protocolSection identificationModule nctId: NCT06267729, orgStudyIdInfo id: D9660C00001, briefTitle: Study of AZD0754 in Participants With Metastatic Prostate Cancer, acronym: APOLLO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2027-05-24, completionDateStruct date: 2027-05-24, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer., conditionsModule conditions: Metastatic Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open-Label, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: AZD0754, outcomesModule primaryOutcomes measure: Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)., primaryOutcomes measure: Presence of replication-competent lentivirus (RCL) in peripheral blood samples, secondaryOutcomes measure: Prostate-specific antigen (PSA) response rate - PSA50, secondaryOutcomes measure: PSA response rate - PSA90, secondaryOutcomes measure: Duration of PSA Response (DoPSA50, DoPSA90), secondaryOutcomes measure: Durable PSA Response Rate (DRRPSA50, DRRPSA90), secondaryOutcomes measure: Time to PSA Response (TTPSA50, TTPSA90), secondaryOutcomes measure: Time to PSA Progression (TTPSAP50, TTPSAP90), secondaryOutcomes measure: Best Overall Response (BOR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Durable Response Rate (DRR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Percentage change in tumor size, secondaryOutcomes measure: Radiographic Progression-free Survival (rPFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time from AZD0754 Infusion to the first Symptomatic Skeletal-related Events (SSRE), secondaryOutcomes measure: Pharmacokinetics - maximum observed serum concentration (Cmax) of AZD0754, secondaryOutcomes measure: Pharmacokinetics - time taken to reach maximum serum concentration (Tmax) of AZD0754, secondaryOutcomes measure: Pharmacokinetics - Last measurable serum concentration (Clast) of AZD0754, secondaryOutcomes measure: Pharmacokinetics - time of last measurable serum concentration (Tlast) of AZD0754, secondaryOutcomes measure: Pharmacokinetics - Exposure of AZD0754, secondaryOutcomes measure: Biomarker - STEAP2 expression in Tumor, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Research Site, status: RECRUITING, city: Hackensack, state: New Jersey, zip: 07601, country: United States, geoPoint lat: 40.88593, lon: -74.04347, locations facility: Research Site, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Research Site, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, status: RECRUITING, city: East Melbourne, zip: 3002, country: Australia, geoPoint lat: -37.81667, lon: 144.9879, hasResults: False