[{"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,[9,62,93,106,132,155,183,218,240,268,306,326,352,374,423,448,486,516,551,573,594,615,636,647,672],{"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},"100054087","phase-1-docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100054087",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","2026-07-10",{"date":52,"type":53},"2026-07-13","ACTUAL",{"date":55,"type":22},"2026-07-16",{"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":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100053660","real-world-experience-with-lutetium-vipivotide-tetraxetan-in-metastatic-castration-resistant-prostate-cancer-100053660","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","MALE","99 Years",{"count":72,"type":22},500,"OBSERVATIONAL","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],[77,78,79,80,81],"metastatic castration resistant prostate cancer","mCRPC","Prostate cancer","lutetium vipivotide tetraxetan","177Lu","RECRUITING","2026-07-09",{"date":52,"type":53},{"date":86,"type":53},"2024-09-04",{"date":88,"type":22},"2028-02-01",{"name":90,"class":91},"Novartis Pharmaceuticals","INDUSTRY",38,{"id":94,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":27,"conditions":97,"keywords":98,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":61},"100643883",{"count":21,"type":22},[25,26],[29,30,31,32,33,34,35,36,37,38,39,40],[42,43,44,45,46,47,48],"2026-07-01",{"date":101,"type":53},"2026-07-02",{"date":103,"type":22},"2026-07-07",{"date":57,"type":22},{"name":59,"class":60},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100637445","phase-3-azd2265-compared-with-standard-of-care-in-psma-positive-metastatic-castration-resistant-prostate-cancer-vectra-01-100637445","NCT07611110","AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","VECTRA-01","Inclusion Criteria:\n\n* ≥ 18 years of age.\n* Diagnosis of adenocarcinoma of prostate.\n* Must have had prior orchiectomy and\u002For ongoing ADT and a castrate level of plasma\u002Fserum testosterone.\n* Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and\u002For non-measurable) that is suitable for repeated assessment by CT and\u002For MRI and\u002For bone scan.\n* Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.\n* Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.\n* Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).\n* Positive PSMA PET\u002FCT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).\n* ECOG performance status of 0 to 2.\n* Adequate organ and bone marrow function as described in study protocol.\n* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.\n* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.\n\nExclusion Criteria:\n\n* Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).\n* Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.\n* Receipt of \\> 6 cycles of PSMA-directed β-emitting therapeutic RC.\n* History of another primary malignancy, with exceptions.\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.\n* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n* Clinically significant ECG abnormalities, with exceptions.",{"count":115,"type":22},670,[117],"PHASE3","The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.",[120],"Metastatic Castration-resistant Prostate Cancer",[122],"AZD2265; prostate cancer; mCRPC; PSMA; FPI-2265; 225Ac","2026-06-30",{"date":99,"type":53},{"date":126,"type":53},"2026-05-04",{"date":128,"type":22},"2029-12-20",{"name":130,"class":91},"AstraZeneca",104,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":61},"100523822","phase-2-sipuleucel-t-combined-with-bipolar-androgen-therapy-in-men-with-mcrpc-100523822","NCT06100705","Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC","A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Written informed consent obtained prior to the initiation of study procedures.\n* Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator.\n* Histologically confirmed adenocarcinoma of the prostate.\n* Metastatic disease as evidenced by soft tissue and\u002For bony metastases on baseline bone scan and\u002For computed tomography (CT) scan or Magnetic Resonance Image (MRI).\n* Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below:\n\n  1. By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng\u002FmL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.\n  2. By measurable disease: Progressive disease by RECIST v1.1 criteria\n  3. By non-measurable disease\n\n  i. Soft tissue disease: The appearance of 1 or more new lesions, and\u002For unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.\n\nii. Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression.\n\n* Castration status confirmed by serum testosterone level \\<50ng\u002FdL\n* ECOG Performance Status of 0 or 1.\n* Adequate liver function:\n\n  1. Bilirubin \\<2.0 x institutional upper limit of normal (UNL)\n  2. AST (SGOT) \\<2.5 x UNL\n  3. ALT (SGPT) \\<2.5 x UNL\n* Acceptable renal function\n\n  a) Serum creatinine \\<2.0 x UNL\n* Acceptable hematologic function:\n\n  1. Absolute neutrophil count (ANC) \\> 1.0 x10\\^9 cells \u002FL)\n  2. Platelet counts \\> 100 x 10\\^9 \u002F L)\n  3. Hemoglobin \\>9 g\u002FdL\n\nExclusion Criteria:\n\n* PSA \\>20ng\u002FdL within the 4 weeks prior to signing ICF\n* Previously treated with three or more FDA-approved androgen\u002FAR signaling inhibitors (ASI) (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). No minimum number of ASI is required.\n* Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy.\n* Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer.\n* Prior systemic treatment with ASI, PARP inhibitor or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to start of treatment.\n* Prior prednisone \\>10mg (or its equivalent) within 2 weeks prior to registration.\n* Prior immunotherapy or Lu177 PSMA radioligand therapy within 6 weeks prior to registration.\n* Prior palliative radiotherapy within 2 weeks prior to registration.\n* Radiographic evidence of hepatic metastases\n* Use of narcotics including tramadol or stronger for cancer-related pain within 4 weeks prior to signing ICF. Use of NSAIDs or acetaminophen is allowed.\n* Active autoimmune disease requiring systemic corticosteroids of prednisone greater than 10mg a day or the equivalent dose of other corticosteroids.\n* Known active HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 infection. Testing is not required. Note: Participants with resolved, historic HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 will be assessed by the PI and deemed eligible if their viral infections are in remission: without detectable viruses and secondary immunodeficiency, and without requiring any treatments that affects immune function. Eligibility will be determined after a discussion with the PI and adequate standard clinical tests are acquired to prove that they are in remission.\n* Active infection requiring parenteral antibiotic therapy or causing fever (temperature \\>100.5 in Fahrenheit scale) within 1 week prior to registration.\n* Life expectancy of less than 6 months prior to signing ICF.\n* Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.",{"count":140,"type":22},26,[26],"This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).",[120],[145,146],"Sipuleucel-T","Bipolar Androgen Therapy",{"date":99,"type":53},{"date":149,"type":53},"2023-12-20",{"date":151,"type":22},"2028-03",{"name":153,"class":154},"Yale University","OTHER",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"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":163,"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.",[167,168,120],"Advanced HR+\u002FHER2- Breast Cancer","Advanced CCNE1-amplified Solid Tumors",[170,171,172,173,174,39],"GVV858","Fulvestrant","Letrozole","Breast Cancer","CCNE1 amplification","2026-06-29",{"date":123,"type":53},{"date":178,"type":53},"2025-12-29",{"date":180,"type":22},"2031-05-09",{"name":90,"class":91},12,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"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":191,"type":22},900,[117],"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.",[195],"Metastatic Castration-Resistant Prostate Cancer",[197,198,199,200,201,202,78,203,204,205,206,207,208,209],"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":99,"type":53},{"date":212,"type":53},"2024-10-22",{"date":214,"type":22},"2028-11-30",{"name":216,"class":91},"Pfizer",241,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"100546977","phase-2-darolutamide-in-metastatic-castration-resistant-prostate-cancer-mcrpc-100546977","NCT06401980","Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Addition of Darolutamide to First Line Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC): a Randomized Open Label Phase II Trial","Inclusion Criteria:\n\n* Written informed consent according to Swiss law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures\n* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate\n* Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists).\n* Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial\n* Metastatic disease, documented by imaging according to PCWG3 criteria\n* Measurable disease or bone lesions that are evaluable according to PCWG3 criteria\n* A minimum of 12 months on ADT+ARPI therapy (calculated from ADT initiation) within mHSPC setting, showing an at least 50% PSA response or partial remission according to RECIST v1.1. ARPI change within mHSPC is only allowed for intolerance.\n* Progressive disease according to modified PCWG3 before registration is defined as (at least 2 out of 3):\n\n  * PSA progression ≥ 25% above nadir (2 consecutive rises at least 3 weeks apart)\n  * New metastatic lesion on imaging (at least two or more new bone lesions on bone scan or one new non-bone lesion or progression on PSMA-PET\u002FCT according to PROMISE V2 criteria\n  * Clinical progression\n* Patients with a previously treated malignancy are eligible, when the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low\n* Age ≥ 18 years\n* WHO performance status 0-2\n* Adequate bone marrow function: absolute neutrophil count ≥ 1.0 x 109\u002FL, platelet count ≥ 100 x 109\u002FL, hemoglobin ≥ 90 g\u002FL.\n* Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), ALT and AST ≤ 2.5 x ULN, or ≤ 5 x ULN under the assumption that abnormal values are a result of cancer\n* Adequate renal function: estimated glomerular filtration rate (eGFR) \\> 30 mL\u002Fmin\u002F1.73 m2 (according to CKD-EPI formula)\n* Men agree not to donate sperm or to father a child during trial treatment and until 3 months after the last dose of trial treatment\n* Patients are able and willing to swallow darolutamide as whole tablet.\n\nExclusion Criteria:\n\n* Presence of a small cell component\n* Prior systemic therapy for metastatic castration-resistant disease\n* Prior chemotherapy for mHSPC, except docetaxel\n* Prior LuPSMA or radium 223 for prostate cancer\n* Concomitant or recent (within 28 days of registration) treatment with any other experimental drug\n* Concomitant use of other anti-cancer drugs or radiotherapy except for local pain control and GnRH analogues\n* Severe or uncontrolled cardiovascular disease\n* Acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days before expected start of treatment\n* Clinical or radiological evidence of current spinal cord compression\n* Any concomitant drugs contraindicated for use with darolutamide according to the approved product information\n* Known hypersensitivity to darolutamide\n* Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of darolutamide\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":226,"type":22},162,[26],"Despite improvements in treatment, metastatic prostate cancer remains incurable, especially in the case of pretreated metastatic castration-resistant disease (mCRPC), where treatment options are limited, leading to an unmet need. The paradigm shift in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has affected the treatment landscape for mCRPC patients. Many have already received androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI), making first-line mCRPC treatment challenging.\n\nThe Swiss Group for Clinical Cancer Research (SAKK) has shown in previous studies that maintenance treatment with an ARPI, such as darolutamide, can improve radiographic progression-free survival (rPFS) in pretreated mCRPC patients. In the SAKK 08\u002F16 trial, darolutamide maintenance was found to prolong PFS compared to placebo, especially in patients who responded well to prior ARPI treatment.\n\nBased on these findings, the hypothesis is that continued AR-pathway blockade with darolutamide, initiated in patients progressing from mHSPC to mCRPC on ARPI treatment, can improve outcomes when added to standard first-line mCRPC therapy and continued as maintenance. The proposed study aims to evaluate the efficacy of darolutamide, combined with physician-choice standard of care (including taxane chemotherapy, olaparib, radium 223, or LuPSMA), followed by maintenance therapy, on rPFS for patients in the first-line setting of mCRPC.",[120],[195,78,231,232],"Darolutamide","phase II trial",{"date":99,"type":53},{"date":212,"type":53},{"date":236,"type":22},"2030-09",{"name":238,"class":154},"Swiss Cancer Institute",13,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"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":248,"type":22},736,[117],"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\\]).",[120],[253,254,255,44,256,257,78],"Immunotherapy","Antibody-drug conjugate (ADC)","Standard of care (SoC)","Steroids","BNT324 (DB-1311)","2026-06-25",{"date":260,"type":53},"2026-06-26",{"date":262,"type":53},"2026-04-22",{"date":264,"type":22},"2031-02",{"name":266,"class":91},"BioNTech SE",9,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"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":277,"type":22},960,[117],"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.",[120],[79,282,283,284,285,286,287,288,289,290,291,292,293,294,274,295,296,297],"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","Abiraterone","Docetaxel","Enzalutamide",{"date":260,"type":53},{"date":300,"type":53},"2025-03-13",{"date":302,"type":22},"2029-01-19",{"name":304,"class":91},"Celgene",282,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":61},"100559778","phase-2-xl092-in-patients-with-metastatic-castration-resistant-prostate-cancer-100559778","NCT06568562","XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer","PRO-XL: A Phase II Study of XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer After Progression on Lutetium-177 (177Lu)-PSMA-617","PRO-XL","Inclusion Criteria:\n\n* Participant aged ≥ 18 years\n* Disease criteria:\n\n  --Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology\n  * Radiographic evidence of metatstatic disease\n  * Progression on or after prior treatment with 177Lu-PSMA-617 as determined by clinical investigator\n* ECOG Performance Status ≤ 2.\n* Adequate organ function as defined as:\n\n  * Absolute neutrophil count ≥ 1500\u002Fmm3 .\n  * Platelet count ≥ 100,000\u002Fmm3 .\n  * Hemoglobin ≥ 9 g\u002FdL .\n  * Total Bilirubin ≤ 1.5x institutional ULN. For subject's with Gilbert's disease, ≤ 3 x ULN.\n  * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x ULN. For subjects with documented bone metastasis ALP ≤ 5 x ULN. For subjects with CRPC and bone metastasis ALP ≤ 10 x ULN if predominantly bone-specific ALP.\n  * International Normalized Ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 upper limit of normal (ULN)\n  * Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 40 mL\u002Fmin by Cockcroft-Gault formula:\n\n    ---Males: ((140-age)×weight\\[kg\\])\u002F(serum creatinine \\[mg\u002FdL\\]×72)\n  * Urine protein-to-creatinine ratio (UPCR) ≤ 1.5 mg\u002Fmg (≤ 169.8 mg\u002Fmmol) creatinine or 24-hour urine protein \\\u003C1.5 g.\n* Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Section 5.4.1) during the course of the study and for 96 days after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (eg, condom), is required. In addition, men must agree not to donate sperm for the purpose of reproduction during these same periods.\n* Must have recovered from adverse effects of any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy). CTCAE adverse events less than or equal to grade 1 are acceptable. CTCAE adverse events grade 2 or greater may be acceptable as determined by the Clinical Investigator.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Prior treatment with XL092\n* Receipt of any type of small molecule kinase inhibitor, cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 2 weeks or at least 5 half-lives, whichever shorter before first dose of study treatment.\n\nNote: Concomitant use of megestrol acetate, androgen-deprivation therapy and bone loss prevention treatment is permitted. Other types of hormonal therapies with similar use require prior approval from the Principal Investigator.\n\n* Radiation therapy for bone metastasis or any other radiation therapy within 2 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\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 before first dose of study treatment.\n\nNote: Subjects with an incidental finding of an isolated brain lesion \\\u003C 1 cm in diameter may be eligible after Principal Investigator approval if the lesion is radiographically stable for 4 weeks before first dose and does not require treatment per Investigator judgement.\n\nNote: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.\n\n-Concomitant anticoagulation with oral anticoagulants except for those specified below:-\n\n* (a) Prophylactic use of low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose low molecular weight heparins (LMWH) or prophylactic dose of specified direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban\n* (b) Therapeutic doses of LMWH or specified 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 enrollment and without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n\n  * Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks or at least 5 half-lives, whichever shorter before first dose of study treatment.\n  * The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n* Cardiovascular disorders:\n\n  * Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias \\[eg, ventricular flutter, ventricular fibrillation, Torsades de pointes (TdP)\\].\n  * Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n  * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant ischemic event within 6 months before first dose of study treatment.\n  * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-CVA\u002FTIA arterial thromboembolic events within 3 months before to first dose of study treatment.\n\nNote: Subjects with a diagnosis of DVT within 3 months are allowed if asymptomatic and stable at screening and treated with anticoagulation per standard of care before first dose of study treatment.\n\nNote: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n\n--Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n* Tumors invading the GI-tract from external viscera, tumors invading respiratory tracts\n* Active peptic ulcer disease, inflammatory bowel disease including, ulcerative colitis or Crohn's disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n* Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause of obstruction is definitively managed and subject is asymptomatic\n* Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n* Known gastric or esophageal varices\n* Abdominal\u002Fperitoneal carcinomatosis\n* Active perianal abscess\n* History of pelvic or abdominal perforation\n* History of bowel resection unless determined to be low risk of perforation by clinical investigator\n* History of radiation therapy to the abdomen unless determined to be low risk of perforation by clinical investigator\n* Prior GI surgery (particularly when associated with delayed or incomplete healing) unless completely healed and determined to be low risk of perforation by clinical investigator\n\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, 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 major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta.\n\nNote: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval.\n\n* Other clinically significant disorders that would preclude safe study participation.\n\n  * Active infection requiring systemic treatment. Note: Prophylactic antibiotic treatment is allowed.\n  * Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.\n  * Known positive test for or suspected infection with clinically significant SARS-CoV-2 within one month before enrollment. Note: demonstration that the subject has fully recovered from the infection as determined by clinical investigator is required to be eligible for enrollment\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n  * Malabsorption syndrome.\n  * Pharmacologically uncompensated, symptomatic hypothyroidism.\n  * Moderate to severe hepatic impairment (Child-Pugh B or C).\n  * Requirement for hemodialysis or peritoneal dialysis.\n  * History of solid organ or allogeneic stem cell transplant.\n* Major surgery (as defined in Appendix B; eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic nephrectomy within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 10 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\nNote: Fresh tumor biopsies should be performed at least 7 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n\n-Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms for males within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\nNote: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n\n* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n* Inability to swallow tablets.\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n* Any other active malignancy or diagnosis of another malignancy within 2 years before first dose of study treatment requiring systemic treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.\n\nNote: Patients with 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 as approved by the Principal Investigator.\n\n* Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* Participants taking prohibited medications as described in Section 6.8. 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":315,"type":22},32,[26],"The purpose of this study is to determine how well the study drug XL092 is helping to treat a participant's cancer after 16 weeks of treatment. Researchers will also look at how safe the XL092 is and how well the XL092 is working. XL092 is an oral tablet that will be taken once a day. Participants will return to clinic for regular visits for checkups and tests.",[120],{"date":175,"type":53},{"date":321,"type":53},"2024-12-09",{"date":323,"type":22},"2028-12",{"name":325,"class":154},"University of Utah",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"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.",{"count":334,"type":22},750,[117],"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).",[120],[39,339,340,295,341,296,342],"Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Xaluritamig","Abiraterone Acetate","Cabazitaxel","2026-06-24",{"date":258,"type":53},{"date":346,"type":53},"2025-11-28",{"date":348,"type":22},"2032-08-30",{"name":350,"class":91},"Amgen",136,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":373},"100557094","phase-2-a-study-of-sync-t-therapy-sv-102-in-participants-with-metastatic-castration-resistant-prostate-cancer-100557094","NCT06533644","A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer","A Phase 2a Multicenter, Dose-Escalation and Dose Optimization Study of SYNC-T Therapy SV-102 for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Male \\>=18 years old.\n* Able to provide written informed consent and comply with the study procedures.\n* Participants with advanced and\u002For metastatic histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology or neuroendocrine transformation.\n* Serum testosterone levels less than or equal to (\\\u003C=) 0.5 nanograms per millilitre (ng\u002FmL) (\\\u003C=1.73 nanomoles per litre \\[nmol\u002FL\\]) at screening if on an androgen receptor prostate inhibitor in combination with Androgen Deprivation Therapy (ADT).\n* Progression (as defined below) after the receipt of at least one or more approved second-generation androgen-receptor-pathway inhibitors with or without a prior course of taxane therapy, as long as the subject has not received more than three lines of therapy in the CRPC setting. If a subject is known positive for any of the specific gene mutations of BRCA1\u002F2, PALB2, or HRD and chose not to receive an approved PARP-inhibitor they are eligible for the study. Documented progressive disease at screening as assessed by the Investigator with at least one of the following criteria:\n* Serum\u002Fplasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart. 1.0 ng\u002FmL is the minimal starting value if confirmed rise is only indication of progression.\n* Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3).\n* Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression.\n* Able to undergo general anesthesia, MAC anesthesia, or conscious sedation.\n* Eastern Cooperative Oncology Group (ECOG) performance status of less than (\\\u003C) 2.\n* Life expectancy \\>=6 months\n* Last dose of previous anticancer therapy (excluding hormonal therapy) must by 28 days prior to first study treatment. For subjects who previously received lutetium Lu 177 vipivotide tetraxetan (Pluvicto®), the last dose must have been administered \\> 90 days prior to first study treatment. Subjects may remain on ADT and\u002For androgen receptor pathway inhibitor at time of study entry, per Investigator discretion.\n* Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy.\n* For males with female partners of childbearing potential, even if surgically sterilized (that is \\[i.e.\\], status post vasectomy), who agree to practice:\n\n  1. effective barrier contraception during the treatment period and through 120-150 days after last dose, OR\n  2. true abstinence, when this is in line with the preferred and usual lifestyle of the participants. Periodic abstinence (for example \\[e.g.\\], calendar, ovulation, symptothermal, post ovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.\n* Must have at least one measurable lesion per RECIST v1.1 at time of screening.\n* Must have at least one lesion suitable for SYNC-T Therapy identified by radiographic imaging as defined below:\n* Soft tissue lesion (e.g., prostate, lung) must be at least 1 cm in at least two dimensions.\n* Lymph node lesion of at least 1.5 cm (short axis) or 1.0 cm if positive per PET scan.\n* Exophytic component of a bone lesion that is measurable per RECIST v1.1. Soft tissue and lymph nodes must be demonstrable on CT\u002FMRI and accessible either transperineally or percutaneously to permit tumor biopsy, cryolysis, and immunotherapy infusion.\n\nThe eligible tumor lesion for intratumoral infusion cannot be a tumor that is adjacent to vital structures such as major nerves or blood vessels or at risk of airway compromise in the event of post-infusion tumor swelling\u002Finflammation.\n\n* Participants receiving bone resorptive therapy must be on stable doses for at least 42 days prior to the oncolysis.\n* In the opinion of the Investigator, there is no other meaningful life prolonging therapy option available, or the participant refuses other therapy, outside of anti-hormonal therapy.\n* Adequate bone marrow, renal, and hepatic function.\n* Participants agrees to provide tumor tissue and undergo an on-treatment tumor biopsy.\n\nExclusion Criteria:\n\n* Has a known other primary malignancy other than prostate cancer that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of the breast.\n* Has an obstructed urinary system before or after stenting.\n* Has undergone major surgery, including local prostate intervention (excluding prostate biopsy), within 28 days prior to the first dose of study treatment and has not recovered adequately from the toxicities and\u002For complications.\n* Has used any anticoagulants or other blood thinners pre-study treatments within the protocol-defined timelines.\n* Has an active infection (including tuberculosis) requiring systemic therapy.\n* Has a history of non-infectious pneumonitis that requires steroids.\n* Has received a live vaccine within 30 days prior to the planned first study treatment.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first study treatment.\n* Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g., New York Heart Association Class 4), or history of previous heart failure.\n* Fridericia corrected QT interval (QTcF) greater than (\\>) 470 millisecond (msec) (men) on a 12-lead electrocardiogram (ECG) during the screening period.\n* Malignant pleural effusions or ascites that require immediate intervention.\n* Brain metastases (includes history of).\n* Immunocompromised status due to:\n\n  * Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.\n  * Other immunodeficiency diseases that in the opinion of the Investigator, with consultation with Medical Monitor, could compromise the participant or limit treatment efficacy.\n* Uncontrolled or unmanaged diabetes, hypersensitivity, or other illness or disease that in the opinion of the Investigator, with consultation with Medical Monitor (MM), makes the subject a poor candidate.\n* History of bone marrow\u002Fstem cell transplant.\n* Participants having human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) are not eligible for enrollment.\n* Active coronavirus disease-2019 (COVID-19) infection or tests positive for COVID-19 a day before or the day of planned study treatment.\n* Participants who have active viral (any etiology) hepatitis are excluded.\n* Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody (anti-HBc) test) who have a viral load below the limit quantification (HBV deoxyribonucleic acid \\[DNA\\] titer \\\u003C1000 copies per milliliters \\[cps\u002FmL\\] or 200 international units per milliliter \\[IU\u002FmL\\]) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor.\n* Participants with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification are eligible for study entry. Known or suspected hepatitis C infection which has not been treated and cured are not eligible. Known or suspected hepatitis C currently on treatment with an undetectable viral load are eligible. Patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification are eligible for study entry.\n* Participants with complications or contraindications related to the liver, including intrahepatic biliary ductal dilation, uncorrectable bleeding diathesis, and decompensated liver failure.\n* Breast cancer gene (BRCA) mutation testing will be required for participants not previously treated with a PARP inhibitor, unless BRCA status is established prior to screening. If PARP-positive and participants agree to PARP therapy, they will be ineligible.\n* Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study treatment, or interfere with participants compliance or conduct of this study.\n* Known visceral metastases, except for lung metastases.\n* Known substance abuse or medical, psychological, or social conditions that may interfere with patient's participation.\n* Participants who have received both chemotherapy and lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in the CRPC setting.",{"count":360,"type":22},91,[26],"The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of SYNC-T Therapy SV-102 and to identify the maximum tolerated dose (MTD) and\u002For selected dose for phase 2b study.",[120],"2026-06-22",{"date":366,"type":53},"2026-06-23",{"date":368,"type":53},"2025-05-29",{"date":370,"type":22},"2028-04-14",{"name":372,"class":91},"Syncromune, Inc.",23,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":384,"conditions":385,"keywords":393,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":422},"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":382,"type":22},275,[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.",[386,387,388,389,390,391,392,120],"Advanced Solid Tumor","Diffuse Large B Cell Lymphoma","Lymphoma, T-Cell","Mesothelioma, Malignant","Prostatic Neoplasms, Castration-Resistant","Endometrial Cancer","Ovarian Clear Cell Carcinoma",[394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,391,392,411,412,413,414],"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)","2026-06-17",{"date":364,"type":53},{"date":418,"type":53},"2019-09-18",{"date":420,"type":22},"2030-02-27",{"name":90,"class":91},81,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":61},"100586971","phase-2-the-cosmyc-trial-combined-suppression-of-myc-100586971","NCT06922318","The COSMYC Trial (COmbined Suppression of MYC)","A Phase II Study of Sequential Bipolar Androgen Therapy and ZEN-3694 in Sequence With Enzalutamide + ZEN-3694 in Asymptomatic Patients With Metastatic CRPC: The COSMYC Trial (COmbined Suppression of MYC)","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.\n2. Age ≥18 years.\n3. Histologically-confirmed adenocarcinoma of the prostate.\n4. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist\u002Fantagonist).\n5. Documented castrate level of serum testosterone (\\\u003C50 ng\u002Fdl).\n6. Metastatic disease radiographically documented by CT or bone scan. While CT scan is preferred, Prostate-Specific Membrane Antigen (PSMA) scan (e.g. Pylarify) may be substitute for CT scan if evidence of metastatic disease observed on the CT portion of the PSMA scan.\n7. Must have had disease progression while on a second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) based on:\n\n   PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart i. And\u002F Or Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions or PCWG3 for patients with bone disease\n8. Screening PSA must be ≥ 1.0 ng\u002FmL.\n9. Patients with soft tissue lesion amenable to biopsy must agree to biopsy collection pre-treatment and at a defined point on treatment to perform tumor tissue analysis.\n10. Prior treatment with Provenge vaccine, 223 Radium (Xofigo), poly(ADP-ribose) polymerase (PARP) inhibitors, taxane chemotherapy, Pluvicto, antiandrogens (including enzalutamide, darolutamide, and apalutamide), and radiation is allowed if \\>4 weeks from last dose.\n11. Prior treatment with BAT is allowed if the patient has progressed on an AR-axis inhibitor (i.e. abiraterone or antiandrogen) since BAT treatment.\n12. Patients must be withdrawn from second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) for ≥ 2 weeks.\n13. Attempts must be made to wean patients off prednisone prior to starting therapy. Patients who cannot be weaned due to symptoms may continue on lowest dose of prednisone achieved during weaning period.\n14. Acceptable liver function:\n\n    1. Bilirubin \\\u003C 2.5 times institutional upper limit of normal (ULN)\n    2. Aspartate Transferase (AST) (SGOT) and Alanine Transaminase (ALT) (SGPT) \\\u003C 2.5 times ULN\n15. Acceptable renal function:\n\n    a. Serum creatinine \\\u003C2.5 times ULN\n16. Acceptable hematologic status:\n\n    1. Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3 (1.5 ×109\u002FL)\n    2. Platelet count ≥ 100,000 platelet\u002Fmm3 (100 ×109\u002FL)\n    3. Hemoglobin ≥ 7.5 g\u002FdL.\n17. Ability to understand and willingness to sign a written informed consent document.\n18. Sexually active participants with female partners of childbearing potential are eligible to participate if they agree to follow 1 of the following methods of contraception consistently, starting from screening, during the study and for at least 3 months after the last dose of ZEN-3694 and\u002For enzalutamide:\n\n    i. Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.\n\n    ii. Are sterilized (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); iii. Agree to use a male condom and have their partner use a contraceptive method with a failure rate of \\\u003C1% per year as described below when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant, and who agrees to the use of a condom by her partner.\n\n    b. In addition, participants must refrain from donating sperm starting from Screening, during the study and for at least 3 months after the last dose of ZEN-3694 and\u002For enzalutamide.\n19. Sexually active participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse; or use a male condom during each episode of penile penetration during the study\n20. Patients with soft-tissue disease amenable to biopsy as determined by Interventional Radiology must agree to serial biopsies as per the study schedule to be eligible.\n\nExclusion Criteria:\n\n1. Pain due to metastatic prostate cancer requiring treatment intervention with opioid pain medication.\n2. ECOG Performance status ≥3\n3. Requirement for urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible.\n4. Active uncontrolled infection. Patients with a history of HIV\u002FAIDS may be eligible if cluster of differentiation 4 (CD4)+ T cell counts are ≥ 350 cell\u002Ful, they have had no opportunistic infection within the past 12 months, they have been on established antiretroviral therapy (ART) for at least four weeks, the HIV viral load is less than 400 copies\u002Fml prior to enrollment, and there is no significant drug-drug interaction with ART and the study drugs. Patients with chronic hepatitis B virus (HBV) infection with active disease who meet criteria for anti HBV therapy are eligible if they are on a suppressive antiviral therapy prior to enrollment and there is no drug-drug interaction with the study drugs. Patients with a history of HCV infection are eligible if they have completed curative antiviral treatment and the hepatitis C virus (HCV) viral load is below the limit of quantification.\n5. Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator.\n6. Patients receiving anticoagulation therapy with warfarin, rivaroxaban, or apixaban are not eligible for study. \\[Patients on enoxaparin or edoxaban are eligible for study. Patients on warfarin, rivaroxaban, or apixaban, who can be transitioned to one of these alternative agents prior to starting study treatments will be eligible\\].\n7. Patients are excluded with prior history of a thromboembolic event within the last 12 months that are not being treated with systemic anticoagulation.\n8. Hematocrit \\>51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure \\[per Endocrine Society Clinical Practice Guidelines (34)\\]\n9. Patients allergic to sesame seed oil or cottonseed oil are excluded.\n10. Major surgery (i.e. as defined by treating physician) within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n\nPatients with history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma, brain arteriovenous malformation).",{"count":431,"type":22},50,[26],"This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.",[120],[39,436,437,438,202],"ZEN-3694","Bipolar androgen therapy","testosterone cypionate","2026-06-16",{"date":441,"type":53},"2026-06-18",{"date":443,"type":53},"2025-08-19",{"date":445,"type":22},"2031-08-30",{"name":447,"class":154},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":460,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":485},"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":456,"type":22},520,[117],"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",[120],[461,462,463,296,39,464,465,466,467,78,468,469,470,471,472,473,474,475,476,477],"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":441,"type":53},{"date":480,"type":53},"2024-07-26",{"date":482,"type":22},"2030-12",{"name":484,"class":91},"Telix Pharmaceuticals (Innovations) Pty Limited",31,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":23,"phases":496,"briefSummary":497,"conditions":498,"keywords":504,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":515},"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":495,"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.",[391,499,120,500,501,502,503],"Gastric Cancer","Ovarian Cancer","Colorectal Cancer","Urothelial Cancer","Biliary Tract Cancer",[505,506,507,254,508],"TROPION-PanTumor03","Datopotamab Deruxtecan (Dato-DXd)","Solid Tumours","Trophoblast cell surface protein 2 (TROP2)",{"date":415,"type":53},{"date":511,"type":53},"2022-09-06",{"date":513,"type":22},"2027-10-01",{"name":130,"class":91},96,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":532,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":61},"100643460","phase-1-dual-target-psmapsca-car-nk-cells-in-advanced-prostate-cancer-100643460","NCT07641049","Dual-target PSMA\u002FPSCA CAR-NK Cells in Advanced Prostate Cancer","A Phase 1, Open-Label, Multicenter, Dose-Escalation and Dose-Expansion Study of ETB-DualNK-01, an Allogeneic Dual-target PSMA\u002FPSCA CAR-NK Cell Product, in Adults With Metastatic Castration-Resistant Prostate Cancer","DUAL-NK-PC","Inclusion Criteria:\n\n* Male participant age 18 years or older.\n* Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant disease.\n* Disease progression by PCWG3 while maintaining castrate testosterone (\\\u003C50 ng\u002FdL) with ongoing androgen deprivation therapy or prior orchiectomy.\n* Documented PSMA and\u002For PSCA expression by a validated tumor assay; PSMA PET may support target confirmation when applicable.\n* Prior progression on at least one androgen receptor pathway inhibitor such as abiraterone, enzalutamide, apalutamide, or darolutamide; prior taxane, PARP inhibitor, radioligand therapy, or checkpoint inhibitor is allowed.\n* ECOG performance status 0 or 1.\n* Adequate hematologic, renal, hepatic, cardiac, and pulmonary function per protocol laboratory thresholds.\n* At least one measurable lesion by RECIST 1.1 or evaluable bone-predominant disease by PCWG3.\n* Life expectancy of at least 12 weeks.\n* Ability to understand and sign informed consent and willingness to provide required blood and tissue samples.\n\nExclusion Criteria:\n\n* Active central nervous system metastases or leptomeningeal disease.\n* Dominant small-cell or neuroendocrine prostate cancer histology.\n* Prior gene-modified cellular therapy within 6 months before lymphodepletion, or prior allogeneic transplant requiring ongoing systemic immunosuppression.\n* Active autoimmune disease requiring systemic treatment or chronic immunosuppression; systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days of lymphodepletion.\n* Uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection.\n* Clinically significant cardiovascular disease, symptomatic arrhythmia, recent myocardial infarction, or uncontrolled heart failure.\n* Unresolved grade 2 or higher toxicity from prior anticancer therapy, except alopecia, stable endocrinopathy, or other protocol-approved exceptions.\n* Another active malignancy requiring systemic treatment.\n* Any medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, would increase risk or interfere with study interpretation.",{"count":525,"type":22},36,[25],"This example Phase 1 study is designed to evaluate the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01, an allogeneic dual-target PSMA\u002FPSCA CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer (mCRPC). Part A uses dose escalation to determine the maximum tolerated dose and\u002For recommended Phase 2 dose. Part B expands at the selected dose in biomarkerconfirmed disease.",[120,529,530,531],"Advanced Prostate Adenocarcinoma","PSCA-positive Prostate Cancer","PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer",[533,534,535,536,78,537,538,539,540,541],"CAR-NK","dual-target","PSMA","PSCA","metastatic prostate cancer","cell therapy","immunotherapy","dose escalation","dose expansion","2026-06-06",{"date":544,"type":53},"2026-06-11",{"date":546,"type":53},"2026-03-02",{"date":548,"type":22},"2028-06-17",{"name":550,"class":91},"Beijing Biotech",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":315},"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":560,"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.",[195],"2026-06-03",{"date":566,"type":53},"2026-06-04",{"date":568,"type":53},"2026-03-11",{"date":570,"type":22},"2029-07-30",{"name":572,"class":91},"Hoffmann-La Roche",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":593},"100518535","prostate-olaparib-real-world-evidence-study-100518535","NCT06031805","PRostate Olaparib Real World Evidence Study","A French Observational Longitudinal Multicenter Study of Adult Patients Treated in the Real-life Setting With Olaparib for the Treatment of Metastatic Castration Resistant Prostate Cancer","PROWESs","* Adult male patients (≥ 18 years old)\n* with metastatic castration-resistant prostate cancer,\n* who have initiated olaparib within at least, the last two months of study entry, at their physician's discretion or who have been enrolled in the funded early access program\n* who have been informed and are not opposed to their data collection --- For Patients initiated with olaparib in fEA,\n\n  * Still alive and who have been informed verbally and\u002For in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control (certified by physician);\n  * who deceased and who did not object to data collection for research purpose(s) during his or her lifetime.