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NCT03940352 · ClinicalTrials.gov registry record · Phase 1
HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT03940352 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 52 participants.
The verdict
NCT03940352, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This was a phase 1b, multi-arm, open-label study of HDM201 in combination with MBG453 or venetoclax in subjects with AML or high-risk MDS. For all subjects, TP53wt status had to be characterized by, at a minimum, no mutations noted in exons 5, 6, 7 and 8. Two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity of HDM201+MBG453 (treatment arm 1) and HDM201+venetoclax (treatment arm 2). * In the treatment arm 1, subjects received HDM201 in combination with MBG453. * In the treatment arm 2, subjects received HDM201 in combination with venetoclax. Venetoclax dose was gradually increased (ramp-up) over a period of 4 to 5 days to achieve the daily target dose tested that was subsequently continued. Upon the completion of the escalation part, MTD(s) and/or RD(s) of HDM201 in combination with MBG453 or venetoclax in AML and high-risk MDS subjects was planned to be determined for each treatment arm.
Interventions
- DRUG Venetoclax
- DRUG HDM201
- BIOLOGICAL MBG453
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2024-08-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03940352
The ClinicalTrials.gov registry entry for NCT03940352 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT03940352 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03940352 about?
NCT03940352 is a clinical study titled "HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)". This was a phase 1b, multi-arm, open-label study of HDM201 in combination with MBG453 or venetoclax in subjects with AML or high-risk MDS. For all subjects, TP53wt status had to be characterized by, at a minimum, no mutations noted in exons 5, 6, 7 and 8. Two treatment arms enrolled subjects in pa...
What is the current status of trial NCT03940352?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2019-06-24. Estimated completion is 2024-08-20.
What interventions are being tested in trial NCT03940352?
The interventions under investigation include: Venetoclax (DRUG), HDM201 (DRUG), MBG453 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03940352?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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