protocolSection identificationModule nctId: NCT06372717, orgStudyIdInfo id: AP30CP01, briefTitle: A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Apollo Therapeutics Ltd, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-4098 alone and/or in combination with azacitidine for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB). Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only., conditionsModule conditions: Acute Myeloid Leukemia Refractory, conditions: Myelodysplastic Syndrome Acute Myeloid Leukemia, conditions: Myelodysplastic Syndrome With Excess Blasts, conditions: Acute Myeloid Leukemia, in Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: APL-4098, interventions name: Azacitidine and APL-4098, outcomesModule primaryOutcomes measure: Incidence of Treatment Emergent Adverse Events [Safety] (Phase 1), primaryOutcomes measure: Incidence of Dose Limiting Toxicities [Tolerability] (Phase 1), primaryOutcomes measure: Estimate the Maximum Tolerated Dose (MTD) of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Determine Recommended Phase 2 Dose (RP2D) levels of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1), primaryOutcomes measure: Assess efficacy of APL-4098 alone and/or in combination with azacitidine (Phase 2), secondaryOutcomes measure: Assess response to disease with APL-4098 alone and/or in combination with azacitidine (Phase 1), secondaryOutcomes measure: Duration of response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2), secondaryOutcomes measure: Time to response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2), secondaryOutcomes measure: Event Free Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2), secondaryOutcomes measure: Overall Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2), secondaryOutcomes measure: Incidence of Treatment Emergent Adverse Events [Further Safety] (Phase 2), secondaryOutcomes measure: Incidence of Adverse Events leading to discontinuation of APL-4098 [Further Tolerability] (Phase 2), secondaryOutcomes measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2), secondaryOutcomes measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2), secondaryOutcomes measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False