Fair Oaks

Researchers are conducting a phase 1, multicenter, nonrandomized, open-label, first-in-human study to evaluate YL201 in patients with advanced solid tumors. The study is taking place in China and the United States and consists of two parts: a dose escalation phase to determine the maximum tolerated dose and recommended dose, followed by a dose expansion phase to further assess safety and efficacy. This study targets patients whose tumors are unresponsive to current therapies or who have no standard treatment options available. Participants will receive YL201 through intravenous infusion once every three weeks as a treatment cycle. In some groups, YL201 is administered alone, while in others it is combined with atezolizumab on the first day of each 21-day cycle. The dose escalation phase involves careful monitoring to identify dose-limiting toxicities. The dose expansion phase will enroll patients at the established dose to better define safety and evaluate responses, including in prostate cancer and other solid tumors. Throughout the study, participants will undergo regular assessments including laboratory tests, evaluation of tumor response using RECIST criteria, and monitoring of adverse events. Researchers will track the occurrence of dose-limiting toxicities during the first treatment cycle and overall safety up to approximately 36 months. They will also measure prostate-specific antigen response rates in prostate cancer patients and objective response rates in other solid tumors. Participants must comply with scheduled visits and procedures during the study period.

A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.