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RECRUITING
NCT06351527
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

ICP-248

ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).

DRUG

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.

DRUG

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