Wuxi Heyu Biomedical Technology Co., Ltd.

To evaluate the safety and tolerability of ABSK051 as a monotherapy and in combination with tislelizumab in patients with advanced solid tumors.

Main objectives 1. Evaluate the safety, tolerability and maximum tolerated dose (MTD)/recommended extended dose (RDE) of ABSK121-NX in patients with advanced solid tumors 2. Determine the recommended phase 2 dose (RP2D) of ABSK121-NX Secondary objectives 1. Investigate the pharmacokinetic (PK) characteristics of ABSK121-NX 2. Evaluate the preliminary anti-tumor activity of ABSK121-NX Exploratory objectives 1. Evaluate any potential high-proportion metabolites of ABSK121-NX 2. Investigate the pharmacodynamic (PD) characteristics of ABSK121-NX 3. Explore tissue or blood biomarkers associated with clinical activity 4. Preliminary evaluation of the effect of food on ABSK121-NX

Part A: Primary objective: To evaluate the safety and tolerability of AZD4547 combined with tislelizumab in the treatment of patients with locally advanced or metastatic urothelial carcinoma; to confirm the dose and mode of clinical study combination therapy in Part B. Secondary objective: To preliminarily evaluate the anti-tumor activity of AZD4547 combined with tislelizumab in the treatment of locally advanced or metastatic urothelial carcinoma; to evaluate the PK characteristics of AZD4547 combined with tislelizumab after continuous administration. Exploratory objective: To explore the PD characteristics of AZD4547 and the correlation between PD and PK: Part B: Primary objective: To evaluate the anti-tumor activity of AZD4547 combined with tislelizumab in the treatment of patients with locally advanced or metastatic urothelial carcinoma with FGFR2/3 alterations. Secondary objectives: To evaluate the other anti-tumor activities of AZD4547 combined with tislelizumab in the treatment of patients with locally advanced or metastatic urothelial carcinoma with FGFR2/3 alterations; to evaluate the safety and tolerability of AZD4547 combined with tislelizumab in the treatment of patients with locally advanced or metastatic urothelial carcinoma with FGFR2/3 alterations; to evaluate the pharmacokinetic characteristics of AZD4547; Exploratory objectives: To explore the PD characteristics of AZD4547 and the correlation between PD and PK; the relationship between anti-tumor efficacy and the immune and genomic characteristics of the tumor microenvironment; to explore the efficacy of AZD4547 combined with tislelizumab in the treatment of patients with locally advanced or metastatic urothelial carcinoma with FGFR2/3 alterations.