HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
Stopped early · Phase 1
Conditions studied: Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome (MDS)
In brief
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.
Key facts
- Study ID
- NCT03940352
- Run by
- Novartis Pharmaceuticals
- People needed
- 52
- Starts
- 2019-06-24
- Expected to finish
- 2024-08-20
- Last updated by the study team
- 2025-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Duke University Medical Center . — Durham, North Carolina, United States
- Novartis Investigative Site — Melbourne, Victoria, Australia
- Novartis Investigative Site — Helsinki, Finland
- Novartis Investigative Site — Heidelberg, Germany
- Novartis Investigative Site — Würzburg, Germany
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Roma, RM, Italy
- Novartis Investigative Site — Singapore, Singapore
- Novartis Investigative Site — Madrid, Spain
Full record on ClinicalTrials.gov
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