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A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT07283796 · Haisco Pharmaceutical Group Co., Ltd.
In plain English
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Official title
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
About this study
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. 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.
Study design
Enrollment target: 110 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-28
Estimated completion: 2027-12
Last updated: 2025-12-19
Interventions
Drug: HSK47977
Primary outcomes
- • Maximum tolerated dose (MTD) (Within first 28 days of treatment)
Sponsor
Haisco Pharmaceutical Group Co., Ltd. · industry
Contacts & investigators
ContactYunfen Li · contact · liyunfen@haisco.com · (+86)18108214952
All locations (1)
Chinese Academy of Medical Sciences Blood Diseases HospitalRecruiting
Tianjin, China