Trial · NCT04988555
A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)
NCT04988555, Phase 1, Phase 2, Recruiting, Sumitomo Pharma America, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1). Trials, record NCT04988555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04988555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)
- NCT number
- NCT04988555
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 606 participants, estimated
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute, Multiple Myeloma, Myelodysplastic Syndromes
- Interventions
- Enzomenib, azoles, Venetoclax, Gilteritinib, Azacitidine (AZA), Intensive chemotherapy with 7 + 3
- First posted
- 2021-08-03
- Last updated
- 2026-03-24
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of patients with adverse events and serious adverse events in Phase 1 | 30 days from last dose | Assessment of safety of DSP-5336 administered in participants with advanced hematologic malignancies by reporting of adverse events and serious adverse events in Phase 1 |
| Primary | Determination of Recommended Phase 2 Dose (RP2D) | Within 4 months from first dose | The RP2D is based on adverse events, pharmacokinetics, and clinical response |
| Primary | Determination of Recommended Phase 2 Dose (RP2D) for patients with relapse and refractory AML who are enrolled into the combination venetoclax and azacitidine arm | Within 4 months from first dose | The RP2D is based on adverse events, pharmacokinetics, and clinical response |
| Primary | Determination of Recommended Phase 2 Dose (RP2D) for patients with relapse and refractory AML who are enrolled into the gilteritinib arm | Within 4 months from first dose | The RP2D is based on assessment of Dose Limiting Toxicities |
| Primary | Optimal dose of DSP-5336 (RP2D) for patients newly diagnosed with AML enrolled into the combination venetoclax and azacitidine arm | Within 4 months from the first dose | The RP2D is based on adverse events, pharmacokinetics and clinical response |
| Primary | Determination of Recommended Phase 2 Dose (RP2D) for patients enrolled into the 7 + 3 arm | Within 4 months from first dose | The RP2D is based on assessment of Dose Limiting Toxicities |
| Primary | Number of patients achieving complete response (CR) and complete response with partial hematologic recovery (CRh) in Phase 2 | Approximately 6 months after first dose | Disease response defined by the FDA guidance and ELN2017 |
| Secondary | The maximum observed concentration (Cmax) of of DSP-5336, venetoclax and gilteritinib | Approximately 3 months after first dose | Cmax of DSP-5336, venetoclax and gilteritinib are calculated from the individual concentration time curve |
| Secondary | Area under the plasma concentration vs. time curve (AUClast) of DSP-5336, venetoclax and gilteritinib | Approximately 3 months after first dose | The determination of AUClast using the linear/log trapezoidal rule |
| Secondary | T(1/2) of DSP-5336, venetoclax and gilteritinib | Approximately 3 months after first dose | Elimination half-life (t\[1/2\]) of DSP-5336, venetoclax and gilteritinib |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04988555
GET https://conductscience.org/api/trials/v1/NCT04988555/registered