A First-in-Human Study of HP-002 for Relapsed or Refracto... | NCT07658352

Studies
A First-in-Human Study of HP-002 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

NCT07658352

Sponsor

Shanghai Helioson Pharmaceutical Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

114Estimated

Phase

Phase 1Phase 2

Conditions

B-Cell Non-Hodgkin Lymphoma

Interventions

HP-002

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2026Estimated

Primary Completion Date

Jun 26, 2029Estimated

Completion Date

Jun 26, 2031Estimated

First Submitted Date

Jun 12, 2026

First Submission Date that Met QC Criteria

Jun 16, 2026

First Posted Date

Jun 22, 2026Actual

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

Jun 16, 2026

Last Update Posted Date

Jun 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

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 an open-label, first-in-human dose escalation and dose expansion Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HP-002 in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma This study consists of two phases: a dose-exploration phase and a dose-expansion phase.

The safety and tolerability of HP-002 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.

The efficacy of HP-002 will be evaluated in Phase 2 study.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
escalation part	Experimental	Drug: HP-002
expansion cohort 1	Experimental	Drug: HP-002
expansion cohort 2	Experimental	Drug: HP-002
expansion cohort 3	Experimental	Drug: HP-002
expansion cohort 4	Experimental	Drug: HP-002
expansion cohort 5	Experimental	Drug: HP-002

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HP-002	Drug	HP-002 will be taken once daily, at approximately the same time each morning.	escalation part expansion cohort 1 expansion cohort 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose-limiting toxicities (DLTs)		28 days after the first dose
Adverse events (AEs)		up to 5 years
Overall Response Rate (ORR)		up to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
Patients with relapsed or refractory B-cell non-Hodgkin lymphoma subtypes (CLL/SLL, MCL, MZL, DLBCL, FL, WM, and PCNSL).

Exclusion Criteria:

Prior use of a BTK protein degrader.

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yunju Yi	Contact	+86	+8613518115493	yiyunju@eastonpharma.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University Cancer Center		Guangzhou	Guangdong		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016393	Lymphoma, B-Cell

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided