[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castration-resistant-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castration-resistant-prostate-cancer":40},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,62,94,119,170,208,240,267,301,343,375,395,418,443,464,487,515,543,567,594,639,664,702,723,748],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":41,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100643883","docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100643883",false,"NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","ALL","18 Years","120 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[29,30,31,32,33,34,35,36,37,38,39,40],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Prostate Cancer","Metastatic Castration Resistant Prostate Cancer",[42,43,44,45,46,47,48],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor","NOT_YET_RECRUITING","2026-08-20",{"date":52,"type":53},"2026-08-21","ACTUAL",{"date":55,"type":22},"2026-08-26",{"date":57,"type":22},"2037-10-01",{"name":59,"class":60},"National Cancer Institute (NCI)","NIH",1,{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100609368","phase-3-a-study-of-xaluritamig-plus-abiraterone-versus-investigators-choice-in-participants-with-chemotherapy-nave-metastatic-castration-resistant-prostate-cancer-100609368","NCT07213674","A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n* Participant must have histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.\n* Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:\n\n  * Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng\u002FmL.\n  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.\n  * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).\n* Participants must have had prior orchiectomy and\u002For ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL).\n* Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.\n* Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\nDisease Related:\n\n* Participants with a history of central nervous system (CNS) metastases.\n* Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.\n\nPrior\u002FConcomitant Therapy:\n\n* Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Prior disease progression on or intolerance to abiraterone.\n* Prior treatment with any chemotherapy regimen in the mCRPC setting and\u002For \\> 6 cycles of docetaxel treatment in the mHSPC setting.\n* Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:\n\n  * Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.\n  * Androgen suppression therapy (eg, luteinizing hormone-releasing hormone\u002Fgonadotrophin releasing hormone \\[LHRH\u002FGnRH\\] analogue \\[agonist\u002Fantagonist\\]) is permitted.\n* Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.\n* Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.\n* Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.\n* Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.\n* Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.\n* Prior CD3-directed therapy.","MALE",{"count":71,"type":22},750,[73],"PHASE3","The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).",[76],"Metastatic Castration-resistant Prostate Cancer",[39,78,79,80,81,82,83],"Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Xaluritamig","Abiraterone","Abiraterone Acetate","Docetaxel","Cabazitaxel","RECRUITING",{"date":52,"type":53},{"date":87,"type":53},"2025-11-28",{"date":89,"type":22},"2032-08-30",{"name":91,"class":92},"Amgen","INDUSTRY",150,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100593339","phase-2-a-phase-2-study-to-evaluate-the-effects-of-asp5541-in-participants-with-prostate-cancer-100593339","NCT07005154","A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer","A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.\n* Participant has ECOG performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.\n* Participant must have an estimated life expectancy of ≥ 12 months with mHSPC or ≥ 6 months with mCRPC.\n* Participant is able to understand and comply with all study requirements and procedures.\n* Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET).\n* Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1).\n\nNote: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study.\n\n* If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry:\n\n  * Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT\u002FMRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3.\n  * PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng\u002FmL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment.\n* If the participant has mCRPC, participant has a serum testosterone level \\\u003C 1.73 nmol\u002FL (\\\u003C 50 ng\u002FdL) at the Screening visit.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration.\n* Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration.\n* Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study.\n* Participant should have normal serum potassium (within the local laboratory normal range) at screening without supplementation.\n\nExclusion Criteria:\n\n* Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.\n* Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and\u002For radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible.\n* Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type\n  * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years\n  * Any other cancer from which the participant has been disease-free for ≥5 years\n* Participant has clinically significant cardiac disease, defined as any of the following:\n\n  * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.\n  * Congenital long QT syndrome.\n  * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor.\n  * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \\\u003C 50% at baseline.\n  * Cohorts 1 and 3: Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.\n  * Cohort 2: Participants must not have symptomatic heart failure, unstable or new-onset angina or myocardial infarction within the past 12 months.\n  * Cohorts 1 and 3: Uncontrolled hypertension, defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.\n  * Cohort 2: Uncontrolled hypertension, defined as systolic BP \\> 140 mmHg or diastolic BP \\> 90 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. Participants may be receiving a maximum of 2 antihypertensives that were initiated at least 3 months prior to Cycle 1 Day 1.\n  * Cohort 1 and 3: Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \\> 1 month before Cycle 1 Day 1).\n  * Cohort 2: Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within the last 12 months.\n* Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \\> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.\n* Participant has had major surgery (e.g., requiring general anesthesia) within 30 days before screening, or has not fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1.\n* Participant received a blood transfusion within 1 month of the first dose of study intervention.\n* Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).\n* Participant has hemoglobin A1c (HbA1c) \\> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \\> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.)\n* Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA).\n* Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).\n* Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive).\n* Participant has a body mass index \\> 40 kg\u002Fm2.\n* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening.\n* Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted.\n* Participant received treatment with herbal medications with known anti-cancer properties or known effects on prostate physiology within 4 weeks prior to Cycle 1 Day 1 (e.g., saw palmetto, St. John's wort, turmeric\u002Fcurcumin). Participants must agree not to use herbal products during study participation.\n* Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.\n* Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.\n* Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg\u002Fday or less prior to first dose of study drug is eligible for study entry.\n* Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications.\n* For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment:\n\n  * Hormonal therapy (e.g., androgen receptor blockers \\[AR\\] antagonists, second-generation androgen receptor pathway inhibitors \\[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted.\n  * Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer)\n  * Biologic therapy within 4 weeks of C1D1\n  * Immunotherapy within 4 weeks of C1D1\n  * Radiation therapy (includes radioligands) within 4 weeks of C1D1\n* For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):\n\n  * Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens.\n  * Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1.\n  * Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1.\n  * Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1.\n* Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.\n* Participant has received ASP5541 previously.\n* Participant has absolute neutrophil count \\\u003C 1500\u002FμL, platelet count \\\u003C 100000\u002FμL or hemoglobin \\\u003C 9 g\u002FdL (6.2 mmol\u002FL) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening.\n* Participant has serum total bilirubin \\> 1.5 x upper limit of normal (ULN) (or \\> 3 x ULN for participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \\> 2.5 x ULN at Screening.\n* Participant does not have adequate renal function defined as a calculated creatinine clearance \\\u003C 30 mL\u002Fmin as determined by a validated algorithm for calculating creatinine clearance.\n* Participant has serum albumin \\\u003C 3.0 g\u002FdL (30 g\u002FL) at Screening.\n* Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used.