A Study of ICP-022 in Patients With R/R DLBCL
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ICP-022
|
Drug: ICP-022
ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
|
Outcome Measures
Primary Outcome Measures
- Overall response rate（ORR） [Up to 3 years]
The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL
Secondary Outcome Measures
- Occurrence of adverse events and serious adverse events [Up to 3 years]
The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria
- Progression free survival（PFS） [Up to 3 years]
The efficacy measured by progression free survival（PFS）
- Duration of response（DOR） [Up to 3 years]
Eligibility Criteria
Criteria
Key Inclusion criteria：
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Men and women between 18 and 75 years old,
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Histologically confirmed diffuse large B-cell lymphoma（DLBCL）with MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI,
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ECOG performance status of 0-2,
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Voluntary written informed consent prior to trail screening.
Key Exclusion criteria:
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History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry
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History of Richter's syndrome
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Current or history of lymphoma involved central nervous system
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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.
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The investigator considers other conditions unsuitable for this study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Tumor Hospital of Harbin Medical University | Haerbin | Heilongjiang | China | |
| 2 | Jiangsu Province Hospital | Nanjing | Jiangsu | China | |
| 3 | Shengjing Hospital of China Medical University | Shenyang | Liaoning | China | |
| 4 | The Fourth Hospital of Hebei Medical University | Hebei | Shijiazhuang | China | |
| 5 | Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) | Tianjin | Tianjin | China | |
| 6 | The First Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Beijing InnoCare Pharma Tech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICP-CL-00108