[Translation] An open-label, single-arm, multicenter phase Ib/II clinical study to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of RC108 combined with toripalimab in patients with advanced solid tumors expressing c-Met
第一阶段(Ⅰb期剂量递增阶段)研究主要目的:评价 RC108 联合特瑞普利单抗在 c-Met 表达的晚期实体瘤患者中的安全性、耐受性。确定 RC108 联合特瑞普利单抗在 c-Met 表达的晚期实体瘤患者中的 II 期推荐剂量(RP2D)和/或最大耐受剂量(MTD)。
第二阶段(Ⅱ期剂量扩展阶段)研究主要目的:评价 RC108 联合特瑞普利单抗在 c-Met 表达的晚期实体瘤(包括不限于腺样囊性癌、消化系统恶性肿瘤、头颈部鳞状细胞癌、非小细胞肺癌、透明细胞或乳头状肾细胞癌、三阴乳腺癌、卵巢癌、去势抵抗性前列腺癌及甲状腺癌等其他可能获益的癌种)患者中的有效性和安全性。
[Translation] The main purpose of the Phase I (Phase Ib dose escalation phase) study is to evaluate the safety and tolerability of RC108 combined with Teplizumab in patients with advanced solid tumors expressing c-Met. To determine the Phase II recommended dose (RP2D) and/or maximum tolerated dose (MTD) of RC108 combined with Teplizumab in patients with advanced solid tumors expressing c-Met.
The main purpose of the Phase II (Phase II dose expansion phase) study is to evaluate the efficacy and safety of RC108 combined with Teplizumab in patients with advanced solid tumors expressing c-Met (including but not limited to adenoid cystic carcinoma, digestive system malignancies, head and neck squamous cell carcinoma, non-small cell lung cancer, clear cell or papillary renal cell carcinoma, triple-negative breast cancer, ovarian cancer, castration-resistant prostate cancer, thyroid cancer and other cancers that may benefit).