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NCT04014205 · ClinicalTrials.gov registry record · Phase 1
A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
A Phase 1 study, sponsored by Beijing InnoCare Pharma Tech Co..
- Active
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT04014205: Active Phase 1 study, sponsored by Beijing InnoCare Pharma Tech Co..
NCT04014205 is a Phase 1 study that is active but no longer recruiting, run by Beijing InnoCare Pharma Tech Co.. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04014205, a Phase 1 study, is active but no longer recruiting, sponsored by Beijing InnoCare Pharma Tech Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
Primary Outcome
To determine the maximum tolerated dose (MTD)
Interventions
- DRUG Orelabrutinib (ICP-022)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT04014205 still lists
NCT04014205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which Orelabrutinib (ICP-022) is the first listed.
NCT04014205 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04014205 about?
NCT04014205 is a clinical study titled "A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies". This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
What is the current status of trial NCT04014205?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2019-11-18. Estimated completion is 2026-06-30.
What interventions are being tested in trial NCT04014205?
The interventions under investigation include: Orelabrutinib (ICP-022) (DRUG).
Who is sponsoring clinical trial NCT04014205?
This trial is sponsored by Beijing InnoCare Pharma Tech Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04014205's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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