protocolSection identificationModule nctId: NCT06302426, orgStudyIdInfo id: INI-4001-101, briefTitle: Trial of INI-4001 in Patients With Advanced Solid Tumours, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Inimmune Corporation, class: INDUSTRY, collaborators name: Avance Clinical Pty Ltd., descriptionModule briefSummary: Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a Phase Ia/Ib, open-label, dose-escalation and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: INI-4001, interventions name: Nivolumab, interventions name: Pembrolizumab, interventions name: Cemiplimab, interventions name: Avelumab, interventions name: Atezolizumab, interventions name: Durvalumab, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy, secondaryOutcomes measure: Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses, secondaryOutcomes measure: Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in body weight after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses, secondaryOutcomes measure: Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of HR in beats per minute after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses, secondaryOutcomes measure: Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses, secondaryOutcomes measure: Single dose PK Parameters - maximum observed concentration (Cmax), secondaryOutcomes measure: Multiple dose PK Parameters - maximum observed concentration (Cmax), secondaryOutcomes measure: Single dose PK Parameters - Time to Cmax (Tmax), secondaryOutcomes measure: Multiple dose PK Parameters - Time to Cmax (Tmax), secondaryOutcomes measure: Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), secondaryOutcomes measure: Single dose PK Parameters - Total amount excreted in urine (Ae), secondaryOutcomes measure: Single dose PK Parameters - Fraction excreted in the urine (Fe), secondaryOutcomes measure: Single dose PK Parameters - Renal clearance (CLr), secondaryOutcomes measure: Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), secondaryOutcomes measure: Single dose PK Parameters - Area under the concentration-time curve (AUC0-t), secondaryOutcomes measure: Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t), secondaryOutcomes measure: Single dose PK Parameters - Half-life (t1/2), secondaryOutcomes measure: Multiple dose PK Parameters - Half-life (t1/2), secondaryOutcomes measure: Single dose PK Parameters - Clearance (Cl), secondaryOutcomes measure: Multiple dose PK Parameters - Clearance (Cl), secondaryOutcomes measure: Single dose PK Parameters - Volume of distribution (Vz), secondaryOutcomes measure: Multiple dose PK Parameters - Volume of distribution (Vz), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Border Cancer Hospital, city: Albury, state: New South Wales, zip: 2640, country: Australia, contacts name: Reenu Arora, role: CONTACT, email: AroraReenu@ramsayhealth.com.au, contacts name: Kay Xu, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -36.07482, lon: 146.92401, locations facility: Cabrini Hospital, city: Malvern, state: Victoria, zip: 3144, country: Australia, contacts name: Prachi Bhave, role: CONTACT, email: PBhave@cabrini.com.au, contacts name: Prachi Bhave, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.02849, lon: 151.32225, hasResults: False