Zhangzhou

Researchers are evaluating the efficacy and safety of GB491 combined with Letrozole compared to placebo combined with Letrozole in treating patients with hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2- locally advanced or metastatic breast cancer. This study focuses on patients who have not previously received systemic antitumor therapy for this condition and aims to provide new treatment insights. Participants are randomly assigned to one of two groups one receives GB491 at 150 mg orally twice daily along with Letrozole 2.5 mg orally once daily, while the other receives a placebo twice daily with the same Letrozole dose. Treatment cycles last 28 days, and the study is designed as a randomized, double-blind, placebo-controlled phase III trial. During the study, participants will be closely monitored for progression-free survival assessed by investigators using RECIST v1.1 criteria over approximately 60 months. Additional measures include overall survival, response rates, duration of response, disease control rates, clinical benefit rates, and the frequency and severity of adverse events. Regular assessments ensure safety and treatment adherence throughout the study period.

Researchers are evaluating the safety and tolerability of the drug FL115, given alone or combined with BCG, in patients with non-muscle invasive bladder cancer NMIBC. The study aims to find the recommended phase 2 dose RP2D of FL115 with BCG and to explore its preliminary effectiveness. The trial includes three parts FL115 alone dose escalation, FL115 with BCG dose escalation, and a cohort expansion of FL115 with BCG treatment. Participants receive FL115 intravesically either alone or with BCG through three treatment periods induction, enhanced induction or maintenance 1, and maintenance 2. These treatment schedules are designed to assess the drug doses and combination effects systematically. The study involves dose escalation phases followed by a cohort expansion phase to further evaluate safety and anti-tumor activity. Individuals in the study will be closely monitored with safety and tolerability assessments up to 5 years, and primary outcomes include maximum tolerated dose MTD, RP2D, complete response at 36 months, and disease-free rate at 12 months. Participants undergo required procedures and follow-ups to assess drug effects and health status. The study aims to provide thorough data on FL115s safety and potential anti-cancer activity over several years.