NCT07658352

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for phase_1

Timeline
60mo left

Started Jun 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jun 2031

First Submitted

Initial submission to the registry

June 12, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 26, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2031

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 12, 2026

Last Update Submit

June 16, 2026

Conditions

B-Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (6)

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

HP-002DRUG

HP-002 will be taken once daily, at approximately the same time each morning.

escalation partexpansion cohort 1expansion cohort 2expansion cohort 3expansion cohort 4expansion cohort 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Prior use of a BTK protein degrader.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Yunju Yi

CONTACT

+86yiyunju@eastonpharma.cn

Study Design

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

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 22, 2026

Study Start

June 26, 2026

Primary Completion (Estimated)

June 26, 2029

Study Completion (Estimated)

June 26, 2031

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)