Study of REM-422 in Patients With AML or Higher Risk MDS

Part of paid clinical trials in Duarte, California.

Sponsor
Remix Therapeutics
Study ID
NCT06297941
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Refractory
  • Higher Risk Myelodysplastic Syndromes
  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

  • REM-422 — DRUG
    REM-422 is a first in class, small molecule mRNA inhibitor that reduces expression of the MYB transcription factor REM-422 will be administered orally once daily

Study Details

The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML

Key Dates

Start date
Apr 26, 2024
Status verified
Apr 2025
Primary completion
Mar 15, 2026
Completion
Jun 15, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: REM-422
    Dose Escalation: Participants will receive escalating doses of REM-422 to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)-422, oral capsule administered once daily Dose Expansion: Participants will receive REM-422 at the identified RP2D Treatment will continue until disease progression, therapy intolerance, or participant withdrawal Safety evaluation will continue until 30 days of last administration of REM-422

Primary Outcome Measure

Frequency and severity of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 24 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Anthony S Stein, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Onyee Chan, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Amir Fathi, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan KetteringNew YorkNew York10065
Eytan M Stein, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Courtney D DiNardo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAMoffitt Cancer Center· Tampa, FLMassachusetts General Hospital· Boston, MAMemorial Sloan Kettering· New York, NYMD Anderson Cancer Center· Houston, TX

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