[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610392":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":60,"centralContacts":64,"locations":71,"responsibleParty":290,"collaborators":56,"id":292,"slug":293,"hasResults":294,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":56,"eligibilityCriteria":298,"healthyVolunteers":294,"sex":299,"minAge":300,"maxAge":56,"enrollmentInfo":301,"targetDuration":56,"studyType":304,"phases":305,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":74,"whyStopped":56,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,15,21,25,29,32],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: AMO959","Radiation: AAA617",{"label":16,"type":10,"description":17,"interventionNames":18},"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.",[13,14,19,20],"Drug: Enzalutamide","Drug: Abiraterone",{"label":22,"type":10,"description":23,"interventionNames":24},"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.",[13,14],{"label":26,"type":10,"description":27,"interventionNames":28},"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.",[13,14,19,20],{"label":30,"type":10,"description":17,"interventionNames":31},"Phase II: Arm 2",[13,14,19,20],{"label":33,"type":10,"description":34,"interventionNames":35},"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.",[14,19,20],[37,45,52,57],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","AMO959","DNA Damage Response inhibitor",[9,22,16,26,30],[43,44],"BY1298","BY101298",{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"RADIATION","AAA617","PSMA-targeted radiopharmaceutical",[9,22,16,26,30,33],[51],"Pluvicto [177Lu]Lu-PSMA-617",{"type":38,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Enzalutamide","Androgen receptor pathway 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de Llobregat","Barcelona","08907",{"type":81,"coordinates":271},[272,273],2.10028,41.35967,{"lat":273,"lon":272},{"facility":127,"status":74,"city":268,"state":56,"zip":276,"country":259,"countryCode":260,"cosmosGeoPoint":277,"geoPoint":281,"contacts":56},"08036",{"type":81,"coordinates":278},[279,280],2.15899,41.38879,{"lat":280,"lon":279},{"facility":127,"status":74,"city":283,"state":56,"zip":284,"country":259,"countryCode":260,"cosmosGeoPoint":285,"geoPoint":289,"contacts":56},"Madrid","28041",{"type":81,"coordinates":286},[287,288],-3.70256,40.4165,{"lat":288,"lon":287},{"type":291,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"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":302,"type":303},123,"ESTIMATED","INTERVENTIONAL",[306,307],"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.",[310],"PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy",[312,39,313,314,315],"PSMA-positive metastatic castration resistant prostate cancer","Lutetium (177Lu) vipivotide tetraxetan","Androgen Receptor Pathway Inhibitor (ARPI)","dose escalation","2026-07-01",{"date":318,"type":319},"2026-07-02","ACTUAL",{"date":321,"type":319},"2025-12-05",{"date":323,"type":303},"2029-09-13",{"name":62,"class":6},21]