A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK47977.
- Who it may be relevant to
- Registry conditions: NHL. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug HSK47977
Taken orally once daily.
Primary outcome measures
- Maximum tolerated dose (MTD) [Time frame: Within first 28 days of treatment]
Eligibility criteria
Inclusion criteria
- Voluntarily sign the informed consent form.
- Age ≥18 years, with no gender restriction.
- Pathologically confirmed patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Expected survival >3 months.
- Presence of measurable lesions.
- Adequate organ function.
- Agreement to undergo pathological tissue biopsy.
- Subjects of childbearing potential must agree to comply with the contraceptive requirements of the study.
- 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
- Concurrent presence of other severe, unstable diseases/conditions that, in the investigator's judgment, make participation in this study unsuitable.
- History of or current severe cardiovascular disease.
- Poorly controlled blood pressure during the screening period.
- Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety.
- Electrocardiogram abnormalities determined by the investigator as potentially posing a risk to the subject's safety.
- History of allergies to the investigational drug or its excipients.
- Inability to discontinue prohibited medications as specified in the protocol during the screening period and throughout the entire study duration.
- Any other conditions that may increase subject risk or interfere with the trial results.
- Any other situations where the investigator deems the subject unsuitable for participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Sciences Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT07283796 · HSK47977-101