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

NCT04014205 | Unknown Phase 1 FDA Drug

• 1 other identifier: ICP-CL-00107
• Study Type: interventional
• Target: 81
• Locations: 4 countries
• Sites: 36

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).

Conditions

Part 1：r/r B-cell Malignancies; Part 2：B-cell Malignancies

Outcome Measures

Primary Outcomes (2)

• Part 1 Dose Escalation：The maximum tolerated dose (MTD)

  To determine the maximum tolerated dose (MTD)

  Incidence of dose limiting toxicities (DLTs) up to 28 days

• Part 2 Dose Expansion：ORR

  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.

  Up to 2 years

Secondary Outcomes (5)

• Part 1 Dose Escalation：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 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 2 Dose Expansion：DOR

  Up to 2 years

Study Arms (2)

Part 1 Dose Escalation

EXPERIMENTAL

Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL

Drug: Orelabrutinib (ICP-022)

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

Drug: Orelabrutinib (ICP-022)

Interventions

Orelabrutinib (ICP-022) DRUG

ICP-022 The drug product is a white, round, uncoated tablet

Part 1 Dose Escalation; Part 2 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \~1.
• Must have adequate organ function.
• Negative test results for HBV (\[HBsAg (-)\] and non-active HBV or HCV infection

You may not qualify if:

• 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.
• Medically apparent CNS lymphoma or leptomeningeal disease.
• Current or previous history of CNS disease.
• Major surgery or significant traumatic injury \< 28 days prior to the first dose of the study drug.
• Patients with another invasive malignancy in the last 2 years.
• Significant cardiovascular disease or active pulmonary disease.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (36)

Mayo Clinic-Mayo Clinic Hospital-Phoenix

Phoenix, Arizona, 85054-4502, United States

Location

Pacific Cancer Medical Center

Anaheim, California, 92801-1824, United States

Location

Los Angeles Cancer Network - Good Samaritan Hospital Location

Los Angeles, California, 90017, United States

Location

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California, 92270, United States

Location

The Oncology Institute of Hope & Innovation

Whittier, California, 90603, United States

Location

Florida Cancer Specialists (FCS) South

Fort Myers, Florida, 33901, United States

Location

Asclepes Research Centers - Weeki Wachee

Weeki Wachee, Florida, 34607, United States

Location

Northwest Neurology - Rolling Meadows Office

Elk Grove Village, Illinois, 60007, United States

Location

Orchard Healthcare Research Inc.

Skokie, Illinois, 60077, United States

Location

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)

Topeka, Kansas, 66606, United States

Location

Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC

New Orleans, Louisiana, 70112, United States

Location

Anne Arundel Medical Center (AAMC) Oncology and Hematology

Annapolis, Maryland, 21401-3093, United States

Location

Mayo Clinic - Minnesota

Rochester, Minnesota, 55905-0001, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

Southeast Nebraska Cancer Center

Lincoln, Nebraska, 68510-2496, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932-0001, United States

Location

Clinical Research Alliance

Westbury, New York, 11590, United States

Location

Gabrail Cancer Research Center

Canton, Ohio, 44718, United States

Location

University of Pittsburgh - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Guthrie Cancer Center

Sayre, Pennsylvania, 18840, United States

Location

Prairie Lakes Cancer Center

Watertown, South Dakota, 57201, United States

Location

Tennessee Oncology - Chattanooga Oncology & Hematology Associates

Chattanooga, Tennessee, 37404-1130, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909-1327, United States

Location

Sarah Cannon Research Institute - Tennessee Oncology

Nashville, Tennessee, 37203-1625, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Medical Oncology Associates PS (dba Summit Cancer Centers)

Spokane, Washington, 99201, United States

Location

Soroka Medical Center

Beersheba, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Cherkassy Regional Oncology Center

Cherkasy, Ukraine

Location

Khmelnytskyi Regional Hospital

Khmelnytskyi, Ukraine

Location

St. Luke's Hospital - Medical and Diagnostic Center

Kropyvnytskyi, Ukraine

Location

National Cancer Institute

Kyiv, Ukraine

Location

Institute of Blood Pathology and Transfusion Medicine

Lviv, Ukraine

Location

Transcarpathian Regional Clinical Hospital named after Andrii Novak

Uzhhorod, Ukraine

Location

MeSH Terms

Interventions

orelabrutinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 10, 2019
• Study Start: November 18, 2019
• Primary Completion: December 31, 2023
• Study Completion: January 30, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (27); PL (1); IL (2); UA (6)