protocolSection identificationModule nctId: NCT06305247, orgStudyIdInfo id: CLIN-01194-450, secondaryIdInfos id: 2023-506228-10-00, type: OTHER, domain: Ipsen, briefTitle: A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2028-03-20, completionDateStruct date: 2028-03-20, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ipsen, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.In this study, all participants will receive the study drug, which will be taken by mouth (orally)., conditionsModule conditions: Melanoma, conditions: Head and Neck Squamous Cell Carcinoma, conditions: Pancreatic Ductal Adenocarcinoma, conditions: Colorectal Cancer, conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Phase I is a dose escalation with backfill in participants with selected MAPKm advanced solid tumours.Phase IIa (cohort expansion) is an open label randomised study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: IPN01194, interventions name: IPN01194, outcomesModule primaryOutcomes measure: Phase 1: Percentage of participants with dose limiting toxicity (DLT), primaryOutcomes measure: Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs), primaryOutcomes measure: Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations, primaryOutcomes measure: Phase 2a: Objective response rate (ORR), secondaryOutcomes measure: Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194, secondaryOutcomes measure: Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194, secondaryOutcomes measure: Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194, secondaryOutcomes measure: Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state, secondaryOutcomes measure: Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state, secondaryOutcomes measure: Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state, secondaryOutcomes measure: Phase 1: Prolongation of corrected QT interval (QTc), secondaryOutcomes measure: Phase 1: Objective response rate (ORR), secondaryOutcomes measure: Phase 2a: Duration of response (DoR), secondaryOutcomes measure: Phase 2a: Progression-free survival (PFS), secondaryOutcomes measure: Phase 2a: PFS rate at 4 months, secondaryOutcomes measure: Phase 2a: Disease control rate (DCR), secondaryOutcomes measure: Phase 2a: Percentage of participants with TEAEs and TE SAEs, secondaryOutcomes measure: Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Angeles Clinic and Research Institute - California, status: NOT_YET_RECRUITING, city: Los Angeles, state: California, zip: 90025, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: UC San Diego Health System - La Jolla, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92037, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Yale Cancer Center - New Heaven, status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Sarah Cannon Research Institute (SCRI) - Nashville, status: NOT_YET_RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Virginia Cancer Specialist, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Centre Léon Bérard - Lyon, status: NOT_YET_RECRUITING, city: Lyon, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Paris Saint-Louis, status: NOT_YET_RECRUITING, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut de Cancerologie de l'Ouest (St-Herblain), status: NOT_YET_RECRUITING, city: Saint-Herblain, country: France, geoPoint lat: 47.21765, lon: -1.64841, locations facility: IGR-Villejuif, status: NOT_YET_RECRUITING, city: Villejuif, country: France, geoPoint lat: 48.7939, lon: 2.35992, locations facility: Barcelona - Val D'Hebron, status: NOT_YET_RECRUITING, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Fundacion Jimenez Diaz - Madrid, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: M.D. Anderson Cancer Center Madrid, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False