NCT05728658

The Study of ICP-248 in Patients With Mature B-cell Malignancies

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination Therapy in Patients With Mature B-cell Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 191 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination Therapy in Patients with Mature B-cell Malignancies.This study consists of two parts: Part 1 dose-finding period and Part 2 dose expansion period.

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
DRUG	ICP-248	Eligible patients will receive ICP-248 orally as per the protocol, once daily for every 28 days as one treatment cycle (except for the food effect investigation phase), until progressive disease (PD), intolerable toxicity, withdrawal of consent, loss to follow-up, initiation of other anti-cancer therapy, death, or end of study, whichever occurs first.
DRUG	ICP-248	Eligible patients will receive ICP-248 orally as specified in the treatment arm.
DRUG	ICP-248+Orelabrutinib	Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
DRUG	ICP-248+Orelabrutinib	Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
DRUG	ICP-248 +Rituximab	Eligible patients will receive ICP-248 and Rituximab as specified in the treatment arm.
DRUG	ICP-248+Orelabrutinib	Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
DRUG	ICP-248+Orelabrutinib+Rituximab	Eligible patients will receive ICP-248 and Orelabrutinib and Rituximab as specified in the treatment arm.

Timeline

• Start date: 2023-03-09
• Primary completion: 2025-08-30
• Completion: 2026-10-30
• First posted: 2023-02-15
• Last updated: 2025-09-08

Locations

22 sites across 1 country: China