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

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 Phase 1 study will test whether oral HSK47977 tablets are safe, how the body handles them, and whether they help adults with relapsed or refractory non-Hodgkin's lymphoma.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (industry)
• Locations: 1 site (Tianjin)
• Trial ID: NCT07283796 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18 years or older with pathologically confirmed relapsed or refractory non-Hodgkin's lymphoma, measurable lesions, ECOG 0–2, adequate organ function, and willingness to undergo biopsy and follow contraception rules are the intended participants.

Not a fit: Patients with severe unstable comorbidities, significant cardiovascular disease, poorly controlled blood pressure, or those who are pregnant or planning pregnancy are excluded and unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, HSK47977 could provide a new oral treatment option that improves disease control for patients with relapsed or refractory non-Hodgkin's lymphoma.

How similar studies have performed: Other early-phase programs of novel oral agents in relapsed/refractory NHL have sometimes shown clinical activity, but HSK47977 appears to be a novel compound with limited prior human data.

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.

Where this trial is running

Tianjin

• Chinese Academy of Medical Sciences Blood Diseases Hospital — Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Yunfen Li

Conditions: NHL