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

NCT03940352 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-10-10

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

HDM201

Capsule

BIOLOGICAL

MBG453

LIVI (Liquid in vial) Concentrate for Solution for infusion

DRUG

Venetoclax

Tablet

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2024-08-20
Completion
2024-08-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Finland
  • Germany
  • Italy
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940352 on ClinicalTrials.gov