About this trial
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
This trial does not accept healthy volunteersQualifiers
Voluntarily sign the informed consent form.
Age ≥18 years, with no gender restriction.
Pathologically confirmed patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL).
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
Disqualifiers
Concurrent presence of other severe, unstable diseases/conditions that, in the investigator's judgment, make participation in this study unsuitable.
History of or current severe cardiovascular disease.
Poorly controlled blood pressure during the screening period.
Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety.
Trial design
Single group
Treatments tested in this trial
HSK47977
DrugTaken orally once daily.
Treatment groups
Trial outcomes
Primary outcomes
Maximum tolerated dose (MTD)
Highest dose level at which under 33% of patients in a cohort experience DLT(dose limiting toxicity)
Sponsors and contacts
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