] main purpose:
To evaluate the progression-free survival (PFS) of EOC202 combined with nab-paclitaxel compared with nab-paclitaxel monotherapy in patients with HR-positive, HER2-negative advanced breast cancer (RECIST 1.1);
Secondary purpose:
1) To evaluate other efficacy indicators of EOC202 combined with nab-paclitaxel compared with nab-paclitaxel alone in the treatment of HR-positive, HER2-negative advanced breast cancer, such as objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR) ) and overall survival (OS);
2) To evaluate the safety of EOC202 combined with nab-paclitaxel;
3) To evaluate the immunogenicity of EOC202 combined with nab-paclitaxel;
4) Evaluate the level of changes in pharmacodynamic (PD) markers (Interferon-γ, CXCL-10).
Exploratory Purpose:
To explore the relationship between the blood baseline level of soluble MHC-II ligands (lymphocyte activation gene-3 (Lag-3) and fibrin-related antigen (FGL-1)) and the safety, efficacy, PD and Correlation of anti-drug antibodies (ADA).
EOC202联合紫杉醇治疗在中国转移性乳腺癌患者中的安全性、耐受性、药代动力学以及药效动力学的I期临床试验
[Translation] Phase I clinical trial of safety, tolerability, pharmacokinetics and pharmacodynamics of EOC202 combined with paclitaxel in Chinese patients with metastatic breast cancer
在中国转移性乳腺癌患者中,评估EOC202皮下注射联合紫杉醇静脉滴注治疗的安全性和耐受性、药代动力学和药效动力学特征、免疫原性特征、初步抗肿瘤疗效以及探索EOC202的免疫原性与药效动力学的相关性。
[Translation] To evaluate the safety and tolerability, pharmacokinetic and pharmacodynamic characteristics, immunogenicity characteristics, preliminary antitumor efficacy of EOC202 subcutaneous injection combined with intravenous infusion of paclitaxel in Chinese patients with metastatic breast cancer and to explore EOC202 The correlation between immunogenicity and pharmacodynamics.
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