[Translation] Evaluating the safety, tolerability and pharmacokinetics of HYD-PEP06 for injection in patients with solid tumors - a single-center, single-arm, single- and multiple-dose Phase I clinical trial
主要目的:评价药物在晚期实体瘤患者中单次给药及多次给药的耐受性和安全性,确定其最大耐受剂量和剂量限制性毒性。 次要目的:初步评价药物在晚期实体瘤患者中的药代动力学特征及有效性。 探索性目的:初步探索药物在人体的免疫原性反应及抗药抗体产生对PK/PD、有效性和安全性的影响;初步探索药物对细胞因子EGF/VEGF的影响。
[Translation] Primary purpose: To evaluate the tolerance and safety of single and multiple administrations of the drug in patients with advanced solid tumors, and to determine its maximum tolerated dose and dose-limiting toxicity. Secondary purpose: To preliminarily evaluate the pharmacokinetic characteristics and efficacy of the drug in patients with advanced solid tumors. Exploratory purpose: To preliminarily explore the effects of the immunogenicity of the drug in the human body and the production of anti-drug antibodies on PK/PD, efficacy and safety; to preliminarily explore the effects of the drug on cytokines EGF/VEGF.