ICP-248 for B-cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ICP-248 for certain blood cancers, specifically mature B-cell malignancies like CLL/SLL (chronic lymphocytic leukemia/small lymphocytic lymphoma) and MCL (mantle cell lymphoma). The goal is to assess the safety and effectiveness of ICP-248, both alone and in combination with other cancer-fighting antibodies. Participants receive varying doses and combinations, including some with additional medications like obinutuzumab or rituximab. This trial may suit those with these specific cancers who have tried at least two other treatments and still experience issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking any strong CYP3A or CYP2C8 inhibitors or inducers (certain medications, supplements, or foods like grapefruit) before starting the study. If you're on these, you'll need to wait for a period equal to 5 times their half-life (the time it takes for half of the drug to leave your body) before beginning the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ICP-248 appears safe. Early studies indicate that patients with certain B-cell cancers, especially those unresponsive to other treatments, tolerate it well.
When combined with obinutuzumab, an antibody treatment, the safety results align with those from other antibody studies. Obinutuzumab, studied independently, is generally considered safe, supporting its use with ICP-248.
Similarly, combining ICP-248 with rituximab, another antibody treatment, shows a consistent safety pattern. Rituximab is widely used and known to be safe in many cases.
Overall, early data suggests that ICP-248, whether used alone or with these antibodies, is safe and tolerated by patients. However, since this is early data, monitoring for potential side effects remains important as more people use the treatment.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ICP-248 because it targets B-cell lymphoma in a potentially more effective way than current treatments. Most treatments for B-cell lymphoma, like chemotherapy and monoclonal antibodies such as Rituximab, work by broadly attacking cancer cells, which can lead to significant side effects. ICP-248, however, is being explored for its specific action on a particular pathway that might reduce these side effects while maintaining or enhancing effectiveness. Additionally, some treatment arms combine ICP-248 with monoclonal antibodies like obinutuzumab and Rituximab, potentially enhancing the immune system's ability to target cancer cells. This combination approach could offer improved outcomes for patients with types of lymphoma like CLL/SLL and MCL.
What evidence suggests that this trial's treatments could be effective for B-cell lymphoma?
Research has shown that ICP-248 holds promise for treating B-cell lymphomas. Early studies suggest it is generally safe and effective, particularly when other treatments have failed. ICP-248 blocks BCL2, a protein that helps cancer cells survive, leading to their death. In this trial, some participants will receive ICP-248 alone, while others will receive it with obinutuzumab, an antibody that targets cancer cells. Early results indicate that this combination enhances effectiveness. Another group will receive ICP-248 with Rituximab, another cancer-targeting antibody, which has resulted in a high rate of positive responses, with many patients experiencing complete cancer remission. These findings suggest that ICP-248, whether used alone or in combination, could effectively treat B-cell cancers.12467
Are You a Good Fit for This Trial?
This trial is for people with certain B-cell malignancies, like lymphoma. Participants must have relapsed disease, measurable disease (for mantle cell lymphoma), normal blood clotting, and good liver, kidney, lung, and heart function. They should be able to perform daily activities with ease (ECOG score ≤1) and live at least 6 more months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ICP-248 daily with dose escalation and expansion cohorts, with cycles comprising 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue treatment with ICP-248 in an open-label extension
What Are the Treatments Tested in This Trial?
Interventions
- ICP-248
- Obinutuzumab
- Rituximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
InnoCare Pharma Inc.
Lead Sponsor