deltatrials
Terminated PHASE1 INTERVENTIONAL 1-arm NCT02353143

Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia (ARMY)

First in Man Study With MEN1112, a CD157 Targeted Monoclonal Antibody, in Relapsed or Refractory Acute Myeloid Leukemia.

Sponsor: Menarini Group

Interventions MEN1112
Updated 18 times since 2017 Last updated: Mar 12, 2024 Started: Dec 31, 2014 Primary completion: Apr 9, 2021 Completion: Apr 9, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The Sponsor accepted the iDSMB recommendation to terminate the study due to evidence of unpredictable liver toxicity and meaningful target engagement not translating into any clinical objective response.

This PHASE1 trial investigates Acute Myeloid Leukemia, in Relapse and Recurrent Adult Acute Myeloid Leukemia and is currently terminated or withdrawn. Menarini Group leads this study, which shows 18 recorded versions since 2014 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Feb 2019 · 3 months · monthly snapshot~Feb 2019 – ~Nov 2020 · 21 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Jun 2021 · 3 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

18 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE1

  5. Sep 2021 — Dec 2021 [monthly]

    Terminated PHASE1

    Status: Active Not RecruitingTerminated

Show 13 earlier versions
  1. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  2. Mar 2021 — Jun 2021 [monthly]

    Recruiting PHASE1

    Status: Unknown StatusRecruiting

  3. Jan 2021 — Mar 2021 [monthly]

    Unknown Status PHASE1

  4. Nov 2020 — Jan 2021 [monthly]

    Unknown Status PHASE1

    Status: RecruitingUnknown Status

  5. Feb 2019 — Nov 2020 [monthly]

    Recruiting PHASE1

  6. Nov 2018 — Feb 2019 [monthly]

    Recruiting PHASE1

    Status: Active Not RecruitingRecruiting

  7. Sep 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  8. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE1

  9. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE1

  10. Jul 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  11. May 2017 — Jul 2017 [monthly]

    Recruiting PHASE1

  12. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE1

  13. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Dec 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Menarini Group
Data source: Menarini Group

For direct contact, visit the study record on ClinicalTrials.gov .