Orelabrutinib for B-Cell Malignancies

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

No Placebo Group

Trial Summary

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).

Research Team

Eligibility Criteria

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

I am 18 years old or older.

Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection)

Life expectancy (in the opinion of the investigator) of ≥ 4 months

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Exclusion Criteria

I am currently taking warfarin, vitamin K antagonists, or strong CYP3A inhibitors.

Pregnant or breast-feeding or intending to become pregnant during the study

I finished IV treatment for an infection less than 14 days ago.

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Treatment Details

Interventions

Orelabrutinib (ICP-022) (Tyrosine Kinase Inhibitor)

Trial OverviewThe study tests Orelabrutinib's safety and effectiveness in two parts: dose escalation to find the right amount of drug that can be given safely, followed by dose expansion to further assess its effects on patients with specific types of B-cell malignancies.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Part 2 Dose ExpansionExperimental Treatment1 Intervention

Arm 1: Patients with r/r MCL Arm 2: Patients with other types of B-cell malignancies, including: * CLL/SLL with/without prior treatment * r/r FL * r/r MZL

Group II: Part 1 Dose EscalationExperimental Treatment1 Intervention

Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL