[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610392":3},{"organization":4,"outcomesModule":7,"designInfo":95,"detailedDescription":101,"studyPopulation":94,"armGroups":102,"interventions":131,"overallOfficials":154,"centralContacts":158,"locations":165,"responsibleParty":397,"collaborators":94,"id":399,"slug":400,"hasResults":401,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":94,"eligibilityCriteria":405,"healthyVolunteers":401,"sex":406,"minAge":407,"maxAge":94,"enrollmentInfo":408,"targetDuration":94,"studyType":411,"phases":412,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":168,"whyStopped":94,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":432},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":94},[9,13,17,21,24,27],{"measure":10,"description":11,"timeFrame":12},"Phase Ib: Incidence rate of Dose-limiting toxicities (DLTs)","Incidence of dose limiting toxicities (DLTs) with AMO959 in combination with AAA617 +\u002F- ARPI A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness\u002Finjury, or concomitant medications that occurs within the evaluation period and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading.","Up to 42 days after the first AAA617 dose administration",{"measure":14,"description":15,"timeFrame":16},"Phase Ib: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)","Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.","From date of start of study treatment, assessed up to approximately 45 months",{"measure":18,"description":19,"timeFrame":20},"Phase Ib: Number of Participants with dose adjustments","The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation).","From date of start of study treatment, assessed up to approximately 24 months",{"measure":22,"description":23,"timeFrame":20},"Phase Ib: Dose Intensity","Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity).",{"measure":25,"description":26,"timeFrame":20},"Phase Ib: Duration of exposure to each study drug","Duration of exposure (in months) to each study drug.",{"measure":28,"description":29,"timeFrame":20},"Phase II: Biochemical Response (PSA50)","Biochemical response (PSA50), defined as the proportion of participants who achieved a ≥ 50% decrease in PSA from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥ 4 weeks later.",[31,34,37,41,44,47,50,54,58,62,66,69,72,74,76,78,80,83,87,90],{"measure":32,"description":33,"timeFrame":20},"Prostate Specific Antigen 90 (PSA90) response","PSA90 response is defined as the proportion of participants who have achieved a ≥ 90% decrease in PSA from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥4 weeks later.",{"measure":35,"description":36,"timeFrame":20},"Phase Ib: Prostate Specific Antigen 50 (PSA50) response","PSA50 response is defined as the proportion of participants who have achieved a ≥ 50% decrease in PSA from baseline at any time during the treatment period prior to the start of new anti-cancer therapy, confirmed by a second PSA measurement ≥4 weeks later.",{"measure":38,"description":39,"timeFrame":40},"Phase Ib and Phase II: Radiographic progression-free survival (rPFS)","Radiographic progression- free survival (rPFS) is defined as the time from the date of start of study treatment (Phase Ib) \u002F randomization (Phase II) to the date of first documented radiographic disease progression using conventional imaging and Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 criteria (Scher et al 2016) or death due to any cause, whichever occurs first.","From date of start of study treatment (Phase Ib) \u002F randomization (Phase II), assessed up to approximately 24 months",{"measure":42,"description":43,"timeFrame":40},"Phase Ib and Phase II: Overall Response Rate (ORR)","Overall Response Rate (ORR) is defined as the proportion of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) in soft tissue based on tumor response data and according to PCWG3-modified RECIST v1.1, in the absence of bone progression as per PCWG3.",{"measure":45,"description":46,"timeFrame":40},"Phase Ib and Phase II: Disease control rate (DCR)","Disease control rate (DCR) is defined as the proportion of participants with a BOR of confirmed CR or PR, stable disease (SD) or Non-CR\u002FNon- progressive disease (PD) in soft tissue based on tumor response data and according to PCWG3-modified RECIST v1.1, in the absence of bone progression as per PCWG3.",{"measure":48,"description":49,"timeFrame":40},"Phase Ib and Phase II: Duration of Response (DoR)","Duration of Response (DoR) is defined as the duration of time between the date of first documented response (CR or PR) according to PCWG3- modified RECIST v1.1, in the absence of bone progression as per PCWG3, based on tumor response data and the date of first documented radiographic progression in soft tissue or death due to any cause, whichever occurs first.",{"measure":51,"description":52,"timeFrame":53},"Overall Survival (OS)","Overall Survival (OS) is defined as the time from the date of start of study treatment (Phase Ib) \u002F randomization (Phase II) to the date of death due to any cause.","From date of start of study, assessed up to approximately 45 months",{"measure":55,"description":56,"timeFrame":57},"Phase II: Time to soft tissue progression (TTSTP)","Time to soft tissue progression (TTSTP) is defined as time from randomization to the date of first documented radiographic soft tissue progression per PCWG3-modified RECIST v1.1.","From date of start of study randomization, assessed up to approximately 24 months",{"measure":59,"description":60,"timeFrame":61},"Phase Ib: Plasma concentrations of AMO959","AMO959 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms","Throughout run-in periods and first cycle with AAA617, assessed up to 6 months",{"measure":63,"description":64,"timeFrame":65},"Phase Ib: Plasma concentrations of AAA617","AAA617 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms","Throughout treatment periods with AAA617, assessed up to 6 months",{"measure":67,"description":68,"timeFrame":65},"Phase Ib: Time activity curves (TACs) for AAA617","Time Activity Curves (TAC) will be generated by plotting concentrations against time.",{"measure":70,"description":71,"timeFrame":65},"Phase Ib: Absorbed radiation doses in selected organs and tumor lesions for AAA617","The organ absorbed radiation dose and effective radiation dose will be evaluated.",{"measure":73,"description":15,"timeFrame":16},"Phase II: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)",{"measure":75,"description":19,"timeFrame":20},"Phase II: Number of Participants with dose adjustments",{"measure":77,"description":23,"timeFrame":20},"Phase II: Dose Intensity",{"measure":79,"description":26,"timeFrame":20},"Phase II: Duration of exposure to each study drug",{"measure":81,"description":82,"timeFrame":57},"Phase II: Radiographic Progression Free Survival (rPFS) by Positron Emission Tomography (PET) (rPFS-PET)","Radiographic Progression Free Survival (rPFS) by Positron Emission Tomography (PET) (rPFS- PET) is defined as the time from the date of randomization to first documented radiographic disease progression (an increase in PSMA-positive tumor volume ≥ 20% from baseline and new PSMA-positive malignant lesions) using PSMA PET\u002FCT imaging (Seifert et al 2023, Gafita et al 2023) or death due to any cause, whichever occurs first.",{"measure":84,"description":85,"timeFrame":86},"Phase II: Change from baseline in FACT-P Prostate Cancer Subscale (PCS)","Change from baseline in FACT-P PCS refers to the difference in a patient's score on the Prostate Cancer Subscale (PCS) of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire between the start of a study (baseline) and subsequent time points.","From date of start of study, assessed up to approximately 45 months.",{"measure":88,"description":89,"timeFrame":86},"Phase II: Time to worsening on the Brief Pain Inventory - Short Form (BPI-SF)","Time to worsening on the Worst Pain defined as the time from the date of randomization to the first occurrence of worsening on the Brief Pain Inventory - Short Form (BPI-SF) Worst Pain item of at least 30% increase from baseline or a minimum of 2 points increase from baseline or death due to any cause, whichever occurs first.",{"measure":91,"description":92,"timeFrame":93},"Phase II: Time to first symptomatic skeletal event (TTSSE)","Time to first symptomatic skeletal event (TTSSE) is defined as the time from the date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, or requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurs first.","From date of start of study randomization, assessed up to approximately 24 months.",null,{"allocation":96,"interventionModel":97,"interventionModelDescription":94,"primaryPurpose":98,"observationalModel":94,"timePerspective":94,"maskingInfo":99},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":100,"maskingDescription":94,"whoMasked":94},"NONE","This study will consist of two phases:\n\n1. The escalation phase (Ib) will consist of provisionally three dose level cohorts of 3-6 participants investigating the safety, tolerability, and to determine the recommended dose for expansion (RDE) of AMO959 with standard dose of AAA617 +\u002F- ARPI (abiraterone or enzalutamide). Initially AMO959 monotherapy will be administered, and then AMO959 will be given along with AAA617 in the same participants. Dose escalation meetings (DEMs) will occur when all participants in a dose level cohort have completed the DLT evaluation period or have experienced a DLT prior to the end of the evaluation period.\n2. The Phase II will follow with 25 participants per arm randomized in a 1:1:1 ratio treated at the RDE(s) of AMO959 along with AAA617 and ARPI (abiraterone or enzalutamide) and AAA617 and ARPI (abiraterone or enzalutamide).",[103,110,116,120,124,127],{"label":104,"type":105,"description":106,"interventionNames":107},"Phase 1b: Doublet","EXPERIMENTAL","Participants will receive AMO959 BID for first 14 days followed by AAA617+AMO959 every 6 weeks for a maximum of 6 cycles.",[108,109],"Drug: AMO959","Radiation: AAA617",{"label":111,"type":105,"description":112,"interventionNames":113},"Phase 1b: Triplet","Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI (abiraterone or enzalutamide) administered continuously starting on day 1.",[108,109,114,115],"Drug: Enzalutamide","Drug: Abiraterone",{"label":117,"type":105,"description":118,"interventionNames":119},"Phase 1b: Food Effect","Participants will receive a single dose of AMO959 on Day 1 (fed), followed by 2-day washout, then AMO959 BID (fasted) for 14 days followed by 2-day washout and AAA617+AMO959 (fasted) every 6 weeks for a maximum of 6 cycles.",[108,109],{"label":121,"type":105,"description":122,"interventionNames":123},"Phase II: Arm 1","Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI (abiraterone or enzalutamide administered continuously starting on day 1.",[108,109,114,115],{"label":125,"type":105,"description":112,"interventionNames":126},"Phase II: Arm 2",[108,109,114,115],{"label":128,"type":105,"description":129,"interventionNames":130},"Phase II: Arm 3","Participants will receive AAA617 every 6 weeks for a maximum of 6 cycles, with ARPI (abiraterone or enzalutamide) administered continuously starting on day 1.",[109,114,115],[132,140,147,151],{"type":133,"name":134,"description":135,"armGroupLabels":136,"otherNames":137},"DRUG","AMO959","DNA Damage Response inhibitor",[104,117,111,121,125],[138,139],"BY1298","BY101298",{"type":141,"name":142,"description":143,"armGroupLabels":144,"otherNames":145},"RADIATION","AAA617","PSMA-targeted radiopharmaceutical",[104,117,111,121,125,128],[146],"Pluvicto [177Lu]Lu-PSMA-617",{"type":133,"name":148,"description":149,"armGroupLabels":150,"otherNames":94},"Enzalutamide","Androgen receptor pathway inhibitor",[111,121,125,128],{"type":133,"name":152,"description":149,"armGroupLabels":153,"otherNames":94},"Abiraterone",[111,121,125,128],[155],{"name":156,"affiliation":156,"role":157},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[159,163],{"name":156,"role":160,"phone":161,"phoneExt":94,"email":162},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":156,"role":160,"phone":164,"phoneExt":94,"email":162},"+41613241111",[166,187,203,220,232,240,245,254,264,272,280,288,299,307,315,323,334,343,351,362,373,382,389],{"facility":167,"status":168,"city":169,"state":170,"zip":171,"country":172,"countryCode":173,"cosmosGeoPoint":174,"geoPoint":179,"contacts":180},"VA Greater LA Healthcare System","RECRUITING","Los Angeles","California","90073","United States","US",{"type":175,"coordinates":176},"Point",[177,178],-118.24368,34.05223,{"lat":178,"lon":177},[181,184],{"name":182,"role":160,"phone":94,"phoneExt":94,"email":183},"Samantha Tran","Samantha.Tran@va.gov",{"name":185,"role":186,"phone":94,"phoneExt":94,"email":94},"Matthew Rettig","PRINCIPAL_INVESTIGATOR",{"facility":188,"status":168,"city":189,"state":190,"zip":191,"country":172,"countryCode":173,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Rio Grande Urology","El Paso","Texas","79912",{"type":175,"coordinates":193},[194,195],-106.48693,31.75872,{"lat":195,"lon":194},[198,201],{"name":199,"role":160,"phone":94,"phoneExt":94,"email":200},"Paola