A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies

Purpose

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).

Conditions

  • Part 1：r/r B-cell Malignancies
  • Part 2：B-cell Malignancies

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Signed Informed Consent. 2. Age ≥ 18 years. 3. Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL. Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment. 4. Life expectancy (in the opinion of the investigator) of ≥ 4 months. 5. ECOG performance status of 0 ~1. 6. Must have adequate organ function. 7. Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection

Exclusion Criteria

  1. Pregnant or breast-feeding or intending to become pregnant during the study. 2. Prior treatment with systemic immunotherapeutic agents. 3. Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV. 4. Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug. 5. History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML. 6. Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug. 7. Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor. 8. Active uncontrolled infections. 9. Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug. 10. Unresolved toxicities from prior anti-cancer therapy. 11. Medically apparent CNS lymphoma or leptomeningeal disease. 12. Current or previous history of CNS disease. 13. Major surgery or significant traumatic injury < 28 days prior to the first dose of the study drug. 14. Patients with another invasive malignancy in the last 2 years. 15. Significant cardiovascular disease or active pulmonary disease. 16. Received systemic immunosuppressive medications.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Dose Escalation 		Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL
  • Drug: Orelabrutinib (ICP-022)
    ICP-022 The drug product is a white, round, uncoated tablet
Experimental
Part 2 Dose Expansion 		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
  • Drug: Orelabrutinib (ICP-022)
    ICP-022 The drug product is a white, round, uncoated tablet

More Details

Status
Active, not recruiting
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

Study Contact