protocolSection identificationModule nctId: NCT06353997, orgStudyIdInfo id: 2024000099, briefTitle: Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Providence Health & Services, class: OTHER, collaborators name: Inhibrx, Inc., descriptionModule briefSummary: This is a Phase II trial to assess feasibility of pembrolizumab + INBRX-106 as a chemotherapy-sparing neoadjuvant therapy. One therapeutic arm is being evaluated to provide an informal comparison of pharmacodynamic and clinical effects of concurrent dosing schedule., conditionsModule conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: INBRX-106, outcomesModule primaryOutcomes measure: Pathological response (post-IO), secondaryOutcomes measure: Pathological response (post-chemotherapy), secondaryOutcomes measure: IO-path response assessed prior to Cycle 2, secondaryOutcomes measure: Volumetric response, secondaryOutcomes measure: Event free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Toxicity profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ellison Institute of Technology (EITM), city: Los Angeles, state: California, zip: 90064, country: United States, contacts name: Reva Basho, MD, role: CONTACT, phone: 310-272-7640, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Providence Portland Cancer Institute - Franz Clinic, city: Portland, state: Oregon, zip: 97213, country: United States, contacts name: Nicole Moxon, RN, role: CONTACT, email: canrsrchstudies@providence.org, contacts name: Alison Conlin, MD, role: SUB_INVESTIGATOR, contacts name: Evelyn Brosnan, MD, role: SUB_INVESTIGATOR, contacts name: Evie Hobbs, MD, role: SUB_INVESTIGATOR, contacts name: Rui Li, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Sasha Stanton, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Zheng Topp, MD, role: SUB_INVESTIGATOR, contacts name: Amy Hartman, NP, role: SUB_INVESTIGATOR, contacts name: Kathleen Dronkowski, NP, role: SUB_INVESTIGATOR, contacts name: Kimberlie Dame, NP, role: SUB_INVESTIGATOR, contacts name: Molly Davis, NP, role: SUB_INVESTIGATOR, contacts name: RaYoung Chung, NP, role: SUB_INVESTIGATOR, contacts name: Roxanne Griswold, NP, role: SUB_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Providence St. Vincent Medical Center, city: Portland, state: Oregon, zip: 97225, country: United States, contacts name: Nicole Moxon, RN, role: CONTACT, email: canrsrchstudies@providence.org, contacts name: David Page, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Swedish Cancer Institute, city: Seattle, state: Washington, zip: 98104, country: United States, contacts name: Danielle File, MD, role: CONTACT, phone: 206-386-3900, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False