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

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.

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.