Zhangzhou

Researchers are evaluating the safety and effectiveness of a drug called GB491 combined with Letrozole compared to a 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 received prior systemic antitumor therapy for this condition. It is a phase III randomized, double-blind, placebo-controlled trial designed to provide important information about treatment options for this group of breast cancer patients. Participants are randomly assigned to one of two groups: one receiving GB491 150 mg orally twice daily plus Letrozole 2.5 mg orally once daily, and the other receiving a placebo orally twice daily plus Letrozole 2.5 mg orally once daily. Treatment cycles last 28 days, starting from the first day of cycle 1. The study compares the combined treatment effects over time, focusing on progression-free survival and safety outcomes. Throughout the study, researchers will monitor participants for progression-free survival using established criteria for about 60 months. They will also assess safety and organ function, with required laboratory tests and clinical evaluations. Participants must meet specific eligibility criteria at the start and provide informed consent. The study aims to gather detailed data on how well the treatments work and their safety profiles over the extended follow-up period.

Researchers are evaluating the safety and tolerability of intravesical FL115 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 when used with BCG and to assess the early effectiveness of FL115 alone or with BCG. This trial includes phases Ia, Ib, and II, focusing on dose escalation and cohort expansion in NMIBC patients who have high-grade disease unresponsive to BCG treatment. Participants receive FL115 either as a single agent or combined with intravesical BCG through three treatment periods: induction, enhanced induction or maintenance 1, and maintenance 2. The study evaluates FL115 dose escalation alone (Phase Ia), FL115 plus BCG dose escalation (Phase Ib), and FL115 plus BCG cohort expansion (Phase II). Treatments are administered directly into the bladder to target cancer cells locally. During the study, participants are monitored for safety, tolerability, and anti-tumor activity up to 5 years. Key outcomes include maximum tolerated dose, recommended phase 2 dose, complete response at 36 months, and disease-free rates at 12 months. Patients undergo regular assessments including safety evaluations, pharmacokinetics, and cancer response measurements throughout the study duration.