\n* Participant has a gastrointestinal disorder affecting absorption.",{"count":102,"type":22},218,[26],"Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body. Androgen receptor pathway inhibitors (ARPIs) are another type of hormone therapy. They either slow down how much testosterone is made or block testosterone from reaching the prostate cancer cells. Abiraterone acetate (AA) is an ARPI that is used to treat advanced prostate cancer. This type of treatment is usually given as a tablet with a steroid called prednisone\u002Fprednisolone to manage any medical problems from the hormone therapy.\n\nASP5541 is a different form of abiraterone acetate. It is given as an injection into the muscle. In this study, ASP5541 will be given to men with advanced prostate cancer, both with and without prednisone\u002Fprednisolone. This study will check the safety of ASP5541 and compare how well ASP5541 works in men with advanced prostate cancer compared to abiraterone acetate.\n\nThe main aims of the study are:\n\n* To check how well ASP5541 with prednisone\u002Fprednisolone works compared to AA with prednisone\u002Fprednisolone in men with advanced prostate cancer who haven't previously been treated with an ARPI.\n* To check the safety of ASP5541 given by itself in men with advanced prostate cancer that haven't previously been treated with an ARPI.\n* To check how well ASP5541 given by itself works compared to AA with prednisone\u002Fprednisolone in men with advanced prostate cancer that haven't previously been treated with an ARPI.\n* To check the safety of ASP5541 with prednisone\u002Fprednisolone in Japanese men with advanced prostate cancer.\n\nAdult men with a certain type of advanced prostate cancer can take part. Their cancer has spread to other parts of the body (metastatic). The different types are:\n\n* Metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer that needs testosterone to grow.\n* Metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer that continues to grow even when testosterone levels are low.\n\nIn this study there will be 3 treatment groups:\n\n* In Group 1, men with mCRPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 and prednisone\u002Fprednisolone or be given abiraterone acetate and prednisone\u002Fprednisolone.\n* In Group 2, men with mHSPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 by itself or be given abiraterone acetate with prednisone\u002Fprednisolone.\n* In Group 3, Japanese men with mCRPC or mHSPC who may or may not have previously been treated with an androgen receptor pathway inhibitor will be given ASP5541 with prednisone\u002Fprednisolone.\n\nASP5541 will be given as an injection into a muscle every 12 weeks. Men with mCRPC will take prednisone\u002Fprednisolone twice daily and men with mHSPC will take prednisone\u002Fprednisolone once daily. Abiraterone acetate will be given as tablets to be taken once daily. All groups will also receive the standard of care treatment, such as androgen deprivation therapy.\n\nThe men in the study will visit their clinic regularly during and after treatment for health checks, including checking for any medical problems. Some men (Group 2) will check their blood pressure weekly at home. On some visits they will also have scans to check for any changes in their cancer. The number of visits and type of safety checks done at each visit will depend on the health of each person and when they completed their treatment.",[39,106,107],"Metastatic Castration-Resistant Prostate Cancer","Metastatic Hormone Sensitive Prostate Cancer",[109,110],"ASP5541","PRL-02",{"date":52,"type":53},{"date":113,"type":53},"2025-08-19",{"date":115,"type":22},"2032-05-31",{"name":117,"class":92},"Astellas Pharma Global Development, Inc.",53,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":138,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100370548","phase-1-a-study-of-tulmimetostat-dzr123-cpi-0209-in-patients-with-advanced-solid-tumors-and-lymphomas-100370548","NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease",{"count":127,"type":22},300,[25,26],"The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[131,132,133,134,135,136,137,76],"Advanced Solid Tumor","Diffuse Large B Cell Lymphoma","Lymphoma, T-Cell","Mesothelioma, Malignant","Prostatic Neoplasms, Castration-Resistant","Endometrial Cancer","Ovarian Clear Cell Carcinoma",[139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,136,137,156,157,158,159],"Tulmimetostat","DZR123","Lymphoma, Large B-Cell, Diffuse","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)","2026-08-18",{"date":162,"type":53},"2026-08-19",{"date":164,"type":53},"2019-09-18",{"date":166,"type":22},"2030-02-27",{"name":168,"class":92},"Novartis Pharmaceuticals",80,{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100574838","phase-3-a-study-to-compare-the-efficacy-and-safety-of-bms-986365-versus-the-investigators-choice-of-therapy-in-participants-with-metastatic-castration-resistant-prostate-cancer-100574838","NCT06764485","A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer","A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge","rechARge","Inclusion Criteria\n\n* Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.\n* Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and\u002For soft tissue lesions on computed tomography\u002Fmagnetic resonance imaging (CT\u002FMRI).\n* Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be \\\u003C 4.\n* Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).\n\nExclusion Criteria\n\n* Participants must not have impaired cardiac function or clinically significant cardiac disease.\n* Participants must not have any brain metastasis.\n* Participants must not have any liver metastasis.\n* Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":179,"type":22},960,[73],"The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.",[76],[184,185,186,187,188,189,190,191,192,193,194,195,196,197,176,80,82,198],"Prostate cancer","Protein degrader","Protein degradation","Androgen receptor","Castrate resistant prostate cancer","Castration resistant prostate cancer","Hormone resistant","Metastatic hormone resistant prostate cancer","Metastatic castrate resistant prostate cancer","Metastatic castration resistant prostate cancer","BMS-986365","CC-94676","CA071-1000","CA0711000","Enzalutamide","2026-08-17",{"date":160,"type":53},{"date":202,"type":53},"2025-03-13",{"date":204,"type":22},"2029-01-19",{"name":206,"class":92},"Celgene",281,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100580837","phase-2-a-study-of-fg-3246-in-participants-with-metastatic-castration-resistant-prostate-cancer-mcrpc-100580837","NCT06842498","A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","A Phase 2 Dose Optimization Trial Evaluating a CD46-Targeted Antibody-Drug Conjugate (FG-3246) in Patients With Metastatic Castration-Resistant Prostate Cancer","Key Inclusion Criteria:\n\n* Participant must have histological, and\u002For cytological confirmation of prostate adenocarcinoma on all prior tumor biopsies.\n* Participant with soft tissue disease and a safely accessible soft tissue tumor lesion(s) must agree to biopsy of a primary or metastatic lesion during screening. Alternatively, participant may provide a suitable archival biopsy of a primary or metastatic lesion.\n* Participant must have serum testosterone levels \\\u003C50 nanograms (ng)\u002Fdeciliter (dL) during screening.\n* Participant is required to have progressed on no more than one prior treatment with a second generation ARSI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide) initiated in either the castration-sensitive or castration-resistant setting.\n* Participant must have progressive mCRPC following last treatment at screening.\n* Participant must have ≥1 metastatic lesion that is present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤28 days prior to randomization.\n* Participant must have adequate organ function during screening.\n\nKey Exclusion Criteria:\n\n* Participant has received previous treatment with a therapeutic targeting CD46.\n* Participant has small cell neuroendocrine carcinoma (pure or mixed) on any prior histologic evaluation of primary or metastatic lesion.\n* Participant has progressed on more than one prior second-generation ARSI in any setting or has received more than two prior second-generation ARSIs in any setting.\n* Participants must not have received recent anticancer treatments before enrollment. Ongoing supportive or hormonal therapies are allowed if they were started well before randomization and are continued without change.\n* Participant has received any prior radiation therapy within 14 days prior to randomization.\n* Participant has a known actionable mutation or gene alteration, for example, BRCA1 mutation, for which approved therapies are available, for example, PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy.\n* Participant has National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2 peripheral neuropathy at the time of screening from any etiology.\n* Participant has received any prior chemotherapy; however, one prior taxane-based chemotherapy in the castration-sensitive setting is allowed if completed \\>12 months before randomization.\n* Participant has known hypersensitivity to the components of FG-3246 or its analogs or a history of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies.\n* Participant has diagnosis with any other malignancy in the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin.\n* Participant requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer drug that cannot be safely discontinued.\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion may apply.",{"count":5,"type":22},[26],"The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.",[106],[220,221,222,223,224,184,225,226,227,228,229,230,231],"FG-3246","FOR46","mCRPC","CRPC","CD46","Antibody-drug conjugate","Metastatic prostate cancer","FibroGen","ADC","Kyntra","Kyntra Bio","KYNB","2026-08-14",{"date":199,"type":53},{"date":235,"type":53},"2026-02-22",{"date":237,"type":22},"2028-03-31",{"name":230,"class":92},23,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":248,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":61},"100572825","phase-2-cabazitaxel---carboplatin-vs-177lu-psma-617-in-metastatic-castrate-resistant-prostate-cancer-100572825","NCT06738303","Cabazitaxel +\u002F- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer","Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)","CATCH-177","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed adenocarcinoma of prostate\n* Evidence of metastatic castrate-resistant prostate cancer that has previously been treated with an androgen receptor pathway inhibitor. Prior docetaxel exposure is recommended but not mandatory. Tissue is not mandatory, but a pathologic report is required at time of enrollment.\n* Patients must have a PSMA-positive 18F-rhPSMA-7.3 performed within 12 weeks from C1D1 with ≥1 site with SUVmax ≥10. An alternative PSMA PET tracer is permitted at baseline if performed within 8 weeks prior to randomization.\n* Eligible patients have evidence of mCRPC who have progressed on prior novel hormonal agent(s) to include at least one of the following:\n\n  * Baseline PSMA SUVmean \\\u003C10 OR\n  * ≥1 visceral metastasis OR\n  * ≥5 bone metastases OR one of the following (using Next Generation Sequencing on file within 5 years)\n  * TP53\n  * PTEN\n  * mutation.\n* Age \\> 18 years.\n* ECOG performance status of 0 to 2.\n* Participants must have adequate organ and marrow function as defined below to be suitable for the randomized treatment outlined in this\n\n  * Absolute neutrophil count \\>1000\u002FμL; platelet count \\>90 000\u002FμL; hemoglobin \\>8.5 g\u002FdL) at screening.\n  * Note: Participants must not have received any growth factors within 7 days or blood transfusions within 14 days prior to the hematologic laboratory values obtained at screening).\n  * Total bilirubin (TBIL) \\\u003C2.5 × the upper limit of normal (ULN) at screening, except participants with documented Gilbert syndrome who must have a TBIL \\\u003C3 mg\u002FdL\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 5 ULN at screening\n  * Creatinine clearance ≥40 mL\u002Fmin and\u002For estimated glomerular filtration rate (eGFR) ≥30\n  * Albumin \\>30 g\u002FL (3.0 g\u002FdL) at screening\n* Participants receiving bisphosphonates or other approved bone-targeting therapy (e.g., denosumab) must be on a stable dose for at least 14 days before the start of study treatment.\n* Participants of child-producing potential agree to use highly effective contraceptive methods (i.e., barrier contraception measures such as a male condom with spermicide during intercourse) and avoid sperm donation during the study treatment and for 3 months after the last dose of study treatment. A man is considered to be of child-producing potential, unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. Partners of patients must also practice approved forms of birth control\n* Participants must have the ability to understand and the willingness to sign a written informed consent form (ICF).\n* Members of all races and ethnic groups are eligible for this trial\n\nExclusion Criteria:\n\n* Evidence of hormone-sensitive prostate cancer (HSPC)\n* Evidence of small cell prostate cancer\n* Participants receiving any other investigational agents.\n* Diagnosis of another clinically significant malignancy within the previous 2 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or noninvasive malignancies, as determined by the PI or Co-PI.\n* Participants with brain metastases\u002Fcentral nervous system (CNS) disease that are treated prior to enrollment will be allowed in this clinical trial.\n* Known or suspected significant hypersensitivity to any components of the formulation used for Cabazitaxel, carboplatin or 177Lu-PSMA-617.\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations considered by the Investigator to limit compliance with study requirements.\n* Prior treatment toxicities not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0","19 Years",{"count":250,"type":22},44,[26],"The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.",[254,76],"Metastatic Prostate Cancer",[83,256,257],"Lu-PSMA-617","Carboplatin","2026-08-13",{"date":232,"type":53},{"date":261,"type":53},"2025-07-14",{"date":263,"type":22},"2026-12",{"name":265,"class":266},"Case Comprehensive Cancer Center","OTHER",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":23,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":300},"100564484","phase-3-a-study-to-learn-how-pf-06821497-mevrometostat-works-in-men-with-metastatic-castration-resistant-prostate-cancer-100564484","NCT06629779","A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.","A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.\n* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT\u002FMRI scan.\n* Progressive disease in the setting of medical or surgical castration.\n* ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.\n* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.\n* Clinically significant cardiovascular disease.\n* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.\n* Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.\n* Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4\u002F6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:\n\n  1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;\n  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.\n* Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).\n* Inadequate organ function.",{"count":275,"type":22},900,[73],"This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.",[106],[280,281,282,283,284,285,222,286,287,288,289,290,291,292],"MEVROMETOSTAT","METASTATIC CASTRATION RESISTANT PROSTATE CANCER","PF-06821497","EZH2","enhancer of zeste homologue-2","enzalutamide","Prostrate Cancer","castrate resistant prostate cancer","prostatecancer-study.com","efficacy","safety","pharmacokinetics","pharmacodynamics",{"date":232,"type":53},{"date":295,"type":53},"2024-10-22",{"date":297,"type":22},"2028-11-30",{"name":299,"class":92},"Pfizer",236,{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":326,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"100509886","phase-1-fog-001-in-locally-advanced-or-metastatic-solid-tumors-100509886","NCT05919264","FOG-001 in Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and marrow function.\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs).\n\nAdditional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):\n\n* Diagnosis of treatment-refractory advanced\u002Fmetastatic non-MSI-H or non-dMMR CRC.\n* At least one lesion that is suitable for a core needle biopsy.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):\n\n* Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):\n\n* Desmoid tumor (aggressive fibromatosis)\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n* One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed.\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab\n\n* Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.\n* MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1\u002FPD-L1\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible\n\nAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine\u002FTipiracil + Bevacizumab\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n* Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.\n\nMonotherapy Dose Optimization (Part 1i): FAP\n\n* Diagnosis of phenotypic classical FAP with a documented APC mutation\n* Post-colectomy \\>6 months prior to first dose of study drug administration with measurable duodenal polyp burden\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2a):\n\n* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC\n\nAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2b):\n\n* Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence\n\nExclusion Criteria:\n\n* Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC. For participants with FAP, osteomas are allowed.\n* Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.\n* Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.\n* Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)\n* Unstable\u002Finadequate cardiac function.\n* Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.\n* Pregnant, lactating, or planning to become pregnant.\n* Complete colectomy within 6 months of the first dose of study drug administration.",{"count":309,"type":22},619,[25,26],"The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).",[313,314,315,316,317,318,319,320,321,76,322,323,39,324,325],"Cancer","Colorectal Cancer","Solid Tumor","Locally Advanced Solid Tumor","Metastatic Cancer","WNT Pathway","HCC","Desmoid","Microsatellite Stable Colorectal Cancer","Familial Adenomatous Polyposis (FAP)","Endometrial Carcinoma","Microsatellite Instability-High Colorectal Cancer","Adamantinomatous Craniopharyngioma",[313,315,316,317,327,328,329,320,330,331,332,333,334],"WNT Pathway Activating Mutation (WPAM)","Colorectal Cancer (CRC)","Microsatellite Stable (MSS)","Hepatocellular Carcinoma (HCC)","Adenomatous Polyposis Coli (APC)","β-catenin","Beta-catenin","CTNNB1",{"date":199,"type":53},{"date":337,"type":53},"2023-05-23",{"date":339,"type":22},"2027-08-31",{"name":341,"class":92},"Parabilis Medicines, Inc.",33,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":360,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100476843","phase-2-study-of-dato-dxd-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-patients-with-advanced-solid-tumours-tropion-pantumor03-100476843","NCT05489211","Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced\u002FMetastatic Solid Tumours","Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP\n\n* Male and female, ≥ 18 years\n* Documented advanced or metastatic malignancy\n* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing\n* All participants must provide a tumour sample for tissue-based analysis\n* At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease\n* Adequate bone marrow reserve and organ function\n* Minimum life expectancy of 12 weeks\n* At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* All women of childbearing potential must have a negative serum pregnancy test documented during screening\n* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.