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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
HP-002 will be taken once daily, at approximately the same time each morning.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Dose-limiting toxicities (DLTs)
Time frame: 28 days after the first dose
Adverse events (AEs)
Time frame: up to 5 years
Overall Response Rate (ORR)
Time frame: up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.