[Translation] A multicenter, open-label, dose-escalation and dose-expansion Phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamic characteristics, immunogenicity and preliminary efficacy of TWP-102 injection in patients with advanced malignant tumors
主要目的:
a. 评估TWP-102注射液在晚期恶性肿瘤受试者中的安全性和耐受性;
b. 通过剂量限制性毒性(DLT)的发生率,确定TWP-102注射液在晚期恶性肿瘤受试者中最大耐受剂量(MTD);
次要目的:
a. 评估TWP-102注射液在晚期恶性肿瘤受试者中的药代动力学特征;
b. 评估TWP-102注射液在晚期恶性肿瘤受试者中的药效动力学特征;
c. 评估TWP-102注射液在晚期恶性肿瘤受试者中的免疫原性;
d. 采用实体瘤疗效评价标准(RECIST)v1.1评估TWP-102注射液在晚期实体瘤受试者中的初步抗肿瘤活性;采用2014版Lugano评价标准评估TWP-102注射液在非霍奇金淋巴瘤受试者中的的初步抗肿瘤活性。
探索性目的:
a. 采用免疫治疗实体瘤疗效评价标准(iRECIST)标准探索性评估TWP-102注射液在晚期实体瘤受试者中的初步抗肿瘤活性;
b. 探索检测TWP-102注射液治疗晚期恶性肿瘤疗效的生物标志物。
[Translation] Primary objectives:
a. To evaluate the safety and tolerability of TWP-102 injection in subjects with advanced malignant tumors;
b. To determine the maximum tolerated dose (MTD) of TWP-102 injection in subjects with advanced malignant tumors by the incidence of dose-limiting toxicity (DLT);
Secondary objectives:
a. To evaluate the pharmacokinetic characteristics of TWP-102 injection in subjects with advanced malignant tumors;
b. To evaluate the pharmacodynamic characteristics of TWP-102 injection in subjects with advanced malignant tumors;
c. To evaluate the immunogenicity of TWP-102 injection in subjects with advanced malignant tumors;
d. To evaluate the preliminary antitumor activity of TWP-102 injection in subjects with advanced solid tumors using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; and to evaluate the preliminary antitumor activity of TWP-102 injection in subjects with non-Hodgkin's lymphoma using the 2014 version of the Lugano evaluation criteria.
Exploratory purpose:
a. To explore the preliminary anti-tumor activity of TWP-102 injection in subjects with advanced solid tumors using the immunotherapy efficacy evaluation criteria in solid tumors (iRECIST) standard;
b. To explore biomarkers for detecting the efficacy of TWP-102 injection in the treatment of advanced malignant tumors.