HSK47977 tablets for adults with relapsed or refractory non-Hodgkin's lymphoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase Ia dose-escalation followed by a Phase Ib dose-expansion trial of oral HSK47977 in adults with relapsed or refractory non-Hodgkin's lymphoma. The study will collect safety data, pharmacokinetic and pharmacodynamic profiles, and preliminary measures of anti-lymphoma activity. Eligible participants must have measurable disease, adequate organ function, and agree to tissue biopsy and contraceptive requirements. The overall planned duration is approximately two years and enrollment is at a single center in Tianjin, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese Academy of Medical Sciences Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Yunfen Li
• Email: liyunfen@haisco.com
• Phone: （+86）18108214952

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.