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).
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
Drug | Synonyms | Arms |
---|
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
Name | Type | Description | Interventions |
---|
Part 1 Dose Escalation | Experimental | Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL | |
Part 2 Dose Expansion | Experimental | 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 | |
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