protocolSection identificationModule nctId: NCT06362369, orgStudyIdInfo id: 7HP-111, briefTitle: A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: 7 Hills Pharma, LLC, class: INDUSTRY, descriptionModule briefSummary: This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b, conditionsModule conditions: Advanced Cancer, conditions: Advanced Solid Tumor, conditions: Melanoma, conditions: Metastasis, conditions: Pleural Mesothelioma, conditions: Renal Cell Carcinoma, conditions: MSI-High, conditions: Mismatch Repair Deficiency, conditions: Colorectal Cancer, conditions: Hepatocellular Carcinoma, conditions: Hepatocellular Cancer, conditions: Renal Cell Cancer, conditions: Kidney Cancer, conditions: Skin Cancer, conditions: Non Small Cell Lung Cancer, conditions: NSCLC, conditions: Anaplastic Lymphoma Kinase Genomic Tumor Aberrations, conditions: ALK Genomic Tumor Aberrations, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Phase 1b - Open Label, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Alintegimod, interventions name: Ipilimumab, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0, primaryOutcomes measure: Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0, primaryOutcomes measure: Define RPTDs for Alintegimod, secondaryOutcomes measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC), secondaryOutcomes measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC), secondaryOutcomes measure: Determine Progression Free Survival (PFS) response in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 tumor assessment criteria., secondaryOutcomes measure: Determine Overall Response Rate (ORR) in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 response assessment criteria., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florida Cancer Specialists, city: Lake Mary, state: Florida, zip: 32746, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 407-804-6133, contacts name: Alexander Philipovskiy, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.75888, lon: -81.31784, locations facility: Dartmouth Hitchcock, city: Lebanon, state: New Hampshire, zip: 03756, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 603-650-6345, contacts name: Konstantin H Dragnev, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.64229, lon: -72.25176, locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 713-792-4259, contacts name: Apostolia-Maria Tsimberidou, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False