nctId: NCT06302426 id: INI-4001-101 briefTitle: Trial of INI-4001 in Patients With Advanced Solid Tumours overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2024-08-01 date: 2026-04-30 date: 2024-03-08 date: 2024-03-08 name: Inimmune Corporation class: INDUSTRY name: Avance Clinical Pty Ltd. 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. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 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 masking: NONE count: 50 type: ESTIMATED name: INI-4001 name: Nivolumab name: Pembrolizumab name: Cemiplimab name: Avelumab name: Atezolizumab name: Durvalumab measure: Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy measure: Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses measure: Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses measure: Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses measure: Number of Participants with a Change from baseline in body weight after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses measure: Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses measure: Change from baseline in measurements of HR in beats per minute after multiple ascending doses measure: Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses measure: Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses measure: Single dose PK Parameters - maximum observed concentration (Cmax) measure: Multiple dose PK Parameters - maximum observed concentration (Cmax) measure: Single dose PK Parameters - Time to Cmax (Tmax) measure: Multiple dose PK Parameters - Time to Cmax (Tmax) measure: Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) measure: Single dose PK Parameters - Total amount excreted in urine (Ae) measure: Single dose PK Parameters - Fraction excreted in the urine (Fe) measure: Single dose PK Parameters - Renal clearance (CLr) measure: Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) measure: Single dose PK Parameters - Area under the concentration-time curve (AUC0-t) measure: Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t) measure: Single dose PK Parameters - Half-life (t1/2) measure: Multiple dose PK Parameters - Half-life (t1/2) measure: Single dose PK Parameters - Clearance (Cl) measure: Multiple dose PK Parameters - Clearance (Cl) measure: Single dose PK Parameters - Volume of distribution (Vz) measure: Multiple dose PK Parameters - Volume of distribution (Vz) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Border Cancer Hospital city: Albury state: New South Wales zip: 2640 country: Australia name: Reenu Arora role: CONTACT email: AroraReenu@ramsayhealth.com.au name: Kay Xu, Dr role: PRINCIPAL_INVESTIGATOR lat: -36.07482 lon: 146.92401 facility: Cabrini Hospital city: Malvern state: Victoria zip: 3144 country: Australia name: Prachi Bhave role: CONTACT email: PBhave@cabrini.com.au name: Prachi Bhave, Dr role: PRINCIPAL_INVESTIGATOR lat: -32.02849 lon: 151.32225 hasResults: False