[Translation] A phase I/IIa, open-label trial evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of AZD7789 anti-PD-1/anti-TIM-3 bispecific antibody in subjects with advanced or metastatic solid tumors Sexuality, dose escalation, and dose expansion studies
主要目的:
A部分(剂量递增)和中国迷你剂量递增期:评估晚期或转移性实体瘤受试者中AZD7789的安全性和耐受性,鉴定其剂量限制性毒性(DLT)特征,以及确定最大耐受剂量(MTD)或最佳生物学剂量(OBD)以及推荐的II期研究剂量(RP2D)。
B部分(剂量扩展):评估晚期或转移性实体瘤受试者中AZD7789的安全性和耐受性;评估晚期或转移性实体瘤受试者中AZD7789的初步抗肿瘤作用
次要目的:
评估晚期或转移性实体瘤患者中AZD7789的药代动力学(PK);评估晚期或转移性实体瘤患者中AZD7789的免疫原性
A部分(剂量递增)和中国迷你剂量递增期:评估晚期或转移性实体瘤受试者中AZD7789的初步抗肿瘤作用
B部分(剂量扩展):进一步评估晚期或转移性实体瘤患者中AZD7789的初步抗肿瘤作用
[Translation] main purpose:
Part A (Dose Escalation) and China Mini Dose Escalation Phase: To evaluate the safety and tolerability of AZD7789 in subjects with advanced or metastatic solid tumors, to characterize its dose-limiting toxicity (DLT), and to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) and recommended phase II study dose (RP2D).
Part B (Dose Expansion): To evaluate the safety and tolerability of AZD7789 in subjects with advanced or metastatic solid tumors; to evaluate the preliminary anti-tumor effect of AZD7789 in subjects with advanced or metastatic solid tumors
Secondary purpose:
To evaluate the pharmacokinetics (PK) of AZD7789 in patients with advanced or metastatic solid tumors; to evaluate the immunogenicity of AZD7789 in patients with advanced or metastatic solid tumors
Part A (Dose Escalation) and China Mini-Dose Escalation Phase: Evaluation of the Preliminary Anti-Tumor Effect of AZD7789 in Subjects with Advanced or Metastatic Solid Tumors
Part B (Dose Expansion): Further evaluation of the preliminary anti-tumor effect of AZD7789 in patients with advanced or metastatic solid tumors