A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Trial Parameters
Brief Summary
This is a Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma.This study includes a Phase Ia dose-escalation stage and a Phase Ib dose-expansion stage, and it is expected to take approximately 2 years.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form. 2. Age ≥18 years, with no gender restriction. 3. Pathologically confirmed patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL). 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 5. Expected survival \>3 months. 6. Presence of measurable lesions. 7. Adequate organ function. 8. Agreement to undergo pathological tissue biopsy. 9. Subjects of childbearing potential must agree to comply with the contraceptive requirements of the study. 10. No pregnancy plans from screening until at least 3 months after the last dose of the study drug, and voluntary use of effective contraceptive measures. Exclusion Criteria: 1. Concurrent presence of other severe, unstable diseases/conditions that, in the investigator's judgment, make participation in this study unsuitable. 2. History of or current severe cardiovascular disease. 3. Poorly controlled blood pressure during the screening period. 4. Labor