\n\nExclusion criteria\n\n* Patients opposed to the collection of their data\n* Patients participating in a clinical trial with an investigational prostate cancer targeted drug within 30 days prior to Olaparib initiation",{"count":582,"type":22},300,"This French non-interventional longitudinal multicenter cohort study is conducted to study the added value of olaparib in the treatment of patients with mCRPC in the real world setting in terms of treatment sequencing, effectiveness, safety and BRCA testing patterns and thus inform future clinical practice.",[120],"2026-06-01",{"date":587,"type":53},"2026-06-02",{"date":589,"type":53},"2023-10-11",{"date":591,"type":22},"2028-10-13",{"name":130,"class":91},65,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":614},"100619414","phase-1-a-phase-i-trial-of-a-car032-in-participants-with-mcrpc-100619414","NCT07344311","A Phase I Trial of A-CAR032 in Participants With mCRPC","First Time-in-Human (FTiH), Phase I Trial to Evaluate the Safety, Cellular Kinetics, and Efficacy of A-CAR032, in Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n1. Participant must be 18 years or older at the time of signing the ICF. Type of Participant and Disease Characteristics\n2. Participants with:\n\n   1. A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features.\n   2. Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone analogue. Participants receiving medical castration therapy with gonadotropin-releasing hormone analogues should continue this treatment during the study.\n   3. Measurable PSA≥1 ng\u002FmL AND\n   4. Evidence of progression within 6 months prior to screening\n3. Participant has previously received an ARPI (ie, abiraterone, enzalutamide, apalutamide, darolutamide, rezvilutamide) whether before or in the metastatic castration-resistant setting, and in the judgment of the investigator, be ineligible for standard treatment.\n4. Minimum life expectancy of \\> 12 weeks prior to apheresis in the opinion of the investigator.\n5. Adequate organ and marrow function\n6. Consent and provision of tumour material to assess STEAP2 expression and other correlative biomarkers retrospectively with pre- and post-treatment biopsies.\n7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n8. The participant voluntarily participates in the study, and the individual or their legal guardian signs the ICF.\n\nExclusion Criteria:\n\n1. Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO).\n2. Contraindication to lymphodepleting agents, including fludarabine and\u002For cyclophosphamide.\n3. History of another primary malignancy except for:\n\n   1. Malignancy treated with curative intent and with no known active disease within 3 years before the apheresis and of low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease.\n4. Participants with known brain metastases.\n5. History of splenectomy or organ transplantation.\n6. Prior treatment with:\n\n   1. Any CAR-T therapy. OR\n   2. Any therapy that is targeting STEAP2.\n7. Active or prior documented autoimmune or inflammatory disorders\n8. Cardiac arrhythmias which are symptomatic or require treatment unless controlled by pacemaker (judged by investigator); symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.\n9. Active infection, including:\n\n   1. HBV infection is defined as hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and HBV DNA detectable.\n   2. HCV infection is defined as HCV antibody positive and HCV RNA positive.\n   3. CMV infection is defined as CMV DNA detectable.\n   4. Syphilis infection is defined as syphilis antigen and antibody positive.\n   5. HIV infection is defined as HIV 1\u002F2 antibody positive.\n   6. Other persistent or active infections requiring systemic treatment (prophylactic use of anti-infective drugs is allowed).\n10. Patients with central nervous system (CNS) diseases:\n11. Obvious risk or tendency of bleeding or active bleeding (eg, clinically significant hemoptysis, tumour bleeding, history of von Willebrand disease or hemophilia etc.).\n12. Plans to father a child during the study period.\n13. Patients with alcohol or drug abuse.\n14. Participants may not receive full-dose long acting oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose from the time of informed consent to 28 days post infusion of A-CAR032. Use of short acting direct oral anticoagulants for therapeutic and prophylactic purposes are permitted.\n15. Received the following:\n\n    1. Major surgery within 4 weeks prior to apheresis or existence of unhealed wound, or planned major surgery within 4 weeks of the study treatment administration\n    2. Steroids (except inhaled steroids) or other immunomodulators (including interleukins, interferons, and thymosins) of systemic therapeutic dose, and systemic corticosteroids at doses exceeding 10 mg\u002Fday of prednisone or equivalent within 5 half-lives or 7 days (whichever is shorter) prior to apheresis.\n16. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies, investigational product) within 5 half-lives or ≤ 21 days (whichever is shorter) prior to apheresis.\n17. Radiotherapy within 4 weeks of apheresis (However, if the radiation portal covered ≤ 5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy); or within 6 months or 5 half-lives (whichever is longer) if local radioactive particle implantation was performed.",{"count":602,"type":22},27,[25],"This FTiH, single-arm, open-label, investigator-initiated Phase I trial will evaluate the safety, antitumour activity, CK\u002Fpharmacodynamics (PD), biomarkers, immunogenicity, and feasibility of A-CAR032 in adult participants with mCRPC, who have previously progressed after ARPI treatment of prostate cancer (whether before or in the metastatic castration-resistant setting) and, in the judgment of the investigator, are ineligible for standard treatment.",[39,195],"2026-05-29",{"date":585,"type":53},{"date":609,"type":53},"2026-01-13",{"date":611,"type":22},"2042-01-31",{"name":613,"class":91},"Shanghai AbelZeta Ltd.",5,{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":23,"phases":625,"briefSummary":626,"conditions":627,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":635},"100533610","phase-2-study-of-sx-682-plus-enzalutamide-in-men-with-arpi-resistant-metastatic-castration-resistant-prostate-cancer-100533610","NCT06228053","Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer","A Phase 2, Single-Arm Study of the CXCR1\u002F2 Inhibitor SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer, the SYNERGY-201 Trial","SYNERGY-201","Inclusion Criteria:\n\n1. Signed and dated Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)-approved informed consent form prior to beginning study and undergoing procedures.\n2. 2\\. Diagnosis of mCRPC with (a) any histology, and (b) currently on or previously on abiraterone\u002Fprednisone (or abiraterone\u002Fdexamethasone) or darolutamide, apalutamide or enzalutamide with documented progression in either the mCRPC or mHSPC settings, and currently with:\n\n   * rising PSA (a rising PSA requires at least 3 measurements obtained at least 1 week apart showing increase from nadir with the last level above 2 ng\u002FmL by local testing); or\n   * progression of new or existing bone or soft tissue metastatic lesions by CT, MRI or bone scan; no washout necessary.\n3. Availability of archival tumor tissue for pathologic review and correlative studies. Tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and blocks) upon later request for future pathologic review and possible correlative studies.\n4. Castrate levels of serum total testosterone (\\\u003C50 ng\u002Fdl) OR ongoing documented ADT.