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

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.

Study Overview

• Status: Recruiting
• Conditions: NHL
• Intervention / Treatment: Drug: HSK47977

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yunfen Li; Phone Number: （+86）18108214952; Email: liyunfen@haisco.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase Ia (Dose Escalation Part): HSK47977; Phase 1a (Dose Escalation Part): dose escalation of HSK47977 at various dose levels	Drug: HSK47977; Taken orally once daily.
Experimental: Phase Ia (Extension Part): HSK47977; Phase 1a (Part B): dose extention of HSK47977 at certain dose levels	Drug: HSK47977; Taken orally once daily.
Experimental: Phase Ib: HSK47977; Phase 1b: dose expansion for HSK47977 at dose of RP2D（Recommended Phase II Dose）	Drug: HSK47977; Taken orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose (MTD)	Highest dose level at which under 33% of patients in a cohort experience DLT（dose limiting toxicity）	Within first 28 days of treatment

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HSK47977-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No