ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

November 18, 2025 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

226

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Yanli Yang
      • Hefei, Anhui, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Jian Ge
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)
        • Contact:
          • Xingbing Wang
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Hongmei Jing
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Xiaoqiong Tang
      • Chongqing, Chongqing Municipality, China, 400037
        • Recruiting
        • Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
        • Contact:
          • Xixi Xiang
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Zhenshu Xu
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Bing Xu
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Gansu Provincial People's Hospital
        • Contact:
          • Qike Zhang
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
          • Xutao Guo
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong General Hospital
        • Contact:
          • Wenyu Li
      • Guangzhou, Guangdong, China, 510055
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Yang Liang
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Jun Luo
    • Guizhou
      • Zunyi, Guizhou, China, 563003
        • Not yet recruiting
        • The Affiliated Hospital of Zunyi Medical University
        • Contact:
          • Mingqiang Ren
    • Hebei
      • Shijiazhuang, Hebei, China, 050010
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
          • Lihong Liu
      • Tangshan, Hebei, China, 063000
        • Recruiting
        • The Affiliated Hospital of North China University of Science and Technology
        • Contact:
          • Zhenyu 063000 Yan
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Ling Qin
      • Nanyang, Henan, China, 473005
        • Recruiting
        • Nanyang City Center Hospital
        • Contact:
          • Chao Li
      • Zhengzhou, Henan, China, 463599
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • zunmin Zhu
      • Zhenzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College, Huazhong University Of Science And Technology
        • Contact:
          • Guohui Cui
      • Wuhan, Hubei, China, 430011
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Xiaoxi Zhou
      • Yichang, Hubei, China, 443003
        • Recruiting
        • Yichang Central People's Hospital
        • Contact:
          • Huili Cai
    • Hunan
      • Changsha, Hunan, China, 410031
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Fang Zhou
      • Changsha, Hunan, China, 410012
        • Recruiting
        • The Second Xiangya Hospital, Central South University
        • Contact:
          • Hongling Peng
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Not yet recruiting
        • Changzhou First People's Hospital
        • Contact:
          • weiying gu
      • Huai'an, Jiangsu, China, 223300
        • Recruiting
        • Huai'an first people's hospital
        • Contact:
          • Chunling Wang
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Wei Xu
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Fei Li
    • Jilin
      • Changchun, Jilin, China, 130061
        • Recruiting
        • Bethune First Hospital Of Jilin University
        • Contact:
          • Ou Bai
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • Xiuhua Sun
      • Shenyang, Liaoning, China, Liaoning
        • Recruiting
        • Shengjing Hospital affiliated to China Medical University
        • Contact:
          • Aijun Liao
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Ming Hou
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Xiaosheng Fang
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Ji Ma
      • Jining, Shandong, China, 272011
        • Recruiting
        • Jining First People's Hospital
        • Contact:
          • Tongfeng Zhao
      • Linyi, Shandong, China, 276002
        • Recruiting
        • Linyi City Cancer Hospital
        • Contact:
          • Meifang Zheng
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital
        • Contact:
          • Yan Yuan
      • Shanghai, Shanghai Municipality, China, 201108
        • Not yet recruiting
        • Shanghai Huashan Hospital
        • Contact:
          • Yan Yuan
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • The Second Hospital of Shanxi Medical University
        • Contact:
          • Zhuanzhen Zheng
      • Taiyuan, Shanxi, China, 030013
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Liping Su
      • Xi’an, Shanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • yi wang
      • Xi’an, Shanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Jianli Wang
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Kai Shen
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • xiaobing huang
      • Yibin, Sichuan, China, 644002
        • Recruiting
        • Yibin Second People's Hospital
        • Contact:
          • shihua huang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Blood Diseases Hospital of Chinese Academy of Medical Sciences
        • Contact:
          • Tingyu Wang
      • Tianjin, Tianjin Municipality, China, 300120
        • Not yet recruiting
        • Tianjin People's Hospital
        • Contact:
          • xingli Zhao
      • Tianjin, Tianjin Municipality, China, 300181
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Lihua Qiu
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000
        • Recruiting
        • The Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
          • Shujuan Wen
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Mingxia Shi
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Wenjuan Yu
      • Ningbo, Zhejiang, China, 315040
        • Recruiting
        • The People's Hospital Affiliated to Ningbo University
        • Contact:
          • Ying Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 80 years.
  2. CLL/SLL is diagnosed by histopathology and/or flow cytometry according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018):
  3. Having an indication for treatment that meets the criteria for iwCLL 2018
  4. Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
  5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
  6. Adequate hematologic function
  7. Patients with basically normal coagulation function
  8. Patients with adequate hepatic, renal, pulmonary and cardiac functions
  9. Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
  10. Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF).

Exclusion Criteria:

  1. Central nervous system involvement.
  2. Concomitant Richter transformation.
  3. Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
  4. Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
  5. History of allogeneic stem cell transplantation.
  6. Major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial.
  7. Presence of active infection that requires intravenous anti-infective therapy.
  8. Hepatitis B or C virus infection.
  9. History of immunodeficiency disease or Significant cardiovascular disease
  10. Central nervous system disorders or Severe bleeding disorder
  11. Alcohol or drug dependence.
  12. Mental disorders or poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICP-248 in combination with Orelabrutinib
Drug: ICP-248
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
Drug: Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria
Time Frame: Up to 6 years
Up to 6 years
Changes from baseline in pulse.
Time Frame: Up to 6 years
Up to 6 years
Changes from baseline in blood pressure.
Time Frame: Up to 6 years
Up to 6 years
Changes from baseline in ECG QRS interval.
Time Frame: Up to 6 years
Up to 6 years
Changes from baseline in ECG QT interval.
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

November 25, 2030

Study Completion (Estimated)

July 25, 2031

Study Registration Dates

First Submitted

April 6, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-CL-01203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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