protocolSection identificationModule nctId: NCT06268574, orgStudyIdInfo id: RIVER-52, briefTitle: Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML, acronym: RIVER-52, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ryvu Therapeutics SA, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients., conditionsModule conditions: Acute Myeloid Leukemia (AML), conditions: High-risk Myelodysplastic Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single Group Assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: RVU120, outcomesModule primaryOutcomes measure: Complete Remission (CR), with and without measurable residual disease (MRD), secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of Adverse Events (Safety and Tolerability), secondaryOutcomes measure: Percentage of participants bridged to hematopoietic stem cell transplantation, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: Maximum Plasma Concentration (Tmax), secondaryOutcomes measure: Area Under the Concentration Time-Curve (AUC), secondaryOutcomes measure: Impact of treatment on hematological malignancy patient-reported outcomes (HM-PRO), secondaryOutcomes measure: Impact of treatment on health-related quality of life (QOL-E), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MTZ Clinical Research, status: RECRUITING, city: Warszawa, state: Mazowieckie Województwo, zip: 02-172, country: Poland, contacts name: Krzysztof Mądry, role: CONTACT, phone: +48 22 572 59 59, email: info@pratia.com, contacts name: Krzysztof Mądry, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, locations facility: MICS Centrum Medyczne Toruń, status: RECRUITING, city: Toruń, zip: 87-100, country: Poland, contacts name: Dominik Chraniuk, role: CONTACT, phone: +48 56 300 43, email: d.chraniuk@naszlekarz.pl, contacts name: Dominik Chraniuk, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.01375, lon: 18.59814, hasResults: False