drugset / Trial / NCT05728658

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

NCT05728658

Phase 1 Recruiting 191 enrolled Beijing InnoCare Pharma Tech Co., Ltd.
Non-randomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start
2023-03-09
Primary completion
2025-08-30
Completion
2026-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ICP-248 Unknown Oral
Subject Orelabrutinib Small molecule 150 mg
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous