Participant flow

AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia · Source last updated 2025-07-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received intravenous (IV) AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.

   id

   FG000

   title

   Part 1A Dose Exploration: AMG 176 Dose Level 1

2. description

   Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.

   id

   FG001

   title

   Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Sponsor decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The study was planned to be conducted in 3 parts and was discontinued early after the completion of Part 1A (dose exploration). Part 1B (dose escalation/de-escalation) and Part 3 (dose expansion) were not conducted and did not enroll any participants. Dose level 1 is a low dose and Dose level 2 is a high dose.

recruitment Details

A total of 7 participants with higher risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia were enrolled at a single study center in the United States from November 2022 and the last participant's last visit was in December 2023.

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Preserved source evidence · Not medical advice