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RECRUITING
NCT05728658
PHASE1

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

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

191

Start Date

2023-03-09

Completion Date

2026-10-30

Last Updated

2025-09-08

Healthy Volunteers

No

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.

Locations (22)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Central Hospital of Wuhan

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Shenyang Hospital Of China Medical University

Shenyang, Liaoning, China

Shandong cancer hospital

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China