[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of live bacteria MNC-168 enteric-coated capsules combined with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors
主要目的:
评价MNC-168分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的安全性和耐受性,确定其最大耐受剂量(MTD)和/或推荐的II期剂量(RP2D)。
次要目的:
1) 评价MNC-168分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的药代动力学特征;
2) 评估MNC-168分别联用帕博利珠单抗、舒格利单抗的初步抗肿瘤疗效,为后续临床研究推荐合适的用药剂量。
[Translation] Primary objective:
To evaluate the safety and tolerability of MNC-168 in combination with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors, and to determine its maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D).
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of MNC-168 in combination with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors;
2) To evaluate the preliminary anti-tumor efficacy of MNC-168 in combination with pembrolizumab and sugemalimab, and to recommend appropriate dosages for subsequent clinical studies.