\n* Capable of giving signed informed consent\n* Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol\n* History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent\n* Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved\n* Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss\n* Spinal cord compression or brain metastases unless treated\n* Leptomeningeal carcinomatosis\n* Clinically significant corneal disease\n* Active hepatitis or uncontrolled hepatitis B or C virus infection\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms\n* Known HIV infection that is not well controlled\n* Known active tuberculosis infection\n* Mean resting corrected QTcF \\> 470 ms\n* In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP\n* In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives\n* Uncontrolled or significant cardiac diseases\n* History of non-infectious Interstitial lung disease (ILD)\u002Fpneumonitis, including radiation pneumonitis that required steroids\n* Has severe pulmonary function compromise\n* Prior exposure to chloroquine\u002Fhydroxychloroquine without an adequate treatment washout period\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention\n* Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment\n* Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention\n* Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload\n* Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention\n* Previous treatment in the present study\n* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study\n* Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies\n* Involvement in the planning and\u002For conduct of the study\n* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements\n* Females that are pregnant, breastfeeding, or planning to become pregnant\n* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd","130 Years",{"count":352,"type":22},454,[26],"TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced\u002FMetastatic Solid Tumours.",[136,356,76,357,314,358,359],"Gastric Cancer","Ovarian Cancer","Urothelial Cancer","Biliary Tract Cancer",[361,362,363,364,365],"TROPION-PanTumor03","Datopotamab Deruxtecan (Dato-DXd)","Solid Tumours","Antibody-drug conjugate (ADC)","Trophoblast cell surface protein 2 (TROP2)","2026-08-12",{"date":258,"type":53},{"date":369,"type":53},"2022-09-06",{"date":371,"type":22},"2027-10-01",{"name":373,"class":92},"AstraZeneca",96,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":61},"100486424","phase-1-dose-escalation-study-of-cabozantinib-in-combination-with-lutetium-177-177lu-psma-617-in-patients-with-metastatic-castration-resistant-prostate-cancer-100486424","NCT05613894","Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer","A Phase Ib Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","CaboLu","Inclusion Criteria:\n\n* Male subject aged ≥ 18 years.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.\n* Prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n* Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation anti-androgen therapies that include, but are not limited to, abiraterone acetate, enzalutamide, apalutamide, and darolutamide.\n* Must be eligible for therapy with 177Lu-PSMA-617 and have ≥ 1 PSMA-positive lesion per treating investigator.\n* Must have progressive mCRPC per the treating investigator.\n* ECOG Performance Status ≤ 1.\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 1500\u002FµL without granulocyte colony-stimulating factor support\n    * White blood cell count ≥ 3000\u002FµL.\n    * Platelet count ≥ 100,000\u002FµL\n    * Hemoglobin ≥ 9g\u002FdL\n    * Serum albumin ≥ 2.5 g\u002Fdl\n    * PT\u002FINR or partial thromboplastin time (PTT) test \\\u003C 1.3x the laboratory ULN\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n    * For subjects with Gilbert's disease: ≤ 3x ULN\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN).\n  * Renal:\n\n    * Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol), or 24-h urine protein ≤ 1 g\n    * Estimated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft-Gault formula Males: ((140-age)×weight\\[kg\\])\u002F(serum creatinine \\[mg\u002FdL\\]×72)\n* Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 6 months after the last dose of study treatment in accordance with section 5.4.2.\n* Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Patients must have a life expectancy \\>3 months.\n\nExclusion Criteria:\n\n* Receiving other investigational anti-cancer agents.\n* Prior treatment with cabozantinib\n* Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to randomization.\n* Previous PSMA-targeted radioligand therapy\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment.\n* Systemic treatment with radionuclides within 6 weeks before first dose of study treatment.\n* Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis).\n* Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment.\n* Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.\n* Major surgery within 4 weeks prior to starting study drug, minor surgery within 10 days, or subjects who have not fully recovered from major surgery.\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast.\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH)\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before the first dose of study treatment.\n    * Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion 14) for at least 1 week before first dose of study treatment.\n    * Uncontrolled hypertension defined as sustained blood pressure (BP) ≥ 150 mm Hg systolic or \\>90 mmHg diastolic despite optimal antihypertensive treatment.\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    * The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n    * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.\n    * Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, social\u002F psychological issues, etc.)\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n* Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n* Lesions invading or encasing any major blood vessels\n* Other clinically significant disorders that would preclude safe study participation.\n\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n  * Uncompensated\u002Fsymptomatic hypothyroidism.\n  * Moderate to severe hepatic impairment (Child-Pugh B or C).\n  * Known history of COVID-19 unless the subject has clinically recovered from the disease at least 30 days prior to first dose of study treatment.\n* Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment or minor surgeries within 10 days before first dose of study treatment.\n* Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment.\n\n  --Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment.\n\n  --Note: If a single ECG shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.\n* Inability to swallow tablets\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n* Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.\n\n  --Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.\n* Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Subjects taking prohibited medications as described in Section 6.8.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.",{"count":342,"type":22},[25],"This is an open-label, phase 1b dose-escalation study of cabozantinib in combination with 177Lu-PSMA-617 in subjects with mCRPC. The primary hypothesis is that cabozantinib with 177Lu-PSMA will be safe and have efficacy in patients with mCRPC. The dose-escalation phase (Part 1) will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the MTD and\u002For recommended dose and schedule for the subsequent expansion phase (Part 2).",[76],"2026-08-11",{"date":366,"type":53},{"date":390,"type":53},"2023-07-14",{"date":392,"type":22},"2028-12",{"name":394,"class":266},"University of Utah",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":415,"locationsCount":417},"100479166","phase-1-study-of-janx007-in-subjects-with-metastatic-castration-resistant-prostate-cancer-engager-psma-01-100479166","NCT05519449","Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)","A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Male ≥18 years of age at the time of signing informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible\n* Adequate organ function\n* For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.\n* For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings\n* For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor\n* For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.\n\nExclusion Criteria:\n\n* Prior solid organ transplant\n* Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy\n* Clinically significant cardiovascular disease\n* For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting\n* For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC\n* For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting\n* For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC\n* Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)\n* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment","100 Years",{"count":404,"type":22},272,[25],"This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).",[39,76,408],"Castration Resistant Prostatic Cancer",[39,410],"Castration-resistant prostate cancer",{"date":258,"type":53},{"date":413,"type":53},"2022-09-15",{"date":392,"type":22},{"name":416,"class":92},"Janux Therapeutics",36,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":442},"100521303","a-study-to-assess-bms-986460-in-participants-with-metastatic-castration-resistant-prostate-cancer-100521303","NCT06067841","A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer","A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.\n* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Participant must have prostate specific antigen (PSA) of ≥ 2 ng\u002FmL at Screening\n* Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)\n\nExclusion Criteria:\n\n* Participant must not have history of brain metastases.\n* Participant must not have impaired cardiac function or clinically significant cardiac disease.