Clinical trial · Interventional
A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL
A Phase II, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Recurrent/Refractory Central Nervous System Lymphoma and Recurrent/Refractory Secondary Central Nervous System Lymphoma
NCT04438044CI-TRIAL-00061394unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCNSL | Primary Central Nervous System Lymphoma | ALIAS | 0.90 |
| Secondary Central Nervous System Lymphoma | Secondary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICP-022 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICP-022
- description
- 150mg,QD
- interventionNames
- Drug: ICP-022
Primary outcomes (1)
- measure
- The efficacy measured by overall response rate (ORR)
- timeFrame
- Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
Secondary outcomes (3)
- measure
- The occurrence of adverse events and serious adverse events
- timeFrame
- every cycle, first cycle every week. Each cycle is 28 days
- description
- The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 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 ≥ 18, and ≤75 years of age 2. Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL. 3. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments. 4. ECOG performance status of 0-2 5. Able to provide signed written informed consent Key Exclusion Criteria: 1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded 2. T-cell lymphoma. 3. Patient requires more than 8 mg of dexamethasone daily or the equivalent. 4. Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia) 5. Known active infection with HBV, HCV or HIV. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.