Phase III Study to Assess Safety and Effectiveness of VB15010 Tablets in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are studying an experimental drug called VB15010, a PARP1 inhibitor, to see if it is safe, tolerable, and has anti-cancer effects in patients with advanced solid tumors. This phase III clinical trial focuses on adults aged 18 to 75 who have progressive cancer confirmed by tissue tests and specific gene mutations related to DNA repair. Participants will receive VB15010 tablets as a monotherapy. This oral drug is given in cycles of 28 days, and researchers will carefully monitor the safety, side effects, and the drugs behavior in the body. The study will track dose-limiting toxicities during the first cycle and observe the drugs maximum blood concentration over about one year. The trial includes patients with various advanced cancers, including breast, prostate, ovarian, pancreatic, biliary, and colorectal cancers. During the study, participants will undergo evaluations for adverse events and serious side effects from the time they consent until 30 days after their last dose. Researchers will also assess tumor response in prostate cancer patients and monitor pharmacokinetics and pharmacodynamics throughout treatment. The total participation time and follow-up will vary depending on individual response, with safety and efficacy measured regularly. The trial is sponsored by Zhejiang Yangli Pharmaceutical Technology Co., Ltd.

Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors