RecruitingPhase 1NCT07283796

A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects 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


Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

110 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug called HSK47977 is safe and effective for patients with relapsed or refractory non-Hodgkin's lymphoma — a cancer of the lymphatic system that has come back or stopped responding to previous treatment. **You may be eligible if...** - You are 18 or older - You have been confirmed by biopsy to have relapsed or refractory non-Hodgkin's lymphoma - Your general health is rated 0–2 on the ECOG scale (able to carry out most daily activities) - You are expected to survive at least 3 months - You have at least one measurable tumor on imaging - You are willing to provide a biopsy sample - You agree to use effective contraception during the study and 3 months afterward **You may NOT be eligible if...** - You have another serious uncontrolled medical condition - Your organ function does not meet the study's requirements - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHSK47977

Taken orally once daily.


Locations(1)

Chinese Academy of Medical Sciences Blood Diseases Hospital

Tianjin, China

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NCT07283796


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