Phase I Study of HSK47977 Tablets to Test Safety, Effectiveness, and Drug Behavior in Adults with Relapsed or Refractory Non-Hodgkins Lymphoma

What this Trial Is About

Researchers are evaluating HSK47977 tablets in adults with relapsed or refractory Non-Hodgkins Lymphoma NHL to understand its safety, effectiveness, and how the body processes the drug. This Phase I clinical trial includes two parts a dose-escalation stage and a dose-expansion stage, aiming to find the best dose and assess treatment effects. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd. and is expected to last about two years. Participants will receive HSK47977 tablets orally once daily. The trial has three phases Phase 1a dose escalation to test various dose levels, Phase 1a extension to continue dosing at selected levels, and Phase 1b dose expansion at the recommended dose for Phase II studies. Each part helps researchers understand how different doses affect safety and treatment response. During the study, participants will be monitored for safety and how well they tolerate the treatment, especially within the first 28 days to determine the maximum tolerated dose. They will undergo evaluations including clinical assessments and biopsies. Researchers will track organ function, survival expectancy, and measurable lesions to understand treatment impact. Participants must comply with contraceptive requirements and be followed closely throughout the trial period.

A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma