This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
ICP-022 The drug product is a white, round, uncoated tablet
Part 1 Dose Escalation:The maximum tolerated dose (MTD)
To determine the maximum tolerated dose (MTD)
Time frame: Incidence of dose limiting toxicities (DLTs) up to 28 days
Part 2 Dose Expansion:ORR
To assess anti-tumor activity of Orelabrutinib (ICP-022) in Patients with B-cell malignancies including r/r MCL, r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
Time frame: Up to 2 years
Part 1 Dose Escalation:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
Time frame: Up to 2 years
Part 1 Dose Escalation:ORR
Objective response rate
Time frame: Up to 2 years
Part 1 Dose Escalation:T1/2
Elimination half-life
Time frame: Up to 2 years
Part 2 Dose Expansion:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
Time frame: Up to 2 years
Part 2 Dose Expansion:DOR
Duration of response
Time frame: Up to 2 years
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