Trials / Terminated
TerminatedNCT03940352
HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
A Phase Ib, Multi-arm, Open-label, Study of HDM201 in Combination With MBG453 or Venetoclax in Adult Subjects With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HDM201 | Capsule |
| BIOLOGICAL | MBG453 | LIVI (Liquid in vial) Concentrate for Solution for infusion |
| DRUG | Venetoclax | Tablet |
Timeline
- Start date
- 2019-06-24
- Primary completion
- 2024-08-20
- Completion
- 2024-08-20
- First posted
- 2019-05-07
- Last updated
- 2025-10-10
Locations
9 sites across 7 countries: United States, Australia, Finland, Germany, Italy, Singapore, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03940352. Inclusion in this directory is not an endorsement.