Study of Purinostat Mesylate Injection in Combination Therapy for Advanced Solid Tumors Evaluating Safety, Tolerability, and Early Effectiveness in Adults

What this Trial Is About

Researchers are evaluating Purinostat Mesylate in combination therapies for patients with advanced solid tumors, including breast cancer and other solid tumor types. The study aims to assess safety, tolerability, dose limits, and preliminary effectiveness of Purinostat Mesylate given with other treatments like fulvestrant or tislelizumab. The trial includes both Phase Ib dose-escalation and Phase IIa expansion phases to better understand how these therapies work in patients without other standard treatment options. Participants receive different doses of Purinostat Mesylate by intravenous infusion, either alone or combined with fulvestrant or tislelizumab, given in cycles of 21 or 28 days depending on the group. The study includes several groups breast cancer patients receiving Purinostat Mesylate alone or with fulvestrant, and patients with various advanced solid tumors receiving Purinostat Mesylate alone or with tislelizumab. Dose escalation occurs gradually with monitoring for side effects and safety to find the best dose for further study. During the trial, participants undergo regular assessments including tumor measurements and safety tests to track treatment effects and side effects up to 96 weeks. Researchers will evaluate outcomes such as the rate of tumor remission, disease control, survival times, and duration of response. Participants also have their organ function and laboratory values monitored, with ongoing safety follow-up throughout the study period. The trial spans from initial treatment up to nearly two years to gather detailed data on treatment impact and tolerability.

A Clinical Study of Purinostat Mesylate for Injection in Patients With Advanced Solid Tumors