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New treatment option for Hematological Malignancies
Official title The Study of ICP-248 in Patients With Mature B-cell Malignancies
ClinicalTrials.gov ID: NCT05728658
What this study is testing
What is ICP-248?
ICP-248 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hematological malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥ 18 and ≤ 80 years.
- One of the following histopathologically and/or flow cytometry-confirmed diseases according to the 2016 World Health Organization (WHO)...
- Relapsed disease or refractory disease
- For people with B-NHL: Patients must have measurable diseasePatients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score...
- Adequate hematologic function.
You likely can't join if
- 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...
- 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...
- A history of allogeneic stem cell transplantation.
See the full eligibility criteria
- 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...
- Relapsed disease or refractory disease
- For people 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...
- 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...
- people are able to communicate with the investigator well and to complete the study as specified in the study.
- Before the trial, the people 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...
- people 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 how well it works 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...
- A history of allogeneic stem cell transplantation.
- Anti-cancer therapy within 14 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 inhibitor or inducer (chemical agent, traditional Chinese medicine and dietary supplement) to the first dose of the investigational product, or...
- 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 or Orelabrutinib tablets (only applicable to people in cohort G/H/J/K).Severe allergic reaction or intolerance to murine monoclonal antibodies or...
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.