nctId: NCT06267729 id: D9660C00001 briefTitle: Study of AZD0754 in Participants With Metastatic Prostate Cancer acronym: APOLLO overallStatus: RECRUITING date: 2024-03-12 date: 2027-05-24 date: 2027-05-24 date: 2024-02-20 date: 2024-04-29 name: AstraZeneca class: INDUSTRY 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. conditions: Metastatic Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: Open-Label count: 60 type: ESTIMATED name: AZD0754 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). measure: Presence of replication-competent lentivirus (RCL) in peripheral blood samples measure: Prostate-specific antigen (PSA) response rate - PSA50 measure: PSA response rate - PSA90 measure: Duration of PSA Response (DoPSA50, DoPSA90) measure: Durable PSA Response Rate (DRRPSA50, DRRPSA90) measure: Time to PSA Response (TTPSA50, TTPSA90) measure: Time to PSA Progression (TTPSAP50, TTPSAP90) measure: Best Overall Response (BOR) measure: Objective Response Rate (ORR) measure: Time to Response (TTR) measure: Duration of Response (DoR) measure: Durable Response Rate (DRR) measure: Disease Control Rate (DCR) measure: Percentage change in tumor size measure: Radiographic Progression-free Survival (rPFS) measure: Overall Survival (OS) measure: Time from AZD0754 Infusion to the first Symptomatic Skeletal-related Events (SSRE) measure: Pharmacokinetics - maximum observed serum concentration (Cmax) of AZD0754 measure: Pharmacokinetics - time taken to reach maximum serum concentration (Tmax) of AZD0754 measure: Pharmacokinetics - Last measurable serum concentration (Clast) of AZD0754 measure: Pharmacokinetics - time of last measurable serum concentration (Tlast) of AZD0754 measure: Pharmacokinetics - Exposure of AZD0754 measure: Biomarker - STEAP2 expression in Tumor sex: MALE minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33612 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Research Site status: RECRUITING city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: Research Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: RECRUITING city: East Melbourne zip: 3002 country: Australia lat: -37.81667 lon: 144.9879 hasResults: False