[Translation] A Phase Ib/II, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and preliminary antitumor efficacy of the anti-PD-1 and LAG-3 bispecific antibody AK129 in combination with chemotherapy with or without candidolimab in patients with unresectable locally advanced or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma
主要目的:
评估AK129联合化疗联合或不联合卡度尼利单抗在不可手术切除的局部晚期或转移性HER2阴性胃癌或胃食管结合部腺癌患者中的安全性、耐受性。
评估AK129联合化疗联合或不联合卡度尼利单抗在不可手术切除的局部晚期或转移性HER2阴性胃癌或胃食管结合部腺癌患者中的初步抗肿瘤疗效。 次要目的: 评估AK129联合化疗联合或不联合卡度尼利单抗在不可手术切除的局部晚期或转移性 HER2 阴性胃癌或胃食管结合部腺癌患者中的初步抗肿瘤疗效。
评价AK129联合化疗/联合或不联合卡度尼利单抗时的药代动力学(PK)特征。
评价AK129联合化疗/联合或不联合联合卡度尼利单抗时的免疫原性。 探索性目的: 探索AK129在联合化疗/联合或不联合卡度尼利单抗时的药效动力学特征。
探索受试者肿瘤组织中与抗肿瘤疗效相关的潜在生物标志物。
[Translation] Primary objective:
To evaluate the safety and tolerability of AK129 combined with chemotherapy with or without cadunilimab in patients with unresectable locally advanced or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma.
To evaluate the preliminary anti-tumor efficacy of AK129 combined with chemotherapy with or without cadunilimab in patients with unresectable locally advanced or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma. Secondary objective: To evaluate the preliminary anti-tumor efficacy of AK129 combined with chemotherapy with or without cadunilimab in patients with unresectable locally advanced or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma.
To evaluate the pharmacokinetic (PK) characteristics of AK129 in combination with chemotherapy/with or without cadunilimab.
To evaluate the immunogenicity of AK129 in combination with chemotherapy/with or without cadunilimab. Exploratory objective: To explore the pharmacodynamic characteristics of AK129 in combination with chemotherapy/with or without cadunilimab.
Explore potential biomarkers associated with anti-tumor efficacy in the subjects' tumor tissues.