protocolSection identificationModule nctId: NCT06290388, orgStudyIdInfo id: 23ME-01473-CLIN-001, briefTitle: Study of 23ME-01473 in Patients With Advanced Solid Malignancies, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: 23andMe, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: 23ME-01473, outcomesModule primaryOutcomes measure: Phase 1:Incidence and severity of dose-limiting toxicities (DLTs), primaryOutcomes measure: Phase 1: Incidence and severity of adverse events (AEs), primaryOutcomes measure: Phase 1 Incidence and severity of serious adverse events (SAEs), primaryOutcomes measure: ORR based on investigator assessment against RECIST 1.1 criteria, secondaryOutcomes measure: Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473, secondaryOutcomes measure: Phase 1: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473, secondaryOutcomes measure: Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473, secondaryOutcomes measure: Last measurable serum concentration (Clast) following a single dose of 23ME-01473, secondaryOutcomes measure: Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473, secondaryOutcomes measure: Terminal half-life (T1/2) following a single dose of 23ME-01473, secondaryOutcomes measure: Maximum serum concentration (Cmax) following multiple doses of 23ME-01473, secondaryOutcomes measure: Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473, secondaryOutcomes measure: Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-01473, secondaryOutcomes measure: Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473, secondaryOutcomes measure: Terminal half-life (T1/2) following multiple doses of 23ME-01473, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: START Center for Cancer Care, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False