Clinical trial · Interventional
A Study of ICP-022 in Patients With R/R DLBCL
A Multicenter, Open-Label Study to Investigate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICP-022 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICP-022
- interventionNames
- Drug: ICP-022
Primary outcomes (1)
- measure
- Overall response rate（ORR）
- timeFrame
- Up to 3 years
- description
- The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL
Secondary outcomes (3)
- measure
- Occurrence of adverse events and serious adverse events
- timeFrame
- Up to 3 years
- description
- The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Key Inclusion criteria： 1. Men and women between 18 and 75 years old, 2. 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, 3. ECOG performance status of 0-2, 4. Voluntary written informed consent prior to trail screening. Key Exclusion criteria: 1. History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry 2. History of Richter's syndrome 3. Current or history of lymphoma involved central nervous system 4. 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. 5. The investigator considers other conditions unsuitable for this study. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
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