[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castration-resistant-prostate-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castration-resistant-prostate-neoplasms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100605586","phase-3-a-study-of-pasritamig-versus-placebo-in-late-line-metastatic-castration-resistant-prostate-cancer-mcrpc-100605586",false,"NCT07164443","A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)","A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer","KLK2-comPAS","Inclusion Criteria\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m\\^Tc bone scan\n* PSA greater than or equal to (\\>=) 2 nanogram per milliliter (ng\u002FmL) at screening\n* In the opinion of the investigator, the next best treatment option is a clinical trial\n* Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following:\n\nAndrogen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI\n\nTaxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:\n\n1. Cabazitaxel is not available\n2. The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. Participants who cannot continue taxane therapy because of a documented Grade\\>=3 taxane related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment\n\nRadioligand therapy: Should have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:\n\n1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.\n2. The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.\n\nPolyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available\n\n* Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog \\[agonist or antagonist\\]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Participants are eligible if they have the following values:\n\nA) eGFR \\>= 30 milliliters per minute (mL\u002Fmin) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (\\\u003C=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin \\\u003C= 3 times ULN D) Absolute neutrophil count (ANC) \\>= 1.0x10\\^9\u002Fper liter (L) E) Hemoglobin \\>= 8.0 grams per deciliter (g\u002FdL) F) Platelet count \\>= 75x10\\^9\u002FL\n\nExclusion Criteria\n\n* Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade \\\u003C= 2) deep vein thrombosis is not exclusionary\n* Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)\n* Participants with Grade 1 or higher fever (\\>=38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible. Participants must be afebrile (\\\u003C38ºC) at the time of study treatment dosing unless approved by medical monitor\n* Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\\>2 liters per minute (L\u002Fmin) by nasal cannula) to maintain adequate oxygenation\n* Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Any of the following within 6 months prior to first dose of study treatment:\n\nA) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident\n\n\\- Prior treatment with any CD3-directed therapy","MALE","18 Years",{"count":20,"type":21},663,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in combination with best supportive care (BSC) as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).",[27],"Metastatic Castration-resistant Prostate Neoplasms","RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-05","ACTUAL",{"date":34,"type":32},"2025-09-02",{"date":36,"type":21},"2027-12-29",{"name":38,"class":39},"Janssen Research & Development, LLC","INDUSTRY",168,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100502163","phase-1-a-study-of-pasritamig-jnj-78278343-in-combination-with-other-agents-for-metastatic-prostate-cancer-100502163","NCT05818683","A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer","A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \\[AAP\\], lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \\[ng\\]\u002Fmilliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (\\>) 0.2 ng\u002FmL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone)\n* Measurable or evaluable disease, except for Part 2H\n* (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G, 2G (AAP), and Part 1K \\& 2K (JNJ-101556143)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant may have received up to 6 cycles of docetaxel. The last dose of docetaxel must be administered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I \\& 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant must not have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT) for mCRPC\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ functions\n\nExclusion Criteria:\n\n* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications\n* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (\\\u003C=) 1 or baseline levels (except for alopecia, vitiligo, Grade \\\u003C=2 peripheral neuropathy)\n* Solid organ or bone marrow transplantation\n* Known allergies, or intolerance to any of the components (example, excipients) of pasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotide tetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K \\& 2K)\n* Significant infections or serious lung, heart or other medical conditions",{"count":49,"type":21},300,[51],"PHASE1","The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).",[27,54],"Metastatic Hormone-sensitive Prostate Cancer",{"date":31,"type":32},{"date":57,"type":32},"2023-04-26",{"date":59,"type":21},"2028-05-23",{"name":38,"class":39},15]