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

Phase 1

Active, not recruiting

• Conditions: Part 2：B-cell Malignancies; Part 1：r/r B-cell Malignancies
• Interventions: Drug: Orelabrutinib (ICP-022)

• Registration Number: NCT04014205
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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 available

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-10
• Study Start: 2019-11-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-12-31
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2 Dose Expansion	Orelabrutinib (ICP-022)	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
Part 1 Dose Escalation	Orelabrutinib (ICP-022)	Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL

Primary Outcome Measures

Name	Time	Method
Part 1 Dose Escalation：The maximum tolerated dose (MTD)	Incidence of dose limiting toxicities (DLTs) up to 28 days	To determine the maximum tolerated dose (MTD)
Part 2 Dose Expansion：ORR	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

Name	Time	Method
Part 2 Dose Expansion：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]	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	Up to 2 years	Objective response rate
Part 2 Dose Expansion：DOR	Up to 2 years	Duration of response
Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]	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：T1/2	Up to 2 years	Elimination half-life

Trial Locations

Locations (36)

Mayo Clinic-Mayo Clinic Hospital-Phoenix; 🇺🇸 Phoenix, Arizona, United States

Pacific Cancer Medical Center; 🇺🇸 Anaheim, California, United States

Los Angeles Cancer Network - Good Samaritan Hospital Location; 🇺🇸 Los Angeles, California, United States

Desert Hematology Oncology Medical Group, Inc.; 🇺🇸 Rancho Mirage, California, United States

The Oncology Institute of Hope & Innovation; 🇺🇸 Whittier, California, United States

Florida Cancer Specialists (FCS) South; 🇺🇸 Fort Myers, Florida, United States

Asclepes Research Centers - Weeki Wachee; 🇺🇸 Weeki Wachee, Florida, United States

Northwest Neurology - Rolling Meadows Office; 🇺🇸 Elk Grove Village, Illinois, United States

Orchard Healthcare Research Inc.; 🇺🇸 Skokie, Illinois, United States

Goshen Center for Cancer Care; 🇺🇸 Goshen, Indiana, United States

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