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

NCT07283796 | Recruiting Phase 1

• 1 other identifier: HSK47977-101
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NHL

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Phase Ia (Dose Escalation Part): HSK47977

EXPERIMENTAL

Phase 1a (Dose Escalation Part): dose escalation of HSK47977 at various dose levels

Drug: HSK47977

Phase Ia (Extension Part): HSK47977

EXPERIMENTAL

Phase 1a (Part B): dose extention of HSK47977 at certain dose levels

Drug: HSK47977

Phase Ib: HSK47977

EXPERIMENTAL

Phase 1b: dose expansion for HSK47977 at dose of RP2D（Recommended Phase II Dose）

Drug: HSK47977

Interventions

HSK47977 DRUG

Taken orally once daily.

Phase Ia (Dose Escalation Part): HSK47977; Phase Ia (Extension Part): HSK47977; Phase Ib: HSK47977

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences Blood Diseases Hospital

Tianjin, China

RECRUITING

Central Study Contacts

Yunfen Li

CONTACT

（+86）18108214952; liyunfen@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)