Orelabrutinib for B-Cell Malignancies
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
Are You a Good Fit for This Trial?
This trial is for adults over 18 with certain B-cell malignancies, like relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Participants need to have a life expectancy of at least 4 months, be in good physical condition, and not have active hepatitis or HIV. Pregnant women and those who've had recent major surgeries or other cancer treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Part 1 involves dose escalation to determine the maximum tolerated dose (MTD) of Orelabrutinib
Dose Expansion
Part 2 involves dose expansion to assess anti-tumor activity in patients with B-cell malignancies
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Orelabrutinib (ICP-022)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beijing InnoCare Pharma Tech Co., Ltd.
Lead Sponsor