A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)

Part of paid clinical trials in Newport Beach, California.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT04988555
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Leukemia, Lymphocytic, Acute
  • Leukemia, Myeloid, Acute
  • Multiple Myeloma
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enzomenib — DRUG
    DSP-5336 orally
  • azoles — DRUG
    Posaconazole, Voriconazole, or Fluconazole
  • Venetoclax — DRUG
    Venetoclax orally
  • Gilteritinib — DRUG
    Gilteritinib orally
  • Azacitidine (AZA) — DRUG
    Azacitidine orally
  • Intensive chemotherapy with 7 + 3 — DRUG
    chemotherapy

Study Details

A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in patients with acute leukemia.

Key Dates

Start date
Feb 28, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
606 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 - Arm A
    R/R acute leukemia without CYP3A4 inhibitor azoles
  • Experimental: Phase 1 - Arm B
    R/R acute leukemia with CYP3A4 inhibitor azoles
  • Experimental: Phase 1 - Arm C
    High-risk MDS after HMA
  • Experimental: Phase 1 - Arm D
    Patients with refractory MM
  • Experimental: Phase 1 - Arm E
    R/R AML with NPM1m or KMT2Ar
  • Experimental: Phase 1 - Arm F
    R/R AML with FLT3m + NPM1m or KMT2Ar
  • Experimental: Phase 2 - Arm G
    R/R AML with MLLr
  • Experimental: Phase 2 - Arm H
    R/R AML with NPM1m
  • Experimental: Phase 2 - Arm I
    R/R ALL with MLLr
  • Experimental: Phase 2 - Arm J
    R/R acute leukemia with MLLr
  • Experimental: Phase 2 - Arm K
    R/R AML with NPM1m
  • Experimental: Phase 1 - Arm L
    Newly diagnosed AML KMT2Ar FIT or UNFIT
  • Experimental: Phase 1 - Arm M
    Newly diagnosed AML NPM1m UNFIT only
  • Experimental: Phase 1 - Arm N
    Newly diagnosed AML with KMT2Ar or NPM1m

Primary Outcome Measure

Number of patients with adverse events and serious adverse events in Phase 1 [ Time Frame: 30 days from last dose ]

Central Contacts

Locations (33)

FacilityCityStateZIPSite coordinators
Hoag Family Cancer CenterNewport BeachCalifornia92663
Benjamin Goldenson, MD
[email protected]
Benjamin Goldenson, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Gabriel Mannis, MD
[email protected]
Colorado Blood Cancer InstituteDenverColorado80218
Alireza Eghtedar, MD
[email protected]
720-754-4800
Alireza Eghtedar, MD (PRINCIPAL_INVESTIGATOR)
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
SMPA Investigative Site
508-481-6700
Miami Cancer InstituteMiamiFlorida33176
SMPA Investigative Site
508-481-6700
University of MiamiMiamiFlorida33136
Justin Watts, MD
[email protected]
305-243-8986
Justin Watts, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
SMPA Investigative Site
508-481-6700
NorthwesternChicagoIllinois60611
Yasmin Abaza, MD
[email protected]
Yasmin Abaza, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Main CenterBaltimoreMaryland21287
Mark Levis, MD
[email protected]
Mark Levis, MD (PRINCIPAL_INVESTIGATOR)
Sibley Memorial HospitalBaltimoreMaryland20016
Mark Levis, MD
[email protected]
Mark Levis (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Maria Baer, MD
[email protected]
Maria Baer, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Andrew Brunner, MD
[email protected]
Andrew Brunner, MD (PRINCIPAL_INVESTIGATOR)
Tufts UniversityBostonMassachusetts02111-
Atlantic HealthMorristownNew Jersey07960
Mohamad Cherry, MD
[email protected]
Mohamad Cherry, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Neil Palmisiano, MD
[email protected]
Neil Palmisiano, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203
Eunice Wang, MD
[email protected]
Eunice Wang, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032-
Mount Sinai HospitalNew YorkNew York10029-
UNC HospitalChapel HillNorth Carolina27514
Joshua Zeidner, MD
[email protected]
Joshua Zeidner, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Harry Erba, MD
[email protected]
919-684-8964
Harry Erba, MD (PRINCIPAL_INVESTIGATOR)
Atrium Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Timothy Pardee, MD
[email protected]
Timothy Pardee, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Kristen Browning, MD
[email protected]
Kristen Browning, MD (PRINCIPAL_INVESTIGATOR)
Oncology Associates of OregonEugeneOregon97401
Luke Fletcher, MD
[email protected]
Luke Fletcher, MD (PRINCIPAL_INVESTIGATOR)
Sidney Kimmel Comprehensive Cancer CenterPhiladelphiaPennsylvania19107
Gina Keiffer, MD
[email protected]
Gina Keiffer, MD (PRINCIPAL_INVESTIGATOR)
Allegheny Health NetworkPittsburghPennsylvania15224
Salman Fazal, MD
[email protected]
Salman Fazal, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Praneeth Baratam, MD
[email protected]
Praneeth Baratam, MD (PRINCIPAL_INVESTIGATOR)
TriStar Centennial Medical CenterNashvilleTennessee37203
Stephen Strickland, MD
[email protected]
Stephen Strickland, MD (PRINCIPAL_INVESTIGATOR)
MDACCHoustonTexas77030
Naval Daver, MD
[email protected]
7137944392
Naval Daver, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer InstituteSalt Lake CityUtah84112
Paul Shami, MD
[email protected]
Paul Shami, MD (PRINCIPAL_INVESTIGATOR)
Intermountain HealthcareSalt Lake CityUtah84143
Bradley Hunter, MD
[email protected]
Bradley Hunter, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Michael Keng, MD
[email protected]
Michael Keng, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Mitul Gandhi, MD
[email protected]
Mitul Gandhi, MD (PRINCIPAL_INVESTIGATOR)
Virginia Oncology AssociatesNorfolkVirginia23502
Celeste Bremer, MD
[email protected]
Celeste Bremer, MD (PRINCIPAL_INVESTIGATOR)

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