[Translation] A Phase 1 clinical study of the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of QLF3108 for injection in patients with advanced solid tumors
1a期:剂量递增和PK扩展
主要研究目的:评价注射用QLF3108单次及多次给药治疗晚期实体瘤患者的安全性和耐受性,确定2期推荐剂量(RP2D)。
次要研究目的:评价注射用QLF3108单次及多次给药后的药代动力学(PK)特征、免疫原性、初步有效性。
1b期:单药疗效扩展
主要研究目的:评价注射用QLF3108单药治疗晚期实体瘤患者的初步疗效。
次要研究目的:评价注射用QLF3108单药治疗晚期实体瘤患者的安全性、PK特性、免疫原性。
[Translation] Phase 1a: Dose escalation and PK expansion
Main study objectives: To evaluate the safety and tolerability of single and multiple administrations of QLF3108 for injection in patients with advanced solid tumors, and to determine the recommended dose for Phase 2 (RP2D).
Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics, immunogenicity, and preliminary efficacy of QLF3108 for injection after single and multiple administrations.
Phase 1b: Single-drug efficacy expansion
Main study objectives: To evaluate the preliminary efficacy of QLF3108 for injection as a monotherapy in patients with advanced solid tumors.
Secondary study objectives: To evaluate the safety, PK characteristics, and immunogenicity of QLF3108 for injection as a monotherapy in patients with advanced solid tumors.