Hangzhou Wutong Tree Pharmaceutical Co., Ltd.

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.

Main objectives 1. To evaluate the safety and tolerability of WTS-005 tablets in patients with advanced solid tumors. 2. To determine the maximum tolerated dose (MTD) and the recommended dose for phase II (RP2D). Secondary objectives 1. To evaluate the preliminary anti-tumor efficacy of WTS-005 tablets. 2. To evaluate the pharmacokinetic characteristics of WTS-005 tablets in patients with advanced solid tumors.

Main purpose Dose escalation phase: 1. Evaluate the safety and tolerability of WTS-004 in patients with EGFR mutation-positive advanced non-small cell lung cancer who have progressed after adequate EGFR-TKI treatment and have progressed after at least platinum-containing chemotherapy or are intolerant to platinum-containing treatment. 2. Determine the maximum tolerated dose (MTD). Dose expansion phase: 1. Evaluate the safety of WTS-004 in patients with EGFR mutation-positive advanced non-small cell lung cancer with central nervous system (CNS) metastasis as the primary cause of disease progression after EGFR-TKI treatment. 2. Determine the recommended dose for Phase II (RP2D). Secondary purpose 1. Evaluate the pharmacokinetic characteristics of WTS-004 tablets in patients with advanced non-small cell lung cancer; 2. Evaluate the preliminary anti-tumor activity of WTS-004 tablets in patients with advanced non-small cell lung cancer. Exploratory purpose Dose expansion phase: Explore the efficacy of WTS-004 on extracranial lesions in patients with advanced non-small cell lung cancer.