protocolSection identificationModule nctId: NCT06297941, orgStudyIdInfo id: REM-422-102, briefTitle: Study of REM-422 in Patients With AML or Higher Risk MDS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2027-06-15, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Remix Therapeutics, class: INDUSTRY, descriptionModule briefSummary: 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, conditionsModule conditions: Myelodysplastic Syndromes, conditions: Higher Risk Myelodysplastic Syndromes, conditions: Acute Myeloid Leukemia, conditions: Acute Myeloid Leukemia Refractory, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: REM-422, outcomesModule primaryOutcomes measure: Frequency and severity of Treatment Emergent Adverse Events (TEAEs), primaryOutcomes measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), secondaryOutcomes measure: AML: Rate of Complete Response (remission) (CR), secondaryOutcomes measure: AML: Rate of CR with partial hematologic recovery (CRh), secondaryOutcomes measure: AML: Duration of CR, secondaryOutcomes measure: AML: Duration of CRh, secondaryOutcomes measure: AML: Overall response rate (ORR) (CR + CRh + CRi + PR) with incomplete hematologic recovery [CRi] + partial response [PR]) per modified IWG response criteria 2003 based on Investigator assessment, secondaryOutcomes measure: AML: Duration of response (DOR), secondaryOutcomes measure: MDS: Rate of Compete Response (CR), secondaryOutcomes measure: MDS: Duration of Complete Response (CR), secondaryOutcomes measure: MDS: Overall Response Rate (ORR), secondaryOutcomes measure: MDS: Duration of Response (DOR), secondaryOutcomes measure: Determine pharmacokinetic profile (Cmax) of REM-422, secondaryOutcomes measure: Determine pharmacokinetic profile (Cmin) of REM-422, secondaryOutcomes measure: Determine pharmacokinetic profile (Tmax) of REM-422, secondaryOutcomes measure: Determine pharmacokinetic profile (AUC) of REM-422, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Anthony S Stein, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Memorial Sloan Kettering, city: New York, state: New York, zip: 10065, country: United States, contacts name: Eytan M Stein, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Courtney D DiNardo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False