[Translation] Phase I open-label, dose-escalation, and expansion-stage clinical study evaluating the safety, tolerability, and pharmacokinetics of LYC001 monotherapy in subjects with advanced solid tumors
Ia期剂量递增阶段
主要目的:
1) 评价LYC001在晚期实体瘤受试者中的安全性和耐受性;
2) 确定最大耐受剂量(MTD,若存在)和/或扩展阶段推荐剂量(RDE)。
次要目的:
1) 评价LYC001在晚期实体瘤受试者中的药代动力学特征;
2) 评价LYC001在晚期实体瘤受试者中的免疫原性。 Ib期扩展阶段
主要目的:
1) 评价在RDE剂量下LYC001在晚期实体瘤受试者中的安全性和耐受性;
2) 确定后续II期临床研究的推荐剂量(RP2D)。
次要目的:
1) 评价在RDE剂量下LYC001在晚期实体瘤受试者中的药代动力学特征;
2) 评价LYC001在晚期实体瘤受试者中的免疫原性;
3) 评价在RDE剂量下LYC001给药晚期实体瘤受试者的初步有效性。
[Translation] Phase Ia Dose-Escalation Phase
Primary Objectives:
1) Evaluate the safety and tolerability of LYC001 in subjects with advanced solid tumors;
2) Determine the maximum tolerated dose (MTD, if available) and/or recommended dose for expansion (RDE).
Secondary Objectives:
1) Evaluate the pharmacokinetic profile of LYC001 in subjects with advanced solid tumors;
2) Evaluate the immunogenicity of LYC001 in subjects with advanced solid tumors. Phase Ib Extension Phase
Primary Objectives:
1) Evaluate the safety and tolerability of LYC001 at the RDE dose in subjects with advanced solid tumors;
2) Determine the recommended dose (RP2D) for subsequent Phase II clinical studies.
Secondary Objectives:
1) Evaluate the pharmacokinetic profile of LYC001 at the RDE dose in subjects with advanced solid tumors;
2) Evaluate the immunogenicity of LYC001 in subjects with advanced solid tumors;
3) Evaluate the preliminary efficacy of LYC001 at the RDE dose in subjects with advanced solid tumors.