Clinical Trials /

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

NCT04014205

Description:

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).

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
  • Official Title: A Phase I/II,Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies

Clinical Trial IDs

  • ORG STUDY ID: ICP-CL-00107
  • NCT ID: NCT04014205

Conditions

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

Interventions

DrugSynonymsArms
Orelabrutinib (ICP-022)Part 1 Dose Escalation

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).

Trial Arms

NameTypeDescriptionInterventions
Part 1 Dose EscalationExperimentalPatients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL
  • Orelabrutinib (ICP-022)
Part 2 Dose ExpansionExperimentalArm 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
  • Orelabrutinib (ICP-022)

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1 Dose Escalation:The maximum tolerated dose (MTD)
Time Frame:Incidence of dose limiting toxicities (DLTs) up to 28 days
Safety Issue:
Description:To determine the maximum tolerated dose (MTD)

Secondary Outcome Measures

Measure:Part 1 Dose Escalation:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
Time Frame:Up to 2 years
Safety Issue:
Description:The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
Measure:Part 1 Dose Escalation:ORR
Time Frame:Up to 2 years
Safety Issue:
Description:Objective response rate
Measure:Part 1 Dose Escalation:T1/2
Time Frame:Up to 2 years
Safety Issue:
Description:Elimination half-life
Measure:Part 2 Dose Expansion:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
Time Frame:Up to 2 years
Safety Issue:
Description:The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
Measure:Part 2 Dose Expansion:DOR
Time Frame:Up to 2 years
Safety Issue:
Description:Duration of response

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Beijing InnoCare Pharma Tech Co., Ltd.

Last Updated

July 29, 2021