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
Bengbu, Anhui 233099, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230022, China
Peking University Third Hospital
Beijing, Beijing 100191, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing 400016, China
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001, China
Henan Cancer Hospital
Zhengzhou, Henan 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450008, China
The Central Hospital of Wuhan
Wuhan, Hubei 430014, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430022, China
Jiangsu Province Hospital
Nanjing, Jiangsu 210029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330000, China
Shenyang Hospital Of China Medical University
Shenyang, Liaoning 110022, China
Shandong cancer hospital
Jinan, Shandong 250117, China
West China Hospital of Sichuan University
Chengdu, Sichuan 610000, China
Hematology Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin 310000, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Age ≥ 18 and ≤ 80 years.
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).
Relapsed disease or refractory disease
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.
Adequate hematologic function.
Patients with basically normal coagulation function.
Patients with adequate hepatic, renal, pulmonary and cardiac functions.
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.
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.
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).
Subjects with CLL/SLL must have an indication for treatment as judged by the investigator.
Prior malignancy (other than the disease under study) within 2 years before study entryKnown
Central nervous system involvement by lymphoma/leukemia
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.
Prior autologous stem cell transplant (unless ≥ 3 months after transplant); or prior chimeric cell therapy (unless ≥ 3 months after cell infusion).
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.
A history of allogeneic stem cell transplantation.
Anti-cancer therapy within 28 days prior to the first dose of the investigational product
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.
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.
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).
Presence of active infection that currently requires intravenous systemic anti-infective therapy.
Patients with active hepatitis B or C virus infection.
History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
History of significant cardiovascular disease
Patients with previous or concomitant central nervous system disordersHistory or current evidence of severe interstitial lung disease.
≥ 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.
History of severe bleeding disorder
Known alcohol or drug dependence.
Presence of mental disorders or poor compliance.
Female patients who are pregnant or lactating.
Unable to swallow tablets or disease significantly affecting gastrointestinal function.
Hypersensitivity to the active substance or excipients of ICP-248 tablets.
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