[Translation] A Phase I/II clinical study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of IMM040811 injection in combination with IMM092 injection in patients with advanced solid tumors.
主要目的:评价IMM040811注射液和IMM092注射液联合/不联合多西他赛注射液在晚期实体瘤受试者中的安全性和耐受性,确定II期推荐剂量(RP2D);采用实体瘤疗效评价标准1.1版(RECIST V1.1)初步评价IMM040811注射液和IMM092注射液联合/不联合多西他赛注射液的抗肿瘤有效性。次要目的:评价IMM040811注射液联合IMM092注射液的药代动力学特征、免疫原性;采用实体瘤疗效评价标准1.1版(RECIST V1.1)初步评价IMM040811注射液和IMM092注射液联合/不联合多西他赛注射液的抗肿瘤有效性。探索性目的:采用iRECIST标准探索性评价IMM040811注射液和IMM092注射液联合不联合多西他赛注射液的抗肿瘤活性;探索IMM040811注射液联合IMM092注射液的药效学特征。
[Translation] Primary Objective: To evaluate the safety and tolerability of IMM040811 injection and IMM092 injection, in combination with or without docetaxel injection, in patients with advanced solid tumors, and to determine the Phase II recommended dose (RP2D). To preliminarily evaluate the antitumor efficacy of IMM040811 injection and IMM092 injection, in combination with or without docetaxel injection, using RECIST version 1.1. Secondary Objectives: To evaluate the pharmacokinetic characteristics and immunogenicity of IMM040811 injection and IMM092 injection, in combination with or without docetaxel injection, using RECIST version 1.1. Exploratory objective: To evaluate the antitumor activity of IMM040811 injection and IMM092 injection in combination with or without docetaxel injection using iRECIST criteria; and to explore the pharmacodynamic characteristics of IMM040811 injection in combination with IMM092 injection.