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NOT YET RECRUITING
NCT07658352
PHASE1/PHASE2

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

Sponsor: Shanghai Helioson Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2026-06-26

Completion Date

2031-06-26

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

DRUG

HP-002

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China