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NCT04260217 · ClinicalTrials.gov registry record · Phase 1
APG-2575 Single Agent or in Combination With Ibrutinib or Rituximab in Patients With Waldenström Macroglobulinemia
A Phase 1 study, sponsored by Ascentage Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT04260217: Completed Phase 1 study, sponsored by Ascentage Pharma Group.
NCT04260217 is a Phase 1 study that has completed, run by Ascentage Pharma Group. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04260217, a Phase 1 study, has completed, sponsored by Ascentage Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
Phase Ib/II study of safety, tolerability, efficacy and PK of APG-2575 as a single agent or in combination with other therapeutic agents including ibrutinib or rituximab.
Primary Outcome
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0
Interventions
- DRUG APG2575 400 mg
- DRUG APG2575 600 mg
- DRUG APG2575 800 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-05-30 |
| Est. Completion | 2025-08-13 |
| Phase | Phase 1 |
What the finished NCT04260217 record still lists
NCT04260217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which APG2575 400 mg is the first listed.
NCT04260217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04260217 about?
NCT04260217 is a clinical study titled "APG-2575 Single Agent or in Combination With Ibrutinib or Rituximab in Patients With Waldenström Macroglobulinemia". Phase Ib/II study of safety, tolerability, efficacy and PK of APG-2575 as a single agent or in combination with other therapeutic agents including ibrutinib or rituximab.
What is the current status of trial NCT04260217?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2021-05-30. Estimated completion is 2025-08-13.
What interventions are being tested in trial NCT04260217?
The interventions under investigation include: APG2575 400 mg (DRUG), APG2575 600 mg (DRUG), APG2575 800 mg (DRUG).
Who is sponsoring clinical trial NCT04260217?
This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04260217's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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