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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: InnoCare Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Mature B-cell Malignancies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-23
• Primary completion: 2027-06-25
• Completion: 2027-10-25
• First posted: 2024-04-08
• Last updated: 2025-06-19

Locations

8 sites across 3 countries: United States, Puerto Rico, Ukraine

Regulatory

• FDA-regulated drug study