YY-201 (Shanghai Yuyao)

The main purpose of the dose escalation phase is to evaluate the safety and tolerability of YY201 in patients with advanced solid tumors and relapsed and refractory hematological malignancies, and to observe possible dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) and/or the recommended dose (RP2D) for Phase II clinical trials. Secondary purpose: to evaluate the pharmacokinetic (PK) characteristics and preliminary efficacy of YY201 in patients with advanced solid tumors and relapsed and refractory hematological malignancies. Exploratory purpose: to explore the relationship between biomarkers and efficacy. The main purpose of the dose expansion phase is to evaluate the safety and tolerability of YY201, as well as the preliminary efficacy, in patients with solid tumors (including triple-negative breast cancer, pancreatic cancer, head and neck squamous cell carcinoma, etc.) and relapsed and refractory hematological malignancies (including acute myeloid leukemia) and peripheral T-cell lymphoma who have failed standard treatment or have no standard treatment. Secondary purpose: To evaluate the PK characteristics of YY201 in patients with solid tumors (including triple-negative breast cancer, pancreatic cancer, head and neck squamous cell carcinoma, etc.) and relapsed and refractory hematological malignancies (including acute myeloid leukemia) and peripheral T-cell lymphoma who have failed or have no standard treatment. Exploratory purpose: To explore the relationship between biomarkers and efficacy.