[Translation] A phase I/II clinical study on the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 injection in patients with advanced malignant tumors
主要研究目的: 评估SHR-3276注射液在晚期恶性肿瘤患者中的安全性和耐受性,确定最大耐受剂量(MTD)或最大给药剂量(MAD)以及SHR-3276的II期临床研究推荐剂量(RP2D)。 次要研究目的: 评估SHR-3276注射液在晚期恶性肿瘤患者中的药代动力学(PK)特征、药效动力学(PD)特征、免疫原性与初步疗效。
探索性研究目的: 探索晚期恶性肿瘤患者中的疗效预测生物标志物。
[Translation] Primary study objectives: To evaluate the safety and tolerability of SHR-3276 injection in patients with advanced malignant tumors, determine the maximum tolerated dose (MTD) or maximum dose (MAD) and the recommended dose (RP2D) for Phase II clinical studies of SHR-3276. Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity and preliminary efficacy of SHR-3276 injection in patients with advanced malignant tumors.
Exploratory study objectives: To explore efficacy predictive biomarkers in patients with advanced malignant tumors.