\n* Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",{"count":426,"type":22},140,[25],"The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.",[76],[39,410,431,432,148],"Adenocarcinoma of the prostate","Prostatic Neoplasms Castration-Resistant","2026-08-07",{"date":435,"type":53},"2026-08-10",{"date":437,"type":53},"2023-10-18",{"date":439,"type":22},"2031-07-27",{"name":441,"class":92},"Bristol-Myers Squibb",15,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":463},"100634909","study-of-janx014-in-subjects-with-metastatic-castration-resistant-prostate-cancer-100634909","NCT07545811","Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer","Inclusion Criteria:\n\n* Male ≥18 years of age at the time of signing informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* For Dose Escalation: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible.\n* Adequate organ function\n* For Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.\n\nExclusion Criteria:\n\n* Prior solid organ transplant\n* Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy\n* Clinically significant cardiovascular disease",{"count":451,"type":22},43,[25],"This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).",[39,76,455],"Castration-resistant Prostate Cancer","2026-08-06",{"date":435,"type":53},{"date":459,"type":53},"2026-04-15",{"date":461,"type":22},"2029-03",{"name":416,"class":92},4,{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":486},"100615019","phase-2-a-study-to-test-inavolisib-treatment-in-participants-with-metastatic-castration-resistant-prostate-cancer-100615019","NCT07287150","A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer","A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer","InavoPC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features\n* Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA \\>=1 ng\u002FmL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Bone disease progression, defined by PCWG3 criteria, with two or more new metastatic bone lesions on a whole-body radionuclide bone scan\n* Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for hormone- sensitive prostate cancer (HSPC) or CRPC\n* Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Fasting glucose \\\u003C100 mg\u002FdL and HbA1c \\\u003C 5.7%\n\nExclusion Criteria:\n\n* Presence of liver metastasis\n* Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K\u002FAKT\u002FmTOR pathway\n* Type 1 or Type 2 diabetes mellitus\n* Prior treatment for mCRPC with cytotoxic chemotherapy or novel hormonal treatments (e.g., androgen receptor degraders, CYP11 inhibitors), with the following treatments permitted: Prior docetaxel in mHSPC, providing no evidence of disease progression occurred during treatment or within 6 months of treatment completion; Prior docetaxel in the adjuvant or neoadjuvant setting providing no evidence of disease progression occurred during treatment or within 12 months of treatment completion; Prior treatment with sipuleucel-T, with the last dose administered \\>28 days prior to start of treatment; Prior PARPi therapy, as per local prescribing information, with the last dose administered \\>14 days prior to start of treatment; One prior RLT or radiotherapeutic agent (e.g., PSMA-targeted RLT, Radium 223) with the last dose administered \\>8 weeks prior to start of treatment\n* Other concurrent anti-cancer therapy except for androgen deprivation therapy\n* Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment\n* Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment",{"count":473,"type":22},100,[26],"This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.",[106],"2026-08-03",{"date":479,"type":53},"2026-08-05",{"date":481,"type":53},"2026-03-11",{"date":483,"type":22},"2029-07-30",{"name":485,"class":92},"Hoffmann-La Roche",47,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":23,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":514},"100648366","phase-1-a-study-in-patients-with-metastatic-castration-resistant-prostate-cancer-100648366","NCT07719361","A Study in Patients With Metastatic Castration-Resistant Prostate Cancer","A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Confirmed adenocarcinoma of the prostate.\n* PSA levels ≥ 2 ng\u002FmL at screening visit.\n* Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.\n* Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).\n* Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.\n* Acceptable physical functioning and laboratory measurements, per the study protocol.\n* Discontinued prior therapies within protocol-specified timeframes.\n* Commit to use of highly-effective contraception while on study and for 90 days after.\n* Willing and able to adhere to the study visit schedule and other protocol defined requirements.\n\nExclusion Criteria:\n\n* Predominance of small cell carcinoma of the prostate\u002Fneuroendocrine prostate cancer in most recent tumor biopsy.\n* Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.\n* Not recovered from side effects of prior surgery or cancer treatments.\n* Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.\n* Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).\n* Blood clots ≤ 4 weeks prior to start of treatment.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.",{"count":495,"type":22},60,[25],"The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are:\n\nWhat are the side effects of FX-111?\n\nDoes FX-111 work to reduce or prevent progression of mCRPC?\n\nThe study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.",[40,222,499,500,135,501,502,503,504],"mCRPC (Metastatic Castration-resistant Prostate Cancer)","Prostatic Neoplasms","mCRPC or Advanced\u002FMetastatic Solid Tumors","mCRPC, Metastatic Castration Resistant Prostate Cancer","Neoplasms Prostate","Neoplasms of Prostate","2026-07-31",{"date":507,"type":53},"2026-08-04",{"date":509,"type":53},"2026-07-01",{"date":511,"type":22},"2029-02-15",{"name":513,"class":92},"Flare Therapeutics Inc.",10,{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":23,"phases":524,"briefSummary":525,"conditions":526,"keywords":529,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":442},"100615111","phase-1-study-of-gvv858-as-a-single-agent-or-in-combination-with-endocrine-therapy-in-patients-with-hrher2--breast-cancer-and-other-advanced-solid-tumors-100615111","NCT07288359","Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","An Open-label, Multi-center, Phase I\u002FII Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Patients with one of the following histologically or cytologically confirmed advanced cancers:\n\nPhase I (patients with one of the following cancers, from whom no standard therapy is available or appropriate in the judgment of the investigator):\n\n* HR+\u002FHER2- advanced breast cancer (aBC) with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n* Locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n* Metastatic castration-resistant prostate adenocarcinoma, with no documented neuroendocrine component, castrate level of testosterone, and no more than 3 prior lines of systemic therapy for metastatic disease.\n\nPhase II:\n\n* HR+\u002FHER2- aBC with disease progression on or after an endocrine therapy in combination, with a CDK4\u002F6 inhibitor for advanced disease with no more than 2 lines of endocrine therapy and no prior cytotoxic chemotherapy or antibody-drug-conjugate for advanced disease.\n\n  \\- Measurable disease as determined by RECIST v1.1.\n* BC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n* metastatic Castration-Resistant Prostate Cancer (mCRPC) only: If no measurable disease is present per PCWG3 modified RECIST, then at least 1 metastatic lesion must be present on bone scan imaging.\n\nExclusion Criteria:\n\n* Patients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including myocardial infarction (MI), coronary artery bypass graft (CABG), long QT syndrome, or risk factors for Torsades de Pointes (TdP).\n* Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n* Patients with symptomatic visceral disease, including visceral crisis.\n* For patients with BC: Patient is concurrently using hormone replacement therapy.\n* Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":523,"type":22},205,[25,26],"Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization\u002Frecommended dose for further clinical evaluation.\n\nPhase II: Further characterize the safety and tolerability of GVV858 in combination with fulvestrant in patients with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) advanced breast cancer.",[527,528,76],"Advanced HR+\u002FHER2- Breast Cancer","Advanced CCNE1-amplified Solid Tumors",[530,531,532,533,534,39],"GVV858","Fulvestrant","Letrozole","Breast Cancer","CCNE1 amplification","2026-07-29",{"date":537,"type":53},"2026-07-30",{"date":539,"type":53},"2025-12-29",{"date":541,"type":22},"2031-05-09",{"name":168,"class":92},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":550,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":61},"100638106","early-phase-1-chemical-shift-encoded-mri-for-active-bone-marrow-dosimetry-in-radiopharmaceutical-therapy-100638106","NCT07609225","Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patients must be informed of the experimental nature of the study and its potential risks, and must sign institutional review board (IRB) approved consent form indicating such understanding.\n* Individuals at least 18 years of age.\n* Patients must have histologically or cytologically confirmed prostate cancer.\n* Patients must be clinically deemed appropriate for standard of care Lu-177 PSMA RPT.\n* Eastern Cooperative Oncology Group (ECOG) performance 0-2\n* Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging.\n\nExclusion Criteria:\n\n* Patients receiving any concurrent therapy known to impact bone marrow (either stimulate or suppress the marrow, for example G-CSF).\n* Patients treated with chemotherapy or 223Ra radiotherapy within 4 weeks.\n* All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (CTCAE).