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NCT04609826: DHODH

A Study of JNJ-74856665 in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Completed Phase 1 Last updated 1 October 2025
What this trial tests

Phase 1 trial testing JNJ-74856665 in Acute Myeloid Leukemia in 153 participants. Completed in 25 August 2025.

Timeline
26 November 2020
Primary endpoint
25 August 2025
25 August 2025

Quick facts

Lead sponsorJanssen Research & Development, LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment153
Start date26 November 2020
Primary completion25 August 2025
Estimated completion25 August 2025
Sites20 locations across France, United Kingdom, Spain, South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the safety, tolerability, maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of JNJ-74856665 as monotherapy and/or in combinations.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
    Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
  2. Nucleotide metabolism: a pan-cancer metabolic dependency.
    Mullen NJ, Singh PK. · · 2023 · cited 308× · PMID 36973407 · DOI 10.1038/s41568-023-00557-7
  3. Recent advances in targeted therapies in acute myeloid leukemia.
    Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
  4. Small-molecule agents for cancer immunotherapy.
    Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010
  5. DHODH inhibition enhances the efficacy of immune checkpoint blockade by increasing cancer cell antigen presentation.
    Mullen NJ, Shukla SK, Shukla SK, Thakur R, et al · · 2024 · cited 28× · PMID 38973593 · DOI 10.7554/elife.87292
  6. ENT1 blockade by CNX-774 overcomes resistance to DHODH inhibition in pancreatic cancer.
    Mullen NJ, Thakur R, Shukla SK, Chaika NV, et al · · 2023 · cited 22× · PMID 36341997 · DOI 10.1016/j.canlet.2022.215981
  7. Targeting Acute Myelogenous Leukemia Using Potent Human Dihydroorotate Dehydrogenase Inhibitors Based on the 2-Hydroxypyrazolo[1,5-<i>a</i>]pyridine Scaffold: SAR of the Aryloxyaryl Moiety.
    Sainas S, Giorgis M, Circosta P, Poli G, et al · · 2022 · cited 17× · PMID 36162075 · DOI 10.1021/acs.jmedchem.2c00496
  8. Epigenetics in a Spectrum of Myeloid Diseases and Its Exploitation for Therapy.
    Maher M, Diesch J, Le Pannérer MM, Buschbeck M. · · 2021 · cited 10× · PMID 33917538 · DOI 10.3390/cancers13071746

Verify or expand the search:

Other trials of JNJ-74856665

Trials testing the same drug.

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04609826.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing