Phase III Study of HH2853 Oral Treatment for Safety and Effectiveness in RelapsedRefractory Non-Hodgkins Lymphomas and Advanced Solid Tumors

What this Trial Is About

Researchers are conducting an open-label, multicenter, first-in-human phase III trial to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of HH2853 in patients with relapsed or refractory non-Hodgkins lymphomas and advanced solid tumors. The study has three parts phase I dose escalation, phase I dose extension, and phase II, with a focus on determining the maximum tolerated dose, recommended phase II dose, and assessing adverse events and treatment responses. HH2853 tablets are administered orally twice daily on a continuous 28-day cycle. In phase I dose escalation, doses will be increased to find the maximum tolerated dose and recommended phase II dose, using a special accelerated titration design. The dose extension phase will enroll additional patients to further evaluate safety, pharmacokinetics, and efficacy at selected doses. Phase II will enroll patients in three cohorts based on specific lymphoma types or solid tumors with particular genetic mutations. Participants will take HH2853 tablets on a fixed schedule and undergo regular assessments including safety monitoring, pharmacokinetic sampling, and evaluation of tumor response using standard criteria. Researchers will track adverse events, dose-limiting toxicities, objective response rates, and other clinical outcomes over 28-day treatment cycles. The study may last several treatment cycles with ongoing monitoring for safety and effectiveness, with an estimated study end date in late 2028.

Evaluate the Safety and Clinical Activity of HH2853