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NCT Number: NCT07283796

A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

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.

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Key information

Conditions

NHL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese Academy of Medical Sciences Blood Diseases Hospital

Tianjin, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HSK47977

Drug

Taken orally once daily.

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: Within first 28 days of treatment

    Highest dose level at which under 33% of patients in a cohort experience DLT(dose limiting toxicity)

Study contacts

Contact information is provided by the study sponsor or research team.

Yunfen Li

CONTACT

[email protected]

(+86)18108214952

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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