Actively Recruiting
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
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2025-12-19
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HSK47977 tablets in adults with relapsed or refractory Non-Hodgkin's 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.
CONDITIONS
Brief Title
A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form.
- Age 18 years or older.
- Pathologically confirmed relapsed or refractory Non-Hodgkin Lymphoma.
- ECOG performance status score between 0 and 2.
- Expected survival longer than 3 months.
- Presence of measurable lesions.
- Adequate organ function.
- Agreement to undergo pathological tissue biopsy.
- Agreement to comply with contraceptive requirements if of childbearing potential.
- No pregnancy plans from screening until at least 3 months after last dose, with voluntary use of effective contraception.
You will not qualify if you...
- Presence of severe, unstable diseases or conditions making study participation unsuitable.
- History or current severe cardiovascular disease.
- Poorly controlled blood pressure during screening.
- Laboratory abnormalities posing safety risks.
- Electrocardiogram abnormalities posing safety risks.
- History of allergies to the study drug or its ingredients.
- Inability to stop prohibited medications during screening and study.
- Conditions increasing risk or interfering with study results.
- Any other situations deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Treatment cycles of 28 days; duration depends on dose escalation and extension phases until maximum tolerated dose or discontinuation.
Participants take HSK47977 tablets orally once daily as part of the treatment for relapsed or refractory Non-Hodgkin Lymphoma.
Visits occur periodically during treatment for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
Y
Yunfen Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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