Actively Recruiting
A Study to Assess PK, Safety and Efficacy 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
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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, with no gender restriction
- Confirmed diagnosis of relapsed or refractory Non-Hodgkin Lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 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 during the study and for at least 3 months after last dose, with voluntary use of effective contraception
You will not qualify if you...
- Presence of other severe or unstable diseases that make 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
- Any conditions increasing risk or interfering with results
- Any other situations deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
Y
Yunfen Li
CONTACT
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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