Delgado","pdelgado@riograndeurology.com",{"name":202,"role":186,"phone":94,"phoneExt":94,"email":94},"Jameson T Mendel",{"facility":204,"status":168,"city":205,"state":206,"zip":207,"country":172,"countryCode":173,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Utah Intermountain Medical Center","Murray","Utah","84107",{"type":175,"coordinates":209},[210,211],-111.88799,40.66689,{"lat":211,"lon":210},[214,218],{"name":215,"role":160,"phone":216,"phoneExt":94,"email":217},"Preston Mayer","801-507-9333","preston.mayer@imail.org",{"name":219,"role":186,"phone":94,"phoneExt":94,"email":94},"Dustin Boothe",{"facility":221,"status":168,"city":222,"state":223,"zip":224,"country":225,"countryCode":226,"cosmosGeoPoint":227,"geoPoint":231,"contacts":94},"Novartis Investigative Site","Malvern","Victoria","3144","Australia","AU",{"type":175,"coordinates":228},[229,230],145.02811,-37.86259,{"lat":230,"lon":229},{"facility":221,"status":168,"city":233,"state":223,"zip":234,"country":225,"countryCode":226,"cosmosGeoPoint":235,"geoPoint":239,"contacts":94},"Melbourne","3000",{"type":175,"coordinates":236},[237,238],144.96332,-37.814,{"lat":238,"lon":237},{"facility":221,"status":168,"city":233,"state":223,"zip":241,"country":225,"countryCode":226,"cosmosGeoPoint":242,"geoPoint":244,"contacts":94},"3004",{"type":175,"coordinates":243},[237,238],{"lat":238,"lon":237},{"facility":221,"status":168,"city":246,"state":247,"zip":248,"country":225,"countryCode":226,"cosmosGeoPoint":249,"geoPoint":253,"contacts":94},"Murdoch","Western Australia","6150",{"type":175,"coordinates":250},[251,252],115.83757,-32.06987,{"lat":252,"lon":251},{"facility":221,"status":168,"city":255,"state":94,"zip":256,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":94},"Bordeaux","33076","France","FR",{"type":175,"coordinates":260},[261,262],-0.58046,44.84124,{"lat":262,"lon":261},{"facility":221,"status":168,"city":265,"state":94,"zip":266,"country":257,"countryCode":258,"cosmosGeoPoint":267,"geoPoint":271,"contacts":94},"Clermont-Ferrand","63011",{"type":175,"coordinates":268},[269,270],3.08682,45.77969,{"lat":270,"lon":269},{"facility":221,"status":168,"city":273,"state":94,"zip":274,"country":257,"countryCode":258,"cosmosGeoPoint":275,"geoPoint":279,"contacts":94},"Nantes","44093",{"type":175,"coordinates":276},[277,278],-1.55336,47.21725,{"lat":278,"lon":277},{"facility":221,"status":168,"city":281,"state":94,"zip":282,"country":257,"countryCode":258,"cosmosGeoPoint":283,"geoPoint":287,"contacts":94},"Villejuif","94800",{"type":175,"coordinates":284},[285,286],2.35992,48.7939,{"lat":286,"lon":285},{"facility":221,"status":168,"city":289,"state":290,"zip":291,"country":292,"countryCode":293,"cosmosGeoPoint":294,"geoPoint":298,"contacts":94},"Dresden","Saxony","01307","Germany","DE",{"type":175,"coordinates":295},[296,297],13.73832,51.05089,{"lat":297,"lon":296},{"facility":221,"status":168,"city":300,"state":94,"zip":301,"country":292,"countryCode":293,"cosmosGeoPoint":302,"geoPoint":306,"contacts":94},"Essen","45147",{"type":175,"coordinates":303},[304,305],7.01228,51.45657,{"lat":305,"lon":304},{"facility":221,"status":168,"city":308,"state":94,"zip":309,"country":292,"countryCode":293,"cosmosGeoPoint":310,"geoPoint":314,"contacts":94},"München","80377",{"type":175,"coordinates":311},[312,313],13.31243,51.60698,{"lat":313,"lon":312},{"facility":221,"status":168,"city":316,"state":94,"zip":317,"country":292,"countryCode":293,"cosmosGeoPoint":318,"geoPoint":322,"contacts":94},"Stuttgart","70374",{"type":175,"coordinates":319},[320,321],9.17702,48.78232,{"lat":321,"lon":320},{"facility":221,"status":168,"city":324,"state":325,"zip":326,"country":327,"countryCode":328,"cosmosGeoPoint":329,"geoPoint":333,"contacts":94},"Cona","FE","44124","Italy","IT",{"type":175,"coordinates":330},[331,332],11.7069,44.80583,{"lat":332,"lon":331},{"facility":221,"status":168,"city":335,"state":336,"zip":337,"country":327,"countryCode":328,"cosmosGeoPoint":338,"geoPoint":342,"contacts":94},"Milan","MI","20133",{"type":175,"coordinates":339},[340,341],12.59836,42.78235,{"lat":341,"lon":340},{"facility":221,"status":168,"city":344,"state":94,"zip":345,"country":327,"countryCode":328,"cosmosGeoPoint":346,"geoPoint":350,"contacts":94},"Naples","80131",{"type":175,"coordinates":347},[348,349],14.26811,40.85216,{"lat":349,"lon":348},{"facility":221,"status":168,"city":352,"state":353,"zip":354,"country":355,"countryCode":356,"cosmosGeoPoint":357,"geoPoint":361,"contacts":94},"Sapporo","Hokkaido","0608648","Japan","JP",{"type":175,"coordinates":358},[359,360],141.35,43.06667,{"lat":360,"lon":359},{"facility":221,"status":168,"city":363,"state":364,"zip":365,"country":366,"countryCode":367,"cosmosGeoPoint":368,"geoPoint":372,"contacts":94},"Granada","Andalusia","18014","Spain","ES",{"type":175,"coordinates":369},[370,371],-3.60667,37.18817,{"lat":371,"lon":370},{"facility":221,"status":168,"city":374,"state":375,"zip":376,"country":366,"countryCode":367,"cosmosGeoPoint":377,"geoPoint":381,"contacts":94},"L'Hospitalet