Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

To evaluate the safety, tolerability and pharmacokinetic characteristics of sufenidone tablets after repeated administration in healthy adult volunteers

Phase I (Dose Escalation Phase): Primary Objectives: - To evaluate the safety and tolerability of SC0245 monotherapy in patients with advanced malignant solid tumors; - To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) or Phase II recommended dose (RP2D) of SC0245. Secondary Objectives: - To evaluate the pharmacokinetic (PK) characteristics of SC0245 monotherapy in patients with advanced malignant solid tumors; - To evaluate the preliminary anti-tumor activity of SC0245 monotherapy in patients with advanced malignant solid tumors. Phase II (Dose Expansion Phase) Primary Objectives: To further evaluate the safety and tolerability of SC0245 monotherapy in patients with advanced malignant solid tumors. Secondary Objectives: - To further preliminarily evaluate the anti-tumor activity of SC0245 monotherapy in patients with advanced malignant solid tumors in multiple specific tumor types. - To further explore the relationship between biomarkers and clinical efficacy.

Primary objectives: - To evaluate the occurrence of DLT of SC0191 tablets alone in patients with advanced malignant solid tumors (dose escalation phase); - To determine the recommended dose (RP2D) of SC0191 tablets alone in Phase II clinical trials (dose escalation phase); - To evaluate the safety and tolerability of SC0191 tablets alone in patients with advanced malignant solid tumors; Secondary objectives: - To evaluate the pharmacokinetic (PK) characteristics of SC0191 tablets alone in patients with advanced malignant solid tumors; - To evaluate the preliminary anti-tumor activity of SC0191 tablets alone in patients with advanced malignant solid tumors.