HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03940352
Phase
PHASE1
Status
Terminated

Conditions

  • Acute Myeloid Leukemia (AML)
  • High-risk Myelodysplastic Syndrome (MDS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HDM201 — DRUG
    Capsule
  • MBG453 — BIOLOGICAL
    LIVI (Liquid in vial) Concentrate for Solution for infusion
  • Venetoclax — DRUG
    Tablet

Study Details

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 Dates

Start date
Jun 24, 2019
Status verified
Oct 2025
Primary completion
Aug 20, 2024
Completion
Aug 20, 2024

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: treatment arm1: HDM201+MBG453
    Phase Ib (escalation)
  • Experimental: treatment arm2: HDM201+venetoclax
    Phase Ib (escalation)

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety [ Time Frame: at month 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical Center .DurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center .· Durham, NC

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