[Translation] A multicenter, open-label, phase Ib/IIa clinical study: a dose-exploration and expansion study of ILB-2109 tablets combined with toripalimab injection in patients with advanced malignant solid tumors
本研究递增阶段的主要目的是评价ILB-2109片联合特瑞普利单抗注射液治疗晚期恶性实体瘤患者的安全性、耐受性以及确定ILB-2109片联合特瑞普利单抗注射液治疗晚期恶性实体瘤患者的II期推荐剂量;次要目的是评价ILB-2109片联合特瑞普利单抗注射液的药代动力学特征以及初步评价ILB-2109片联合特瑞普利单抗注射液治疗晚期恶性实体瘤患者的有效性。扩展阶段的主要目的是初步研究ILB-2109片联合特瑞普利单抗注射液治疗晚期恶性实体瘤患者,如三阴性乳腺癌、头颈鳞癌(包括不适合手术或放疗的局部晚期以及复发转移的喉癌、口腔癌、口咽癌和下咽癌)、宫颈癌、卵巢癌、子宫内膜癌等的有效性;次要目的是评价ILB-2109片联合特瑞普利单抗注射液在晚期恶性实体瘤患者中的安全性以及评价ILB-2109片联合特瑞普利单抗注射液的药代动力学特征。
[Translation] The primary objective of the escalation phase of this study is to evaluate the safety and tolerability of ILB-2109 tablets combined with toripalimab injection in the treatment of patients with advanced malignant solid tumors and to determine the recommended Phase II dose of ILB-2109 tablets combined with toripalimab injection in the treatment of patients with advanced malignant solid tumors; the secondary objective is to evaluate the pharmacokinetic characteristics of ILB-2109 tablets combined with toripalimab injection and to preliminarily evaluate the effectiveness of ILB-2109 tablets combined with toripalimab injection in the treatment of patients with advanced malignant solid tumors. The main purpose of the extension phase is to preliminarily study the effectiveness of ILB-2109 tablets combined with toripalimab injection in the treatment of patients with advanced malignant solid tumors, such as triple-negative breast cancer, head and neck squamous cell carcinoma (including locally advanced and recurrent and metastatic laryngeal cancer, oral cancer, oropharyngeal cancer and hypopharyngeal cancer that are not suitable for surgery or radiotherapy), cervical cancer, ovarian cancer, endometrial cancer, etc.; the secondary purpose is to evaluate the safety of ILB-2109 tablets combined with toripalimab injection in patients with advanced malignant solid tumors and to evaluate the pharmacokinetic characteristics of ILB-2109 tablets combined with toripalimab injection.