ICP-248 for B-cell Lymphoma

Recruiting at 7 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: InnoCare Pharma Inc.

Must be taking: Bruton's kinase inhibitors

Must not be taking: Strong CYP3A/CYP2C8 inhibitors

Disqualifiers: CNS involvement, Richter's transformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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

I can communicate well and follow the study's requirements.

My liver, kidneys, lungs, and heart are functioning well.

My blood counts are within normal ranges.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ICP-248 daily with dose escalation and expansion cohorts, with cycles comprising 28 days

28 weeks

Weekly visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Extension

Participants may continue treatment with ICP-248 in an open-label extension

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• ICP-248
• Obinutuzumab
• Rituximab

Trial Overview The study tests ICP-248 alone or combined with anti-CD20 antibodies Obinutuzumab or Rituximab in treating mature B-cell malignancies. It aims to assess the safety of these treatments and how well they work against these cancers.

How Is the Trial Designed?

Group I: Dose-Expansion Cohort C - MCL Experimental Treatment 2 Interventions

Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose and Rituximab for 18 cycles. Cycles will comprise 28 days.

Group II: Dose-Expansion Cohort B - MCL Experimental Treatment 1 Intervention

Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days.

Group III: Dose-Expansion Cohort A - CLL/SLL Experimental Treatment 2 Interventions

Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose and obinutuzumab for 6 cycles. Cycles will comprise 28 days.

Group IV: Dose-Escalation Cohort - CLL/SLL and MCL Experimental Treatment 1 Intervention

Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days.

Who Is Running the Clinical Trial?

InnoCare Pharma Inc.

Lead Sponsor

Trials

5

Recruited

610+