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements per treating physician discretion.",{"count":442,"type":22},[551],"EARLY_PHASE1","This study compares two different imaging procedures to each other, one using positron emission tomography (PET) with fluorothymidine F-18 (FLT) (FLT PET for short), and the other using chemical shift-encoded (CSE) magnetic resonance imaging (MRI) or CSE-MRI for short, to determine specifically if CSE-MRI is as accurate as FLT PET in telling the difference between active and inactive marrow. The best way to do the comparison between the two imaging procedures is if they are done at the same time on the same patient. This is possible with use of a scanner at the University of Wisconsin Hospitals and Clinics (UW Health), the GE SIGNA PET\u002FMR scanner. The prediction is that CSE-MRI as accurate as FLT at telling the difference between active and inactive marrow in patients with metastatic prostate cancer, and that is the primary reason for this study. 15 participants will be enrolled and on study for up to 14 months.",[76],[555,556,557,222],"FLT PET","CSE-MRI","active bone marrow","2026-07-22",{"date":560,"type":53},"2026-07-23",{"date":562,"type":22},"2026-08",{"date":564,"type":22},"2029-08",{"name":566,"class":266},"University of Wisconsin, Madison",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":61},"100447983","phase-1-abemaciclib-before-177lu-psma-617-for-the-treatment-of-metastatic-castrate-resistant-prostate-cancer-100447983","NCT05113537","Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer","Phase I\u002FII Study of CDK4\u002F6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy","UPLIFT","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation.\n2. Age \\>= 18 years.\n3. Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria.\n4. Patients must have adenocarcinoma histology.\n5. Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc.\n6. Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL)\n7. Patients must have a 68Ga-PSMA-11 PET scan with at least one PSMA-positive lesions (maximum standardized uptake value \\[SUVmax\\] greater than SUVmax of liver) as determined by nuclear medicine review prior to start of lead-in treatment with abemaciclib\n8. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2\n9. Patients must have life expectancy of \\> 6 months\n10. Patients must have adequate organ function as outlined below and bone marrow reserve\n\n    * White blood cell (WBC) \\> 2.5\n    * Absolute neutrophil count (ANC) \\> 1.5\n    * Hemoglobin (Hgb) \\>= 8.0 \\[Note- Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\\]\n    * Platelets (Plt) \\>= 100 x 10\\^9\u002FLiter (100,000\u002FMicroliter)\n    * Total bilirubin =\\\u003C 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =\\\u003C 2 ULN and direct bilirubin within normal limits is permitted\n    * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =\\\u003C 3 X institutional upper limit of normal (=\\\u003C 5.0 ULN for patients with liver metastases)\n    * Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =\\\u003C 3 X institutional upper limit of normal (=\\\u003C 5.0 ULN for patients with liver metastases)\n    * Creatinine =\\\u003C 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m, calculated using the Cockcroft-Gault equation.\n11. Patient must be able to swallow oral medications\n12. Patients must have the ability to understand a written informed consent document, and the willingness to sign it\n13. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n14. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n15. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n16. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n17. Patients with reproductive potential must agree to use effective contraception and to not donate sperm during the study and for at least 2 months following the last dose of study treatment. Effective method of contraception means male condom with spermicide, female condom with spermicide, diaphragm with spermicide, cervical sponge, or cervical cap with spermicide\n\nExclusion Criteria:\n\n1. Patients with small cell or neuroendocrine carcinoma histology.\n2. Patients with a super scan seen in the baseline bone scan. Super scan refers to a bone scan with diffusely increased skeletal radioisotope uptake relative to soft tissue\n3. Patients with prior treatment with CDK4\u002F6 inhibitors\n4. Patients with prior treatment with PSMA-targeted radioligand therapy. Patients with previous treatment with PSMA targeting therapies (Such as Chimeric antigen receptor T cells (CAR-T) or Bi-specific T-cell engagers (BiTEs) are eligible.\n5. Patients treated with Radium-223 within 6 weeks prior to study entry.\n6. Any systemic anti-cancer therapy within 3 weeks of study entry\n7. Patients who have experienced significant radiation-related adverse events (AEs) from prior radiation treatment (\\>= grade 3) or have experienced persistent radiation-related AEs that have not resolved by the time of study randomization\n8. Patients with a history of central nervous system (CNS) metastases are ineligible unless they have received prior therapy (surgery, radiation therapy (RT), gamma knife) are asymptomatic, and not receiving corticosteroids for this indication. Head imaging is not required\n9. Patients with symptoms of cord compression or impending cord compression\n10. Patients with concurrent serious medical conditions as determined by primary investigator\n11. Patients with other significant malignancies that are expected to alter life expectancy or interfere with disease assessment. Patients with adequately treated skin cancer, non-muscle-invasive bladder cancer and patients with prior history of malignancy who have been disease free for more than 2 years are eligible. Patients with history of in-situ\u002Fearly stage melanoma will not be excluded\n12. Patients who have not recovered from adverse events due to prior anti-cancer therapy to =\\\u003C grade 1 or baseline (other than alopecia or peripheral neuropathy)\n13. Patients with serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n14. The patient has active systemic bacterial infection (requiring intravenous (IV) antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive). Screening is not required for enrollment\n15. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n16. Patients currently receiving any other investigational therapeutic agents.",{"count":576,"type":22},30,[25,26],"This phase I\u002FII trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.",[580,581,582,583,584,585,76],"Castration-Resistant Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Stage IV Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","Metastatic Castration-resistant Prostate Carcinoma",{"date":587,"type":53},"2026-07-24",{"date":589,"type":53},"2022-07-08",{"date":591,"type":22},"2028-12-31",{"name":593,"class":266},"Vadim S Koshkin",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":638},"100648541","phase-3-a-study-to-learn-about-the-investigational-drug-rinzimetostat-oric-944-in-patients-with-mcrpc-who-were-previously-treated-with-abiraterone-acetate-himalayas-1-100648541","NCT07723248","A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)","A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)","Himalayas-1","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features\n* Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required\n* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT\u002FMRI scan\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment for prostate cancer at any stage with cytotoxic chemotherapy, radioligand therapy (ie, 177Lu -PSMA-617, radium-223), ARPIs including apalutamide, darolutamide, and enzalutamide, PARP monotherapy or other systemic anticancer treatment (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene or cell therapy, angiogenesis inhibitors, CDK4\u002F6 inhibitors, PRC2 inhibitors) with the following exceptions:\n\n  1. Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication\n  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure or disease progression occurred during treatment or within 3 months of treatment completion\n* Any other anticancer therapy (drug or vaccine which does not meet exclusion criterion 1 above) within 28 days or 5 half-lives (whichever is longer) prior to randomization\n* Known or suspected brain metastasis or active leptomeningeal disease\n* Clinically significant cardiovascular disease defined as:\n* Any medical (including active or clinically significant bacterial, fungal, or viral infection) or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study\n* Active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery are excluded",{"count":603,"type":22},600,[73],"Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or enzalutamide) or docetaxel for treating patients with metastatic castration resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate.\n\nThe primary objective of this study is to demonstrate superiority in radiographic progression free survival (rPFS) of the investigational arm of rinzimetostat + darolutamide combination versus physician's choice of control: ARPI (darolutamide or enzalutamide) or docetaxel.",[40],[608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625,285,626,627,628,289,290,629],"prostate cancer","advanced prostate cancer","hormone dependent malignancy","hormone resistant","relapsed","refractory","androgen receptor (AR) signaling","metastatic castration resistant prostate cancer (mCRPC)","androgen pathway modulator-resistant (APMR)","metastatic castration sensitive prostate cancer (mCSPC)","androgen pathway modulator-naïve\u002Fsensitive (APMN\u002FS)","polycomb repressive complex 2 (PRC2)-controlled dysregulation","embryonic ectoderm development (EED)","enhancer of zeste homolog 2 (EZH2)","ORIC-944","rinzimetostat","mevrometostat","darolutamide","docetaxel","abiraterone","abiraterone acetate","open-label","2026-07-20",{"date":560,"type":53},{"date":633,"type":22},"2026-07",{"date":635,"type":22},"2030-09",{"name":637,"class":92},"ORIC Pharmaceuticals",2,{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":23,"phases":648,"briefSummary":649,"conditions":650,"keywords":651,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":442},"100621082","phase-3-a-phase-iii-trial-of-bnt324-versus-docetaxel-in-metastatic-castration-resistant-prostate-cancer-100621082","NCT07365995","A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer","A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone\u002FPrednisolone in Metastatic Castration-resistant Prostate Cancer","Key Inclusion Criteria:\n\n* Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).