protocolSection identificationModule nctId: NCT06337630, orgStudyIdInfo id: IC 2022-10, briefTitle: A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors, acronym: POP-ART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2029-02-15, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Institut Curie, class: OTHER, collaborators name: ProLynx LLC, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: PLX038 + Tuvusertib, outcomesModule primaryOutcomes measure: Dose escalation step : Dose limiting toxicities (DLTs), primaryOutcomes measure: Expansion cohorts : Best tumor response, primaryOutcomes measure: Expansion cohorts : Serious Adverse Events (SAEs), primaryOutcomes measure: Expansion cohorts : Adverse Events (AEs), secondaryOutcomes measure: Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib, secondaryOutcomes measure: Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib, secondaryOutcomes measure: Dose escalation step : objective response rate (ORR), secondaryOutcomes measure: Dose escalation step : Time to response (TTR), secondaryOutcomes measure: Dose escalation step : Duration of Response (DoR), secondaryOutcomes measure: Dose escalation step : Progression free survival (PFS), secondaryOutcomes measure: Expansion cohorts : Time to response (TTR), secondaryOutcomes measure: Expansion cohorts : Duration of Response (DoR), secondaryOutcomes measure: Expansion cohorts : Progression free survival (PFS), secondaryOutcomes measure: Expansion cohorts : Overall Survival (OS), secondaryOutcomes measure: Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups, secondaryOutcomes measure: Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib, secondaryOutcomes measure: Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib, secondaryOutcomes measure: Exploratory endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut Curie, city: Paris, zip: 75005, country: France, contacts name: François-Clément BIDARD, role: CONTACT, email: francois-clement.bidard@curie.fr, contacts name: François-Clément BIDARD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut Curie, city: Saint-Cloud, zip: 92210, country: France, contacts name: François-Clément BIDARD, role: CONTACT, email: francois-clement.bidard@curie.fr, contacts name: François-Clément BIDARD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.84598, lon: 2.20289, hasResults: False