Phase I Study of Oral YY201 to Assess Safety and Early Effectiveness in Adults With Advanced Solid Tumors or Blood Cancers

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics, and preliminary anti-tumor effects of YY201 in patients with advanced solid tumors and blood cancers who have relapsed or are refractory to standard treatments. This phase I, open-label, multicenter study focuses on patients who cannot tolerate or have failed standard care, aiming to find a suitable dose and explore how the drug works in these conditions. The study has two phases a dose escalation phase to determine the maximum tolerated dose or recommended dose for further studies, and a dose expansion phase to evaluate the anti-tumor activity of YY201. Participants will receive YY201 orally under fasting conditions, either as a single dose or once daily in multiple doses. Specific patient groups in the expansion phase include those with advanced solid tumors sensitive to STAT3 therapy, peripheral T-cell lymphoma with STAT3 mutation, and relapsedrefractory acute myeloid leukemia. Participants will undergo regular assessments including safety monitoring, laboratory tests, and tumor evaluations to measure responses and side effects. Primary outcomes include dose limiting toxicities, maximum tolerated dose, and treatment-emergent adverse events during up to 24 months. Secondary measures track drug concentration in blood, response duration, time to response, and overall survival. The study requires participants to be aged 18 to 80 years and able to comply with all procedures throughout the study period.

An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of YY201 in Patients With Advanced Solid Tumors and Hematological Malignancies