protocolSection identificationModule nctId: NCT06318273, orgStudyIdInfo id: M24-742, briefTitle: A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2027-06-16, completionDateStruct date: 2027-06-17, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy.ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 120 adult participants will be enrolled in the study across sites worldwide.In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans., conditionsModule conditions: Metastatic Castration-Resistant Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ABBV-969, outcomesModule primaryOutcomes measure: Percentage of Participants With Adverse Events (AEs), primaryOutcomes measure: Percentage of Participants Achieving Prostate Specific Antigen (PSA) response, secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-969, secondaryOutcomes measure: Time to Maximum Observed Concentration (Tmax) of ABBV-969, secondaryOutcomes measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-969, secondaryOutcomes measure: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969, secondaryOutcomes measure: Antidrug Antibody (ADA), secondaryOutcomes measure: Neutralizing Antibodies (nAbs), secondaryOutcomes measure: Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope /ID# 262059, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Carolina BioOncology Institute /ID# 261602, status: RECRUITING, city: Huntersville, state: North Carolina, zip: 28078, country: United States, geoPoint lat: 35.41069, lon: -80.84285, locations facility: NEXT Oncology /ID# 261601, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False