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

NCT05728658 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2025-09-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05728658 on ClinicalTrials.gov