A Study to Assess PK, Safety and Efficacy of HSK47977 Tab... | NCT07283796

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

NCT07283796

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Status

Recruiting

Last Update Posted

Dec 19, 2025Actual

Enrollment

110Estimated

Phase

Phase 1

Conditions

Interventions

HSK47977

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2025Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Dec 2, 2025

First Submission Date that Met QC Criteria

Dec 2, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2025

Last Update Posted Date

Dec 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
HSK47977	Drug	Taken orally once daily.	Phase Ia (Dose Escalation Part): HSK47977 Phase Ia (Extension Part): HSK47977 Phase Ib: HSK47977

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided