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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04014205
Recruitment Status : Active, not recruiting
First Posted : July 10, 2019
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Part 1：r/r B-cell Malignancies Part 2：B-cell Malignancies Drug: Orelabrutinib (ICP-022) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 30, 2025
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Part 1 Dose Escalation：The maximum tolerated dose (MTD) [ Time Frame: Incidence of dose limiting toxicities (DLTs) up to 28 days ]
    To determine the maximum tolerated dose (MTD)

  2. Part 2 Dose Expansion：ORR [ Time Frame: Up to 2 years ]
    To assess anti-tumor activity of Orelabrutinib (ICP-022) in Patients with B-cell malignancies including r/r MCL, r/r FL, r/r MZL and CLL/SLL with/without prior treatment.


Secondary Outcome Measures :
  1. Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability] [ Time Frame: Up to 2 years ]
    The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed

  2. Part 1 Dose Escalation：ORR [ Time Frame: Up to 2 years ]
    Objective response rate

  3. Part 1 Dose Escalation：T1/2 [ Time Frame: Up to 2 years ]
    Elimination half-life

  4. Part 2 Dose Expansion：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability] [ Time Frame: Up to 2 years ]
    The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed

  5. Part 2 Dose Expansion：DOR [ Time Frame: Up to 2 years ]
    Duration of response


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014205


Locations
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Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
More Information
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Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04014205    
Other Study ID Numbers: ICP-CL-00107
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms