NHL
Conditions
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.
Interventions
DRUGHSK47977
Taken orally once daily.
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety. 5. Electrocardiogram abnormalities determined by the investigator as potentially posing a risk to the subject's safety. 6. History of allergies to the investigational drug or its excipients. 7. Inability to discontinue prohibited medications as specified in the protocol during the screening period and throughout the entire study duration. 8. Any other conditions that may increase subject risk or interfere with the trial results. 9. Any other situations where the investigator deems the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) | Within first 28 days of treatment | Highest dose level at which under 33% of patients in a cohort experience DLT（dose limiting toxicity） |
Countries
China
Contacts
Primary ContactYunfen Li
Outcome results
None listed