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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
Sponsor: InnoCare Pharma Inc.
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2024-04-23
Completion Date
2027-10-25
Last Updated
2025-06-19
Healthy Volunteers
No
Conditions
Interventions
ICP-248
ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).
Obinutuzumab (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.
Rituximab (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.
Locations (8)
BRCR Medical Center
Plantation, Florida, United States
Clinical Research Alliance
Westbury, New York, United States
Pan American Center for Oncology Trials
San Juan, Puerto Rico
CNE CCOHTPC of Cherkasy Regional Council
Cherkasy, Ukraine
CNE"City Clin Hosp#4"of Dnipro City Council
Dnipro, Ukraine
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv, Ukraine
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kyiv, Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Lviv, Ukraine