Trial Title:
The Study of ICP-248 in Patients With Mature B-cell Malignancies
NCT ID:
NCT05728658
Condition:
Hematological Malignancies
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICP-248
Description:
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.
Arm group label:
ICP-248
Summary:
This is a Phase I study to evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics, and preliminary efficacy of ICP-248 in patients with mature B-cell
malignancies. This study consists of two parts: Part 1 dose-finding period and Part 2
dose expansion period
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 and ≤ 80 years.
2. One of the following histopathologically and/or flow cytometry-confirmed diseases
according to the 2016 World Health Organization (WHO) classification criteria for
lymphohematopoietic neoplasms or meeting the International Workshop on Chronic
Lymphocytic Leukemia (iwCLL) criteria: Histopathologically and/or flow
cytometry-confirmed CLL/SLL; Pathologically confirmed MCL; Pathologically confirmed
B-NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL),
marginal zone lymphoma (MZL), and lymphoplasmacytic lymphoma (LPL).
3. Relapsed disease or refractory disease
4. For subjects with B-NHL: Patients must have measurable diseasePatients with an
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a
life expectancy of ≥ 6 months.
5. Adequate hematologic function.
6. Patients with basically normal coagulation function.
7. Patients with adequate hepatic, renal, pulmonary and cardiac functions.
8. CLL/SLL Patients with an absolute lymphocyte count ≥ 50 x 109/L and any lymph nodes
≥ 5 cm in the long diameter or CLL/SLL or B-NHL patients with any lymph nodes ≥ 10
cm in the long diameter will be enrolled in the study after weighing the risks and
benefits with the sponsor's MM.
9. Female patients of childbearing potential must have a negative blood pregnancy test
within 7 days prior to the first dose of the investigational product; patients of
childbearing potential (males and females) must agree to use a reliable birth
control method (hormonal or barrier method or abstinence) with their partners from
signing the ICF until 90 days after the last dose.
10. Subjects are able to communicate with the investigator well and to complete the
study as specified in the study.
11. 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).
12. Subjects with CLL/SLL must have an indication for treatment as judged by the
investigator.
Exclusion Criteria:
1. Prior malignancy (other than the disease under study) within 2 years before study
entryKnown
2. Central nervous system involvement by lymphoma/leukemia
3. Underlying medical conditions that, in the investigator's opinion, will render the
administration of the investigational product hazardous or obscure the
interpretation of the safety or efficacy results.
4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant); or prior
chimeric cell therapy (unless ≥ 3 months after cell infusion).
5. Received a BCL-2 inhibitor prior to initial use of the investigational drug and did
not achieve disease remission or disease recurrence/progression on treatment;
Disease recurrence/progression after stopping or ending BCL-2 inhibitor therapy is
acceptable.
6. A history of allogeneic stem cell transplantation.
7. Anti-cancer therapy within 14 days prior to the first dose of the investigational
product
8. An interval of less than 5 half-lives from the last dose of a strong CYP3A or CYP2C8
inhibitor or inducer (chemical agent, traditional Chinese medicine and dietary
supplement) to the first dose of the investigational product, or a plan to use
concurrently medications, dietary supplements or food (e.g., grapefruit or
grapefruit juice) with strong CYP3A or CYP2C8 inhibitory or inductive effect during
study participation.
9. Patients who have undergone major organ surgery (excluding aspiration biopsy) or
significant trauma within 28 days prior to the first dose of the investigational
product, or who require elective surgery during the trial.
10. Patients who have received a live attenuated vaccine within 28 days prior to the
first dose of the investigational product (except for vaccination to prevent a major
public health event).
11. Presence of active infection that currently requires intravenous systemic
anti-infective therapy.
12. Patients with active hepatitis B or C virus infection.
13. History of immunodeficiency, including a positive human immunodeficiency virus (HIV)
antibody test.
14. History of significant cardiovascular disease
15. Patients with previous or concomitant central nervous system disordersHistory or
current evidence of severe interstitial lung disease.
16. ≥ Grade 2 toxicity due to prior anti-cancer therapy at enrollment (except for
alopecia, ANC, hemoglobin and PLT). For ANC, hemoglobin and PLT, please follow the
inclusion criteria.
17. History of severe bleeding disorder
18. Known alcohol or drug dependence.
19. Presence of mental disorders or poor compliance.
20. Female patients who are pregnant or lactating.
21. Unable to swallow tablets or disease significantly affecting gastrointestinal
function.
22. Hypersensitivity to the active substance or excipients of ICP-248 tablets.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233099
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanli Yang
Facility:
Name:
The First Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230022
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Ge
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Jing
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Wang
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Shaoyuan Wang
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Xu
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510062
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiming Li
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Keshu Zhou
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongxing Jiang
Facility:
Name:
The Central Hospital of Wuhan
Address:
City:
Wuhan
Zip:
430014
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongxiang Wang
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Guohui Cui
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yajun Li
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Huayuan Zhu
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wuping Li
Facility:
Name:
The Second Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116027
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiuhua Sun
Facility:
Name:
Shenyang Hospital Of China Medical University
Address:
City:
Shenyang
Zip:
110022
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Yang
Facility:
Name:
Shandong cancer hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Zengjun Li
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianqing Mi
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Liqun Zou
Facility:
Name:
Hematology Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuhua Yi
Phone:
15900265415
Email:
yishuhua@ihcams.ac.cn
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Jin
Start date:
March 9, 2023
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
Beijing InnoCare Pharma Tech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05728658