\n5. Karnofsky performance status of 70 or higher.\n6. ≥ 18 years of age\n7. Life expectancy of ≥ 6 months\n8. Recovered to ≤ Grade 2 toxicity from prior therapy (per CTCAE Version 5.0)\n9. Adequate bone marrow function:\n\n   * Absolute neutrophil count (ANC) ≥ 1.2 × 10\\^9\u002FL without any growth factors in prior 7 days\n   * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the prior 14 days\n   * Platelet count ≥ 75 × 10\\^9\u002FL with no platelet transfusion in the prior 7 days\n\n   Adequate hepatic function:\n   * Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome)\n   * AST (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F ALT (serum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n\n   Adequate renal function:\n\n   \\- Creatinine clearance per Cockcroft-Gault equation (or institutional equivalent) of ≥ 50 mL\u002Fmin\n10. Willingness of patients who are not surgically sterile or with partners who are not postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment, including 90 days after the last dose of study drug.\n11. Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.\n\nExclusion Criteria:\n\n1. Prior systemic anticancer treatment:\n\n   * Prior treatment with docetaxel or marketed antibody within 4 weeks of first dose of study treatment\n   * Prior radium-223 therapy within 6 weeks\n   * Prior PSMA-Lu177-617 therapy within 4 weeks\n2. 2\\. Prior receipt of (a) ketoconazole, (b) 2 or more chemotherapy regimens with docetaxel or (c) any chemotherapy other than docetaxel.\n3. Current presence of liver metastases on imaging.\n4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n5. Major surgery requiring general anesthesia within 3 weeks of starting study treatment (limited biopsy or line placement is acceptable)\n6. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n8. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n9. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris; previous history of myocardial infarction within one year prior to study entry, uncontrolled hypertension, or uncontrolled arrhythmias.\n10. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n11. Has known active untreated CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment greater than prednisone 10 mg daily (or equivalent) for at least 14 days prior to first dose of study intervention.\n12. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n13. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n14. Has an active infection requiring systemic therapy.\n15. Has a known uncontrolled Human Immunodeficiency Virus (HIV) infection based on detectable HIV viral load and abnormal CD4 count of \\\u003C350\u002Fmm\\^3.\n16. Has a known active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n17. Has a known active TB (Bacillus Tuberculosis) infection.\n18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n19. Has known current psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n20. Has had an allogenic tissue\u002Fsolid organ transplant.\n21. Concomitant medication(s) known to be (a) a strong inhibitor or inducer of CYP3A4, or (b) QT prolonging as defined in the drug's approved label, with the exception of drugs that are considered absolutely essential for the care of the subject or if the Investigator believes that beginning therapy with such medication is vital to an individual subject's care while on study, and in either case, there is no alternative drug (if exceptions apply contact Syntrix medical monitor prior to enrollment).\n22. ECG demonstrating a QTcF interval \\> 470 msec or patients with congenital long QT syndrome.\n23. Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure in the last 6 months.",{"count":624,"type":22},53,[26],"The goal of this clinical trial is to study the combination of SX-682 plus enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who have failed prior therapy with androgen receptor pathway inhibitors.",[120],{"date":587,"type":53},{"date":630,"type":53},"2024-11-18",{"date":632,"type":22},"2028-06-30",{"name":634,"class":91},"Syntrix Biosystems, Inc.",6,{"id":637,"slug":4,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":70,"enrollmentInfo":638,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":639,"keywords":640,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":644,"leadSponsor":645,"locationsCount":646},"100555871",{"count":72,"type":22},[40],[77,78,79,80,81],"2026-05-28",{"date":585,"type":53},{"date":86,"type":53},{"date":88,"type":22},{"name":90,"class":91},37,{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":69,"minAge":18,"maxAge":654,"enrollmentInfo":655,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":657,"conditions":658,"keywords":659,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":665,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":671},"100555625","post-marketing-study-on-pluvicto-in-korea-100555625","NCT06514521","Post Marketing Study on Pluvicto in Korea","A Post Marketing Surveillance on PluvictoTM (Lutetium(177Lu) Vipivotide Tetraxetan) in South Korea; An Open-label, Non-interventional, Primary Data Collection, Multi-center, Non-comparative, Non-randomized Observational Study to Assess Safety and Effectiveness of Pluvicto in Real World Setting","Inclusion criteria\n\nStudy participants eligible for inclusion in this study must meet all of the following criteria:\n\n1. Male adult patient age ≥ 18\n2. Subject who are being treated with Pluvicto or whose treatment plan is finalized and scheduled to be administered at the time of consent by physician in accordance with the approved indication in South Korea\n3. Subject who provided the written informed consent prior to the study enrollment\n\nExclusion criteria\n\nStudy participants meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Subject whose medical record is not accessible\n2. Subject who is not willing to provide the informed consent","100 Years",{"count":656,"type":22},278,"Post marketing study on Pluvicto in Korea",[120],[660,78,661,662,663,664],"Metastatic castration-resistant prostate cancer","PMS","RMP","Pluvicto","Korea",{"date":585,"type":53},{"date":667,"type":53},"2025-04-18",{"date":669,"type":22},"2028-05-31",{"name":90,"class":91},11,{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":4,"eligibilityCriteria":678,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":23,"phases":681,"briefSummary":682,"conditions":683,"keywords":696,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":705,"lastUpdatePostDateStruct":706,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":713},"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\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.\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.",{"count":680,"type":22},595,[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.",[684,501,685,686,687,688,689,690,691,120,692,693,39,694,695],"Cancer","Solid Tumor","Locally Advanced Solid Tumor","Metastatic Cancer","WNT Pathway","HCC","Desmoid","Microsatellite Stable Colorectal Cancer","FAP","Endometrial Carcinoma","Microsatellite Instability-High Colorectal Cancer","Adamantinomatous Craniopharyngioma",[684,685,686,687,697,698,699,690,700,701,702,703,704],"WNT Pathway Activating Mutation (WPAM)","Colorectal Cancer (CRC)","Microsatellite Stable (MSS)","Hepatocellular Carcinoma (HCC)","Adenomatous Polyposis Coli (APC)","β-catenin","Beta-catenin","CTNNB1","2026-05-26",{"date":641,"type":53},{"date":708,"type":53},"2023-05-23",{"date":710,"type":22},"2027-08-31",{"name":712,"class":91},"Parabilis Medicines, Inc.",33]