This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed or refractory non-hodgkin lymphoma.
Aged ≥ 18 years old.
Diagnosed as relapsed or refractory non-hodgkin lymphoma .
The patient must have measurable diseases.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
Known active central nervous system (CNS) involvement Lymphoma.
Excludes other active malignancies within 3 years before first dose, except locally curable cancers after radical treatment.
Uncontrolled or severe cardiovascular disorders.
Presence or history of clinically significant CNS diseases.
Single group
ICP-490
DrugSpecified dose on specified days
Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0
Incidence, type, and severity of dose-limiting toxicities (DLTs);
Recommended Phase 2 Doses（RP2Ds） and/or maximum tolerated doses（MTDs）.
ORR assessed according to the Lugano criteria (Cheson 2014).
PK parameters: maximum concentration (Cmax)
PK parameters: time to maximum concentration (Tmax)
PK parameters: half-life (T1/2)
PK parameters: area under the concentration-time curve (AUC0-∞ and AUC0-t)
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This trial is not recruiting at the moment. You can still explore other options:
