BridgeMD
Tests treatment safety and results for Mature B-cell Malignancies
Official title Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Mature B-cell Malignancies
ClinicalTrials.gov ID: NCT06351527
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 mature b-cell 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
- Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 as monotherapy or in combination with anti-CD20 monoclonal antibody in Mature B-cell Malignancies
- 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 and older
You may be able to join if
- Age ≥ 18.
- people with histopathologically and/or flow cytometry-confirmed diseases according to the 2016 World Health Organization (WHO) classification...
- For people with R/R MCL: Patients must have measurable disease per the Lugano 2014 criteria.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 1 and a life expectancy of ≥ 6 months.
- Adequate hematologic, hepatic, renal, pulmonary and cardiac function
You likely can't join if
- Known central nervous system involvement by lymphoma/leukemia.
- Known or suspected history of Richter's transformation.
- Prior autologous stem cell transplant (unless ≥ 3 months since transplant); or prior chimeric cell therapy (unless ≥ 3 months since cell infusion).
- A history of allogeneic stem cell transplantation.
- An interval of less than 5 half-lives from the last dose of a strong CYP3A or CYP2C8 inhibitor or inducer (chemical agent, herbal medicine and...
- Presence of active infection that currently requires intravenous systemic anti-infective therapy.
See the full eligibility criteria
- Age ≥ 18.
- people with histopathologically and/or flow cytometry-confirmed diseases according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the International...
- For people with R/R MCL: Patients must have measurable disease per the Lugano 2014 criteria.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 1 and a life expectancy of ≥ 6 months.
- Adequate hematologic, hepatic, renal, pulmonary and cardiac function
- Patients with basically normal coagulation function
- Patients with fertility potential and their partners need contraception
- people can communicate with the investigator well and to complete the study as specified in the study.
- Known central nervous system involvement by lymphoma/leukemia.
- Known or suspected history of Richter's transformation.
- Prior autologous stem cell transplant (unless ≥ 3 months since transplant); or prior chimeric cell therapy (unless ≥ 3 months since cell infusion).
- A history of allogeneic stem cell transplantation.
- An interval of less than 5 half-lives from the last dose of a strong CYP3A or CYP2C8 inhibitor or inducer (chemical agent, herbal medicine and dietary supplement) to the first dose of the investigational product, or a...
- Presence of active infection that currently requires intravenous systemic anti-infective therapy.
- 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 disorders
- Grade 2 or above toxicity due to prior anti-cancer therapy at screening
- Known alcohol or drug dependence
- Unable to swallow tablets or presence of disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic...
The study team makes the final eligibility decision.
Where it's taking place
- Plantation, Florida, United States
- Westbury, New York, United States
- San Juan, Puerto Rico
- Cherkasy, Ukraine
- Dnipro, Ukraine
- Kyiv, Ukraine
- Lviv, Ukraine
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Plantation, Florida, United States; Westbury, New York, United States; San Juan, Puerto Rico; Cherkasy, Ukraine; Dnipro, Ukraine; Kyiv, Ukraine and 1 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.