A Study of ICP-022 in Patients With R/R DLBCL

  • STATUS
    Recruiting
  • participants needed
    85
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 19 February 2024
lymphoma
b-cell lymphoma
diffuse large b-cell lymphoma
large b-cell lymphoma
btk inhibitor

Summary

It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.

Details
Condition Diffuse Large B-Cell Lymphoma
Age 18years - 75years
Treatment ICP-022
Clinical Study IdentifierNCT04438005
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women between 18 and 75 years old
Histologically confirmed diffuse large B-cell lymphomaDLBCLwith MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI
ECOG performance status of 0-2
Voluntary written informed consent prior to trail screening

Exclusion Criteria

History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry
History of Richter's syndrome
Current or history of lymphoma involved central nervous system
Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of study drug
The investigator considers other conditions unsuitable for this study
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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