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

ICP-CL-00105

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.

2019-08-10

2024-01-09

2024-01-09

Completed

Early phase I

47

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 47, 'type': 'ACTUAL'}}

2024-04-18