A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Patients With Mature B-cell Malignancies
Summary
Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 as monotherapy or in combination with anti-CD20 monoclonal antibody in Mature B-cell Malignancies
Arms & interventions
- DrugICP-248
ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).
- DrugObinutuzumab (G)
Obinutuzumab will be administered by IV infusion at a dose of 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6.
- DrugRituximab (R)
Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m\^2) at Day 1 per week for 4 weeks during cycle 1, then on day 1 of cycles 3-8, and thereafter once every other cycle up to 2 years.
Outcome measures
Primary
DLT
Dose-limiting toxicity (DLT) rate at each dose level DLT will be assessed via CTCAE version 5.0 or iwCLL 2018.
Time frame: 49 days
Safety and tolerability of ICP-248 at different doses in B-cell malignancies
To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria or iwCLL 2018.
Time frame: 5 years
Secondary
Cmax, ss of ICP-248
Time frame: Predose up to week 28
Ctrough, ss of ICP-248
Time frame: Predose up to week 28
Preliminary efficacy of ICP-248 monotherapy in patients with B-cell malignancy
Time frame: 5 years
Eligibility criteria
Study locations (2)
BRCR Medical Center
Plantation, Florida, 33322
Clinical Research Alliance
Westbury, New York, 11590