\n* Must have documented progressive prostate cancer based on at least one of the following criteria:\n\n  * Serum\u002Fplasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng\u002FmL.\n  * Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.\n  * Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.\n* Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.\n* Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.\n* Must have had prior orchiectomy and\u002For have ongoing androgen-deprivation therapy and a castrate-level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.\n* Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.\n\nKey Exclusion Criteria:\n\n* Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.\n* Have uncontrolled or significant cardiovascular disease, as defined in the protocol.\n* Have a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids or have current ILD\u002Fpneumonitis.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":647,"type":22},736,[73],"This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.\n\nThe main goals of this study are:\n\n* To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival \\[rPFS\\]).\n* To find out if BNT324 helps participants live longer overall (overall survival \\[OS\\]).",[76],[652,364,653,44,654,655,222],"Immunotherapy","Standard of care (SoC)","Steroids","BNT324 (DB-1311)","2026-07-17",{"date":630,"type":53},{"date":659,"type":53},"2026-04-22",{"date":661,"type":22},"2031-02",{"name":663,"class":92},"BioNTech SE",{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":23,"phases":673,"briefSummary":674,"conditions":675,"keywords":676,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":694,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":342},"100556073","phase-3-the-study-of-177lu-tlx591-plus-soc-versus-soc-alone-in-patients-with-mcrpc-prostact-global-100556073","NCT06520345","The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)","A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment","Inclusion Criteria:\n\n* Be a male, at least 18 years old, with documented adenocarcinoma of the prostate defined by histological \u002F pathological confirmation.\n* Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥6 months from Day 1.\n* Have metastatic disease (defined as ≥1 metastatic lesion present on baseline CT, MRI or bone scintigraphy).\n* Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone \\[LHRH\\] analogues) and must have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL) at Screening\n* Must have received a minimum of 12 weeks of prior therapy on an ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide), received in either the mCSPC, nmCRPC, or mCRPC treatment settings, with documented evidence of disease progression while receiving this ARPI. Progression must have occurred on the most recent ARPI. A prior ARPI may have been utilized, but no progression on the prior ARPI is allowed (e,g, ARPI was switched due to poor tolerability or due to adverse events). No washout period is required prior to enrollment into this trial. Participants may have received docetaxel in the mCSPC setting as per the CHAARTED or STAMPEDE treatment regimens (up to 6 cycles of docetaxel), provided the last dose of docetaxel was ≥ 6 months prior to screening and ≥ 4 cycles of docetaxel were administered.\n* Have a disease that is progressing at study entry, despite a castrate testosterone level (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL), by the demonstration of at least one of the following:\n* Two consecutive rising PSA values assessed sequentially at least one week apart, with the final measurement required to be a minimum of 2.0 ng\u002FmL for study entry. Only the last measurement must meet or exceed 2.0 ng\u002FmL.\n* Progressive disease or new lesion(s) in the viscera or lymph nodes as per RECIST1.1 or in bone as per PCWG3. Any ambiguous results are to be confirmed by other imaging modalities (e.g., CT or MRI scan).\n* Have disease that is PSMA-positive, as demonstrated by a 68Ga-PSMA-11 PET\u002FCT or PET\u002FMRI scan and confirmed as eligible by the Sponsor's appointed BICR.\n\nImaging-based eligibility review will be performed in two stages:\n\n1. Presence of metastases for exclusion: Screening CT and MRI will be assessed to exclude participants with brain metastasis with long-axis\\>1cm\n2. PSMA PET eligibility: Screening 68Ga-PSMA-11 PET\u002FCT or PET\u002FMRI will be assessed along with CT, MRI, and bone scans utilizing tumor to liver ratio (TLR) for PSMA positivity-based exclusion. TLR is defined as the ratio of tumor lesion SUVmax to liver SUVmean derived from a 3 cm 3D spherical region of interest (ROI).\n\nPSMA positivity is defined as : At least 1 lesion with PSMA TLR≥2.\n\nPSMA exclusion critieria: The presence of any of the following will result in the patient being ineligible for this trial:\n\ni) visceral metastatic lesions that are ≥1 cm that have a PSMA TLR\\\u003C 1 ii) Lytic bone metastatic lesions with a soft tissue component of at least 1 cm with a TLF \\\u003C1.\n\niii) At least one metastatic lymph node lesion with short axis ≥2.5 cm with a TLF\\\u003C1.\n\n* Must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, ARPI, chemotherapy, etc.) with the exception of alopecia. Specific conditions may be discussed with the medical monitor as needed.\n* Have adequate organ function at Screening:\n\nBone marrow:\n\n* Platelets ≥150×109\u002FL.\n* Absolute neutrophil count ≥1.5 x 109\u002FL.\n* Hemoglobin \\>10g\u002FdL (with no red blood cell transfusion in the previous 4 weeks).\n\nLiver function:\n\n* Total bilirubin ≤ 1.5× the upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3× ULN is permitted.\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3× ULN.\n\nRenal function:\n\n* Creatinine clearance ≥45 mL\u002Fmin determined using the Cockcroft-Gault formula.\n* Must understand the study and agree to adhere to all protocol requirements.\n* Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the public, especially if a female partner of the participant is or could be pregnant.\n* Must agree to practice adequate precautions to prevent pregnancy in a partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1 \\[Clinical Trial Coordination Group {CTCG, 2024}\\]).\n\nExclusion Criteria:\n\n* Is unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the Investigator.\n* Has PC associated with pathological findings consistent with small cell or any histology other than adenocarcinoma of the prostate. If there are minor (\\\u003C20%) elements of neuroendocrine histology, this is acceptable.\n* Participants with a history of other malignancies that could significantly impact life expectancy or interfere with disease assessment will be excluded. Exceptions apply to participants with:\n\n  1. Prior malignancy that has been adequately treated and has remained disease-free for at least 3 years (maybe confirmed by a scan, etc.).\n  2. Adequately treated non-melanoma skin cancer.\n  3. Superficial (non-muscle invasive) bladder cancer that is controlled and stable.\n* Has received prior treatment with monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy.\n* Have received chemotherapy in the mCRPC or non-metastatic prostate cancer (nmCRPC) settings (note: prior docetaxel use in the mCSPC setting with CHAATERED or STAMPEDE regimens is permitted if the last dose of therapy was ≥6 months prior to screening and ≥4 cycles of docetaxel were administered).\n* Has known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients.\n* Has received prior systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, or biological therapy) and\u002For radiation therapy within 4 weeks of enrolment (excluding ARPI and\u002For LHRH analogues).\n\nOR are receiving other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n\n* Has received prior treatment with radioisotopes, including but not limited to: 89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium, or hemi-body irradiation within 6 months prior to enrolment.\n* Has received other investigational therapy within 4 weeks of enrolment.\n* Has known brain metastases with long-axis ≥1cm, or liver metastases with long-axis ≥1cm, or lytic bone metastases with long-axis ≥1cm.\n* Has a history of seizure and\u002For stroke within the past 6 months.\n* Has clinical or radiologic findings indicative of impending spinal cord compression or experience symptomatic spinal cord compression.\n* Has evidence of a serious active or sub-clinical infection or angina pectoris (New York Heart Association \\[NYHA\\] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, that might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment, particularly with enzalutamide.