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

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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07658352

Enrollment

114

Registered

2026-06-22

Start date

2026-06-26

Completion date

2031-06-26

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Cell Non-Hodgkin Lymphoma

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.

Interventions

DRUGHP-002

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Countries

China

Contacts

CONTACTYunju Yi

yiyunju@eastonpharma.cn+86

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026