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

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

Study Description
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, 2021
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment 1 (Orelabrutinib)
Patients with r/r MCL receive Orelabrutinib
 Drug: Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
Experimental: Treatment 2 (Orelabrutinib)
Patients with other types of B-cell malignancies, including:CLL/SLL with/without prior treatment, r/r FL, r/r MZL receive Orelabrutinib
 Drug: Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
Outcome Measures
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 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

Contacts
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Contact: Olivia Yang +1 (609) 524-0684 ClinicalTrialsInfo@innocarepharma.com

Locations
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United States, Louisiana
Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Saba Nakhle         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Yucai Wang         
United States, Montana
St Vincent Frontier Cancer Center Recruiting
Billings, Montana, United States, 59101
Contact: Cobb W Patrick         
United States, New Jersey
Summit Medical Group Recruiting
Florham Park, New Jersey, United States, 07932
Contact: Gallinson H David         
United States, New York
Clinical Research Alliance Recruiting
New Hyde Park, New York, United States, 11040
Contact: Coleman Morton         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Michael (Luhua) Wang         
Contact    713-792-2860    miwang@mdanderson.org   
United States, Washington
Medical Oncology Associates PS (dba Summit Cancer Centers) Recruiting
Spokane, Washington, United States, 99201
Contact: Chaudhry Arvind         
Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date May 26, 2021
Actual Study Start Date  ICMJE November 18, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2021)
  • 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)
  • 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 FL, r/r MZL and CLL/SLL with/without prior treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		The maximum tolerated dose (MTD) [ Time Frame: Incidence of dose limiting toxicities (DLTs) up to 28 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2021)
  • 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
  • Part 1 Dose Escalation：ORR [ Time Frame: Up to 2 years ]
    Objective response rate
  • Part 1 Dose Escalation：T1/2 [ Time Frame: Up to 2 years ]
    Elimination half-life
  • 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
  • Part 2 Dose Expansion：DOR [ Time Frame: Up to 2 years ]
    Duration of response
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: July 9, 2019)
  • Objective response rate (ORR) [ Time Frame: Up to 2 years ]
    ORR of ICP-022 will be assessed by the investigator using standard criteria for Non-Hodgkin's lymphoma [2014 Lugano Classification criteria International working group non-hodgkin's lymphoma (IWGNHL) (Cheson et al., 2014) and the International Workshop on Chronic Lymphocytic Leukemia (IWCLL), (Hallek et al., 2008)]
  • Elimination half-life (T1/2) [ Time Frame: 28 days/cycle, Cycle1 Day 1 and Day 8 pre-dose (-10 minutes), 15 minutes, 30 minutes, 1, 2, 4, 8 and 24 hours (before dosing on next day) after study medication administration; Cycle2 Day1 pre-dose (-10 minutes) ]
  • Total plasma exposure - Area under the concentration time curve (AUC) [ Time Frame: 28 days/cycle, Cycle1 Day 1 and Day 8 pre-dose (-10 minutes), 15 minutes, 30 minutes, 1, 2, 4, 8 and 24 hours (before dosing on next day) after study medication administration; Cycle Day1 pre-dose (-10 minutes) ]
  • Time to reach maximum observed plasma concentration (Tmax) [ Time Frame: 28 days/cycle, Cycle1 Day 1 and Day 8 pre-dose (-10 minutes), 15 minutes, 30 minutes, 1, 2, 4, 8 and 24 hours (before dosing on next day) after study medication administration; Cycle2 Day1 pre-dose (-10 minutes) ]
  • Maximum plasma concentration observed (Cmax) [ Time Frame: 28 days/cycle, Cycle 1 Day 1 and Day 8 pre-dose (-10 minutes), 15 minutes, 30 minutes, 1, 2, 4, 8 and 24 hours (before dosing on next day) after study medication administration; Cycle 2 Day1 pre-dose (-10 minutes) ]
  • Minimum plasma concentration (Cmin) under steady-state conditions within a dosing interval [ Time Frame: 28 days/cycle, Cycle1 Day 1 and Day 8 pre-dose (-10 minutes), 15 minutes, 30 minutes, 1, 2, 4, 8 and 24 hours (before dosing on next day) after study medication administration; Cycle2 Day1 pre-dose (-10 minutes) ]
  • clearance (CL) [ Time Frame: 28 days/cycle, Cycle1 Day 1 and Day 8 pre-dose (-10 minutes), 15 minutes, 30 minutes, 1, 2, 4, 8 and 24 hours (before dosing on next day) after study medication administration; Cycle2 Day1 pre-dose (-10 minutes) ]
  • Volume of distribution at steady-state (Vss) [ Time Frame: 28 days/cycle, Cycle 1 Day 1 and Day 8 pre-dose (-10 minutes), 15 minutes, 30 minutes, 1, 2, 4, 8 and 24 hours (before dosing on next day) after study medication administration; Cycle2 Day1 pre-dose (-10 minutes) ]
 
Descriptive Information
Brief Title  ICMJE A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
Official Title  ICMJE A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Part 1：r/r B-cell Malignancies
  • Part 2：B-cell Malignancies
Intervention  ICMJE Drug: Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
Study Arms  ICMJE
  • Experimental: Treatment 1 (Orelabrutinib)
    Patients with r/r MCL receive Orelabrutinib
    Intervention: Drug: Orelabrutinib (ICP-022)
  • Experimental: Treatment 2 (Orelabrutinib)
    Patients with other types of B-cell malignancies, including:CLL/SLL with/without prior treatment, r/r FL, r/r MZL receive Orelabrutinib
    Intervention: Drug: Orelabrutinib (ICP-022)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2021) 		81
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		15
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Olivia Yang +1 (609) 524-0684 ClinicalTrialsInfo@innocarepharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014205
Other Study ID Numbers  ICMJE ICP-CL-00107
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing InnoCare Pharma Tech Co., Ltd.
Study Sponsor  ICMJE Beijing InnoCare Pharma Tech Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing InnoCare Pharma Tech Co., Ltd.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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