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Hematologic MalignanciesPhase 2/3NCT06378138

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

A Phase 2/3 study testing ICP-248 and Orelabrutinib in people with Hematologic Malignancies, run by Beijing InnoCare Pharma Tech Co., Ltd. at 53 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hematologic Malignancies
What is being tested?
ICP-248 and Orelabrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
53 sitesChina
Study dates
15 May 2024to 25 Jul 2031
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤ 80 years.
  • 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):
  • Having an indication for treatment that meets the criteria for iwCLL 2018
  • Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
  • Adequate hematologic function
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  • Patients with basically normal coagulation function
  • Patients with adequate hepatic, renal, pulmonary and cardiac functions
  • Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
  • 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).

Who cannot join

  • Central nervous system involvement.
  • Concomitant Richter transformation.
  • Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
  • Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
  • History of allogeneic stem cell transplantation.
  • 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.
Show all 12Show fewer
  • Presence of active infection that requires intravenous anti-infective therapy.
  • Hepatitis B or C virus infection.
  • History of immunodeficiency disease or Significant cardiovascular disease
  • Central nervous system disorders or Severe bleeding disorder
  • Alcohol or drug dependence.
  • Mental disorders or poor compliance.

Trial locations and contacts

53 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alexia Lu contact

010-66609745

CO_HGRAC@innocarepharma.com

53 sites in 1 country

China53 sites, 53 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Hongmei Jing

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

    Yanli Yang

    Recruiting

  • Bethune First Hospital of Jilin University

    Changchun, Jilin, 130061

    Ou Bai

    Recruiting

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410012

    Hongling Peng

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Fang Zhou

    Recruiting

  • Changzhou First People's Hospital

    Changzhou, Jiangsu, 213003

    Weiying Gu

    Not yet recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Kai Shen

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Xiaobing Huang

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Xiaoqiong Tang

    Recruiting

  • Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University

    Chongqing, Chongqing Municipality, 400037

    Xixi Xiang

    Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

    Xiuhua Sun

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Zhenshu Xu

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510055

    Yang Liang

    Recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

    Wenyu Li

    Not yet recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

    Xutao Guo

    Not yet recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Wenjuan Yu

    Recruiting

  • Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)

    Hefei, Anhui, 230001

    Xingbing Wang

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Jian Ge

    Recruiting

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300

    Chunling Wang

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Ming Hou

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

    Xiaosheng Fang

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Ji Ma

    Recruiting

  • Jining First People's Hospital

    Jining, Shandong, 272011

    Tongfeng Zhao

    Recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

    Mingxia Shi

    Recruiting

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu, 730000

    Qike Zhang

    Recruiting

  • Linyi City Cancer Hospital

    Linyi, Shandong, 276002

    Meifang Zheng

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

    Ling Qin

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Fei Li

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Wei Xu

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Jun Luo

    Not yet recruiting

  • Nanyang City Center Hospital

    Nanyang, Henan, 473005

    Chao Li

    Recruiting

  • The People's Hospital Affiliated to Ningbo University

    Ningbo, Zhejiang, 315040

    Ying Lu

    Recruiting

  • Huashan Hospital

    Shanghai, Shanghai Municipality, 200040

    Yan Yuan

    Recruiting

  • Shanghai Huashan Hospital

    Shanghai, Shanghai Municipality, 201108

    Yan Yuan

    Not yet recruiting

  • Shengjing Hospital affiliated to China Medical University

    Shenyang, Liaoning, Liaoning

    Aijun Liao

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050010

    Lihong Liu

    Recruiting

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Zhuanzhen Zheng

    Not yet recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

    Liping Su

    Not yet recruiting

  • The Affiliated Hospital of North China University of Science and Technology

    Tangshan, Hebei, 063000

    Zhenyu 063000 Yan

    Recruiting

  • Blood Diseases Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

    Tingyu Wang

    Recruiting

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300120

    Xingli Zhao

    Not yet recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300181

    Lihua Qiu

    Recruiting

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region, 830000

    Shujuan Wen

    Recruiting

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

    Wuhan, Hubei, 430011

    Xiaoxi Zhou

    Recruiting

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

    Wuhan, Hubei, 430022

    Guohui Cui

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

    Jianli Wang

    Recruiting

  • Shaanxi Provincial People's Hospital

    Xi’an, Shanxi, 710068

    Yi Wang

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Bing Xu

    Recruiting

  • Yibin Second People's Hospital

    Yibin, Sichuan, 644002

    Shihua Huang

    Recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

    Huili Cai

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 463599

    Zunmin Zhu

    Recruiting

  • Henan Cancer Hospital

    Zhenzhou, Henan, 450003

    Keshu Zhou

    Recruiting

  • The Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563003

    Mingqiang Ren

    Not yet recruiting

Other trials in China

About this study

Official title: 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

Being tested
ICP-248, Orelabrutinib
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-248Drug

    Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle

  • OrelabrutinibDrug

    Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle

Study groups in NCT06378138
Study groupRoleWhat they receive
ICP-248 in combination with OrelabrutinibExperimentalNot described
Receives: Drug: ICP-248; Drug: Orelabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria

    Measured: Up to 6 years

  2. Changes from baseline in pulse.

    Measured: Up to 6 years

  3. Changes from baseline in blood pressure.

    Measured: Up to 6 years

  4. Changes from baseline in ECG QRS interval.

    Measured: Up to 6 years

  5. Changes from baseline in ECG QT interval.

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start15 May 2024
  3. Primary completion25 Nov 2030 (estimated)
  4. Study completion25 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06378138
Sponsor's protocol ID
ICP-CL-01203
Status last verified
Oct 2025
First submitted
6 Apr 2024
Last updated
21 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ICP-248 and Orelabrutinib in people with Hematologic Malignancies, run by Beijing InnoCare Pharma Tech Co., Ltd. at 53 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria (time frame: Up to 6 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06378138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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