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The Study of ICP-248 in Patients With Mature B-cell Malignancies
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
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
Conditions
Interventions
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.
ICP-248
Eligible patients will receive ICP-248 orally as specified in the treatment arm.
ICP-248+Orelabrutinib
Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
ICP-248+Orelabrutinib
Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
ICP-248 +Rituximab
Eligible patients will receive ICP-248 and Rituximab as specified in the treatment arm.
ICP-248+Orelabrutinib
Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
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