[Translation] An open-label, multicenter Phase II clinical study of the safety, tolerability, and efficacy of HRS-4508 combined with other anti-tumor therapies in subjects with non-small cell lung cancer
1.评价HRS-4508联合其他抗肿瘤治疗在非小细胞肺癌患者中的安全性、耐受性,确定联合治疗的疗效拓展阶段的推荐剂量(RP2D);
2.评价HRS-4508联合其他抗肿瘤治疗在非小细胞肺癌患者中的客观缓解率(ORR);
3.评价HRS-4508、SHR-A1811游离毒素的药代动力学(PK)特征;
4.评价HRS-4508联合其他抗肿瘤治疗在非小细胞肺癌患者中的其他疗效终点,包括:疾病控制率(DCR)、缓解持续时间(DoR)、无进展生存期(PFS)、总生存期(OS)
[Translation] 1. Evaluate the safety and tolerability of HRS-4508 in combination with other anti-cancer therapies in patients with non-small cell lung cancer (NSCLC) and determine the recommended dose for the efficacy expansion phase (RP2D) of the combination therapy;
2. Evaluate the objective response rate (ORR) of HRS-4508 in combination with other anti-cancer therapies in patients with NSCLC;
3. Evaluate the pharmacokinetic (PK) characteristics of the free toxins of HRS-4508 and SHR-A1811;
4. Evaluate other efficacy endpoints of HRS-4508 in combination with other anti-cancer therapies in patients with NSCLC, including disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).