[Translation] An open-label, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SM3321 in the treatment of patients with relapsed/refractory advanced malignancies
剂量递增阶段(Ia)主要研究目的:1.评估 SM3321 在复发/难治性晚期恶性肿瘤患者中的安全性、耐受性。2.确定 SM3321 治疗复发/难治性晚期恶性肿瘤患者的剂量限制性毒性,最大耐受剂量和 II 期推荐剂量。剂量递增阶段(Ia)次要研究目的:1.评估 SM3321 单次给药和多次给药在复发/难治性晚期恶性肿瘤患者中的药代动力学特征。2.评估 SM3321 单次给药和多次给药在复发/难治性晚期恶性肿瘤患者中的免疫原性。3.评估 SM3321 在复发/难治性晚期恶性肿瘤患者中的初步抗肿瘤活性。剂量扩展阶段(Ib)主要研究目的:1.进一步评估 RP2D 剂量下 SM3321 在复发/难治性晚期恶性肿瘤患者中的安全性和初步抗肿瘤活性。剂量扩展阶段(Ib)次要研究目的:1.进一步评估 RP2D 剂量下 SM3321 在复发/难治性晚期恶性肿瘤患者中的 PK 特征。探索性目的(适用于 Ia 期和 Ib 期):1.探索 SM3321 在复发/难治性晚期恶性肿瘤患者中的药效生物标记物特征。
[Translation] Dose escalation phase (Ia) Main study objectives: 1. Evaluate the safety and tolerability of SM3321 in patients with relapsed/refractory advanced malignancies. 2. Determine the dose-limiting toxicity, maximum tolerated dose and Phase II recommended dose of SM3321 in patients with relapsed/refractory advanced malignancies. Dose escalation phase (Ia) Secondary study objectives: 1. Evaluate the pharmacokinetic characteristics of SM3321 in patients with relapsed/refractory advanced malignancies after single and multiple administrations. 2. Evaluate the immunogenicity of SM3321 in patients with relapsed/refractory advanced malignancies after single and multiple administrations. 3. Evaluate the preliminary anti-tumor activity of SM3321 in patients with relapsed/refractory advanced malignancies. Dose expansion phase (Ib) Main study objectives: 1. Further evaluate the safety and preliminary anti-tumor activity of SM3321 in patients with relapsed/refractory advanced malignancies at the RP2D dose. Dose expansion phase (Ib) Secondary study objectives: 1. Further evaluate the PK characteristics of SM3321 in patients with relapsed/refractory advanced malignancies at the RP2D dose. Exploratory objectives (applicable to Phase Ia and Phase Ib): 1. Explore the pharmacodynamic biomarker characteristics of SM3321 in patients with relapsed/refractory advanced malignancies.