de Llobregat","Barcelona","08907",{"type":175,"coordinates":378},[379,380],2.10028,41.35967,{"lat":380,"lon":379},{"facility":221,"status":168,"city":375,"state":94,"zip":383,"country":366,"countryCode":367,"cosmosGeoPoint":384,"geoPoint":388,"contacts":94},"08036",{"type":175,"coordinates":385},[386,387],2.15899,41.38879,{"lat":387,"lon":386},{"facility":221,"status":168,"city":390,"state":94,"zip":391,"country":366,"countryCode":367,"cosmosGeoPoint":392,"geoPoint":396,"contacts":94},"Madrid","28041",{"type":175,"coordinates":393},[394,395],-3.70256,40.4165,{"lat":395,"lon":394},{"type":398,"investigatorFullName":94,"investigatorTitle":94,"investigatorAffiliation":94,"oldNameTitle":94,"oldOrganization":94},"SPONSOR","100610392","phase-1-a-phase-ibii-open-label-study-of-amo959-with-lutetium-177lu-vipivotide-tetraxetan-aaa617-in-combination-with-arpi-in-adult-participants-with-psma-positive-mcrpc-100610392",false,"NCT07226986","A Phase Ib\u002FII Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC","A Phase Ib\u002FII Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have histologically confirmed adenocarcinoma of the prostate. Participants with other histology (e.g. neuroendocrine, intraductal subtype) are not eligible.\n* Phase Ib: Prior exposure of up to 1 line of taxane-based chemotherapy is permissible. Phase II: Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).\n* Participants must have PSMA-PET positive disease assessed by using a PSMA imaging agent that is approved as per protocol and are eligible as determined by the sponsor's central reading rules.\n* Castration level of testosterone (\\\u003C 50 ng\u002FdL), and\u002For use of concomitant ADT\n* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI), based on at least 1 of the following criteria:\n\n  * Serum\u002Fplasma PSA progression is defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng\u002FmL; 1.0 ng\u002FmL is the minimal starting value if confirmed rise in PSA is the only indication of progression as per PCWG3 guidelines.\n  * Soft-tissue progression defined PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016).\n  * Progression of bone disease: 2 new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria Scher et al 2016).\n\nKey Exclusion Criteria:\n\n* Concurrent local (radiation therapy to the prostate with curative intent or other prostate antineoplastic ablative procedures) or systemic (hormonal ablation, chemotherapy, immunotherapy, , RLTs) antineoplastic treatments, or within 28 days of enrollment (Phase Ib) or randomization (Phase II)\n* Prior treatment with any RLT or PSMA-targeted agents (approved or investigational)\n* Any other investigational agents within 28 days prior to first dose of any study treatment\n* Concurrent serious medical conditions that may interfere with study procedures or followup\n* Participants with a history of CNS metastases must have received therapy (surgery, whole brain radiation therapy, stereotactic radiosurgery) and be neurologically stable, asymptomatic, and not taking corticosteroids for the purpose of maintaining neurologic integrity.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE","18 Years",{"count":409,"type":410},123,"ESTIMATED","INTERVENTIONAL",[413,414],"PHASE1","PHASE2","The purpose of this phase Ib\u002FII study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as \\[177Lu\\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.",[417],"PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy",[419,134,420,421,422],"PSMA-positive metastatic castration resistant prostate cancer","Lutetium (177Lu) vipivotide tetraxetan","Androgen Receptor Pathway Inhibitor (ARPI)","dose escalation","2026-10-08",{"date":425,"type":426},"2026-10-09","ACTUAL",{"date":428,"type":426},"2025-12-05",{"date":430,"type":410},"2029-09-13",{"name":156,"class":6},23]