81 Participants Needed

Orelabrutinib for B-Cell Malignancies

Recruiting at 38 trial locations
OY
Overseen ByOlivia Yang
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection)
Life expectancy (in the opinion of the investigator) of ≥ 4 months
I am fully active or can carry out light work.
See 4 more

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.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 involves dose escalation to determine the maximum tolerated dose (MTD) of Orelabrutinib

4 weeks
Multiple visits for dose escalation and monitoring

Dose Expansion

Part 2 involves dose expansion to assess anti-tumor activity in patients with B-cell malignancies

Up to 2 years
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Orelabrutinib (ICP-022)
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Part 2 Dose ExpansionExperimental Treatment1 Intervention
Group II: Part 1 Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beijing InnoCare Pharma Tech Co., Ltd.

Lead Sponsor

Trials
48
Recruited
6,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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