A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT ID: NCT07283796
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
110 participants
INTERVENTIONAL
2025-08-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase Ia (Dose Escalation Part): HSK47977
Phase 1a (Dose Escalation Part): dose escalation of HSK47977 at various dose levels
HSK47977
Taken orally once daily.
Phase Ia (Extension Part): HSK47977
Phase 1a (Part B): dose extention of HSK47977 at certain dose levels
HSK47977
Taken orally once daily.
Phase Ib: HSK47977
Phase 1b: dose expansion for HSK47977 at dose of RP2D（Recommended Phase II Dose）
HSK47977
Taken orally once daily.
Interventions
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HSK47977
Taken orally once daily.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chinese Academy of Medical Sciences Blood Diseases Hospital
Tianjin, , China
Countries
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Central Contacts
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Other Identifiers
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HSK47977-101
Identifier Type: -
Identifier Source: org_study_id