\n* Has received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs.",{"count":672,"type":22},520,[73],"The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment",[76],[677,678,679,82,39,680,681,682,683,222,684,685,686,687,688,689,690,691,692,693],"Radiographic Progression Free Survival","Overall Survival","ARPI","Radionuclide therapy","TLX591","ProstACT Global","PSMA- targeting agent","177Lu-TLX591","mCSPC","nmCRPC","rosopatamab tetraxetan","Lutetium","177-Lutetium","Objective Response Rate (ORR)","PSA","68Gallium-PSMA-PET","Radio-Labelled Antibody Drug Conjugate (rADC)",{"date":695,"type":53},"2026-07-21",{"date":697,"type":53},"2024-07-26",{"date":699,"type":22},"2030-12",{"name":701,"class":92},"Telix Pharmaceuticals (Innovations) Pty Limited",{"id":703,"slug":704,"hasResults":12,"nctId":705,"briefTitle":706,"officialTitle":707,"acronym":708,"eligibilityCriteria":709,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":710,"targetDuration":4,"studyType":712,"phases":4,"briefSummary":713,"conditions":714,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":715,"lastUpdatePostDateStruct":716,"startDateStruct":717,"completionDateStruct":719,"leadSponsor":721,"locationsCount":722},"100545348","real-world-clinical-experience-of-patients-with-metastatic-castration-resistant-prostate-cancer-treated-with-olaparib--abiraterone-proceed-100545348","NCT06380738","Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)","A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone","PROceed","Inclusion Criteria:\n\n* Willing and able to provide written informed consent;\n* 18 years of age and above;\n* Documented histopathology or cytopathology of PCa, adenocarcinoma;\n* Confirmed as mCRPC;\n* Initiated olaparib + abiraterone after site activation\n\nExclusion Criteria:\n\n* Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation",{"count":711,"type":22},250,"OBSERVATIONAL","PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.",[76],"2026-07-16",{"date":656,"type":53},{"date":718,"type":53},"2024-02-14",{"date":720,"type":22},"2027-02-14",{"name":373,"class":92},34,{"id":724,"slug":725,"hasResults":12,"nctId":726,"briefTitle":727,"officialTitle":728,"acronym":4,"eligibilityCriteria":729,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":730,"enrollmentInfo":731,"targetDuration":4,"studyType":712,"phases":4,"briefSummary":733,"conditions":734,"keywords":735,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":739,"lastUpdatePostDateStruct":740,"startDateStruct":742,"completionDateStruct":744,"leadSponsor":746,"locationsCount":747},"100555871","real-world-experience-with-lutetium-vipivotide-tetraxetan-in-metastatic-castration-resistant-prostate-cancer-100555871","NCT06517719","Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer","Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study","Inclusion Criteria:\n\nAll patients must meet the following inclusion criteria during the identification period:\n\n* Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotide tetraxetan by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of Cycle 1.\n* ≥ 18 years old at the time of enrollment\n* Written informed consent must be obtained prior to any data collection\n* Willing to participate in Quality of Life post treatment date collection for 1 year\n\nExclusion Criteria:\n\nPatients must not meet the following exclusion criterion during the identification period:\n\n\\- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan","99 Years",{"count":732,"type":22},500,"The purpose of this study is to describe routine clinical practice with lutetium (177Lu) vipivotide tetraxetan on Health related quality of life (HRQoL) at baseline, on treatment, and post progression.",[40],[736,222,184,737,738],"metastatic castration resistant prostate cancer","lutetium vipivotide tetraxetan","177Lu","2026-07-09",{"date":741,"type":53},"2026-07-13",{"date":743,"type":53},"2024-09-04",{"date":745,"type":22},"2028-02-01",{"name":168,"class":92},38,{"id":749,"slug":750,"hasResults":12,"nctId":751,"briefTitle":752,"officialTitle":753,"acronym":754,"eligibilityCriteria":755,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":756,"targetDuration":4,"studyType":23,"phases":758,"briefSummary":759,"conditions":760,"keywords":763,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":774,"lastUpdatePostDateStruct":775,"startDateStruct":776,"completionDateStruct":778,"leadSponsor":780,"locationsCount":782},"100600863","phase-1-a-clinical-study-of-ktx-2001-in-subjects-with-metastatic-castration-resistant-prostate-cancer-strike-001-100600863","NCT07103018","A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)","Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer","STRIKE-001","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n3. Male participants with mCRPC as defined by PCWG3 criteria.\n4. Metastatic disease documented using bone scan for bone metastases (PCWG3 criteria) or by computed tomography (CT) or magnetic resonance imaging (MRI) for soft-tissue metastases. Evidence of metastasis on prostate-specific membrane antigen positron emission tomography alone will not be sufficient for confirmation of metastatic disease.\n5. Willingness to undergo a baseline and on-treatment biopsy of a metastatic site if safe and feasible. If tissue from a biopsy of a metastatic site (including bone) obtained within the previous 6 months (prior to treatment start) is available, this tissue may be used, and the baseline biopsy may be omitted.\n6. Participants should have progressed on or after receiving an ARPI (eg, abiraterone, enzalutamide, darolutamide, or apalutamide).\n7. Adequate renal function (creatinine clearance \\>50 mL\u002Fmin by serum creatinine).\n8. Adequate hepatic function (total bilirubin ≤1.5× ULN, total bilirubin \\\u003C3× ULN for participants with documented Gilbert's syndrome, AST and ALT ≤2.5× ULN). In case of liver metastases, AST and ALT \\\u003C5× ULN is allowed.\n9. Adequate hematological function (neutrophils \\>1 × 109\u002FL, platelet count \\>100 × 109\u002FL, hemoglobin \\>9 g\u002FdL) with no prior transfusions within 2 weeks.\n\nExclusion Criteria:\n\n1. Presence of symptomatic or uncontrolled brain metastases unless adequately treated, not requiring steroids and stable for the last 28 calendar days before signing the ICF. Participants with leptomeningeal disease are excluded without exception.\n2. Symptomatic or impending cord compression that has not been treated or stabilized.\n3. Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as coagulopathy or encephalopathy), or other reasons which, in the investigator's opinion, could compromise the participant's safety or interfere with or compromise the integrity of the study outcomes.\n4. Presence of a drug-related toxicity from prior cancer therapy that has not resolved to Grade ≤1 (with the exception of alopecia and Grade 2 neuropathy) according to NCI-CTCAE Version 5.0.\n5. Active, uncontrolled, bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. In equivocal cases, participants with a negative viral load may be eligible. Eligibility criteria for HIV-positive participants currently on highly active antiretroviral therapy should be evaluated and discussed with the medical monitor and will be based on current and past CD4 and T cell counts, history (if any) of AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment. Participants with previously treated HBV and HCV with negative viral load are eligible.\n6. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect participation in this study.\n\n   1. QT interval corrected by Fridericia's formula \\>470 msec at screening.\n   2. Unstable cardiovascular function defined as:\n   3. Symptomatic ischemia, or\n   4. Uncontrolled clinically significant conduction abnormalities (ie, ventricular tachycardia on antiarrhythmic agents are excluded; first-degree atrioventricular block or asymptomatic left anterior fascicular block\u002Fright bundle branch block are not excluded), or\n   5. Congestive heart failure New York Heart Association Class ≥3, or\n   6. Myocardial infarction within 3 months of the screening visit.\n   7. Hypertension that cannot be controlled (persistent \\>150\u002F90 mmHg despite optimal medical therapy).\n7. Current use or anticipated need for food or drugs that are known strong CYP3A inducers or inhibitors, including their administration within 10 days or 5 half-lives of the CYP3A inhibitor, whichever is longer prior to first dose of study drug.\n8. Treatment with anticancer therapies including radiotherapy or AR-targeted therapy\u002Fandrogen biosynthesis inhibitor) within 2 weeks prior to initial study drug dose or within 4 weeks for systemic chemotherapy, radioligand therapy, or other systemic anticancer therapies.\n9. Treatment with another investigational agent in the 4 weeks prior to the initial dose of study drug.\n10. Major surgical procedures ≤28 days prior to the initial dose of study drug. Participants must have recovered from any of the effects of any major surgery. No waiting period is required following central venous access placement, biopsy collection, or minor surgeries as long as the investigator assesses the impact on study participation.\n11. Initiation of hormonal agents with antitumor activity against prostate cancer including 5alpha reductase inhibitors, androgens (eg, testosterone), cytoproterone acetate, etc during study participation (from the time of consent to off-study); however, stable use of 5-alpha reductase inhibitors is permitted, if continuous use for ≥6 months.\n12. Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (eg, saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc) within 4 weeks of study drug initiation or plans to initiate treatment with these products\u002Falternative therapies at any point during the study.\n\nFor Part B only (KTX-2001 + darolutamide): Current use or anticipated need for drugs that are known as combined P-glycoprotein (P-gp) and strong or moderate CYP3A4 inducers including their administration within 10 days or 5 half-lives of the combined Pgp\u002FCYP3A4 inducer, whichever is longer prior to first dose of darolutamide.",{"count":757,"type":22},144,[25],"Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.",[76,761,762,222,499],"Metastatic Castration-Resistant Prostate Cancer Patients","Metastatic Castration-resistant Prostate Cancer, mCRPC",[222,106,764,765,289,290,291,292,766,767,768,148,769,500,770,146,771,772,773],"castration-resistant prostate cancer","NSD2 inhibitor","Darolutamide","NUBEQA","Metastatic Disease","prostatic Diseases","Urogenital Neoplasms","Urogenital Diseases","Male Urogenital Diseases","Epigenetics","2026-07-08",{"date":739,"type":53},{"date":777,"type":53},"2025-11-21",{"date":779,"type":22},"2028-09",{"name":781,"class":92},"K36 Therapeutics, Inc.",13]