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

PHASE1RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

April 23, 2024

Primary Completion Date

June 25, 2027

Study Completion Date

October 25, 2027

Conditions
Mature B-cell Malignancies
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.

Trial Locations (8)

1135

RECRUITING

Medical Center of Limited Liability Company Arensia Exploratory Medicine, Kyiv

2091

RECRUITING

Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC, Kyiv

11590

RECRUITING

Clinical Research Alliance, Westbury

18009

RECRUITING

CNE CCOHTPC of Cherkasy Regional Council, Cherkasy

33322

RECRUITING

BRCR Medical Center, Plantation

49102

RECRUITING

"CNECity Clin Hosp#4of Dnipro City Council", Dnipro

79057

RECRUITING

SI Institute of Blood Pathology and Transfusion Medicine of AMSU, Lviv

00935

RECRUITING

Pan American Center for Oncology Trials, San Juan

Sponsors
All Listed Sponsors
lead

InnoCare Pharma Inc.

INDUSTRY

NCT06351527 - 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 | Biotech Hunter | Biotech Hunter