protocolSection identificationModule nctId: NCT06320405, orgStudyIdInfo id: STUDY00025940, secondaryIdInfos id: NCI-2024-01397, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00025940, type: OTHER, domain: OHSU Knight Cancer Institute, briefTitle: Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: OHSU Knight Cancer Institute, class: OTHER, collaborators name: Oregon Health and Science University, collaborators name: Incyte Corporation, descriptionModule briefSummary: This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors., conditionsModule conditions: Advanced Malignant Solid Neoplasm, conditions: Metastatic Malignant Solid Neoplasm, conditions: Recurrent Malignant Solid Neoplasm, conditions: Refractory Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Axatilimab, interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: Paclitaxel, interventions name: Positron Emission Tomography, interventions name: Retifanlimab, outcomesModule primaryOutcomes measure: Incidence of dose limiting toxicities (phase Ib), primaryOutcomes measure: Recommended phase 2 dose of the study drug combination (phase Ib), primaryOutcomes measure: Clinical benefit rate (phase Ib/II), secondaryOutcomes measure: Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs, secondaryOutcomes measure: Changes in immune cell composition and functionality, secondaryOutcomes measure: Change in immune cell population, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHSU Knight Cancer Institute, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Shivaani Kummar, role: CONTACT, phone: 503-494-6594, email: kummar@ohsu.edu, contacts name: Shivaani Kummar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False