A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia

April 17, 2024 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
    • Beijing
      • Beijing, Beijing, China, 100000
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Chengdu
      • Sichuan, Chengdu, China
        • West China Hospital of Sichuan University
    • Fujian
      • Fuzhou, Fujian, China
        • Union Hospital Affiliated to Fujian Medical University
      • Xiamen, Fujian, China
        • The First Affiliated Hospital of Xiamen University
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China
        • Henan Provincial Peoples's Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital affiliated to Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Suzhou, Jiangsu, China
        • The First Affiliated Hospital of Soochow University
    • Liaoning
      • Shenyang, Liaoning, China
        • Shengjing Hospital of China Medical University
    • Shanghai
      • Shanghai, Shanghai, China
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University
    • Tianjin
      • Tianjin, Tianjin, China
        • Hospital of Hematology, Chinese Academy of Medical Sciences
    • Wuhan
      • Hubei, Wuhan, China
        • Union Hospital affiliated to Huazhong University of Science and Technology
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of Zhejiang University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion criteria:

  1. Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003)
  2. At least one treatment indication is met (7th WM International Working Group standards, IWWM-7) (Dimopoulos et al., 2014)
  3. With the lowest serum IgM value >2 times ULN as the efficacy evaluation index
  4. ECOG physical strength score 0-2
  5. Voluntary written informed consent prior to trial screening.

Key Exclusion Criteria:

  1. Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
  2. Amyloidosis and central nervous system (CNS) involvement caused by WM
  3. Demonstrate disease transformation
  4. Patients who had received autologous stem cell transplantation within the previous 6 months
  5. A history of organ transplantation or allogeneic bone marrow transplantation

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICP-022
Subjects will take ICP-022 150mg once daily (QD).
Drug: ICP-022
ICP-022 at a dose of 150mg PO QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major response rate（MRR）
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of adverse events and serious adverse events
Time Frame: Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.
The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria
Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.
Duration of Major Mitigation (DOMR)
Time Frame: Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.
Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.
Progression Free Survival (PFS)
Time Frame: Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.
Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2019

Primary Completion (Actual)

January 9, 2024

Study Completion (Actual)

January 9, 2024

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-CL-00105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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