A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies
Overview
- Phase
- Phase 1
- Intervention
- Orelabrutinib (ICP-022)
- Conditions
- Part 1：r/r B-cell Malignancies
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Enrollment
- 81
- Locations
- 36
- Primary Endpoint
- Part 1 Dose Escalation：The maximum tolerated dose (MTD)
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent.
- •Age ≥ 18 years.
- •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.
- •Life expectancy (in the opinion of the investigator) of ≥ 4 months.
- •ECOG performance status of 0 \~
- •Must have adequate organ function.
- •Negative test results for HBV (\[HBsAg (-)\] and non-active HBV or HCV infection
Exclusion Criteria
- •Pregnant or breast-feeding or intending to become pregnant during the study.
- •Prior treatment with systemic immunotherapeutic agents.
- •Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
- •Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
- •History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
- •Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
- •Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.
- •Active uncontrolled infections.
- •Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.
- •Unresolved toxicities from prior anti-cancer therapy.
Arms & Interventions
Part 1 Dose Escalation
Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL
Intervention: Orelabrutinib (ICP-022)
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
Intervention: Orelabrutinib (ICP-022)
Outcomes
Primary Outcomes
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 MCL, r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
Secondary Outcomes
- Part 1 Dose Escalation：T1/2(Up to 2 years)
- Part 2 Dose Expansion：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability](Up to 2 years)
- Part 1 Dose Escalation：ORR(Up to 2 years)
- Part 2 Dose Expansion：DOR(Up to 2 years)
- Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability](Up to 2 years)