[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"castration-resistant-prostatic-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:castration-resistant-prostatic-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,70,113,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100582435","phase-1-a-clinical-study-of-ifinatamab-deruxtecan-based-treatment-combinations-or-as-monotherapy-to-treat-metastatic-castrate-resistant-prostate-cancer-mcrpc-mk-2400-01aideate-prostate02-100582435",false,"NCT06863272","A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A\u002FIDeate-Prostate02)","MK-2400-01A Substudy: A Phase 1\u002F2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening\n* Has current evidence of metastatic disease\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment\n* Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before allocation\u002Frandomization\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation\u002Frandomization\n* Has prior treatment with poly-ADP-ribose polymerase inhibitors (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or has current ILD\u002Fpneumonitis or suspected ILD\u002Fpneumonitis\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Uncontrolled or significant cardiovascular disease\n* History of pituitary dysfunction\n* Poorly controlled diabetes mellitus\n* History or current condition of adrenal insufficiency (eg, Addison's disease)\n* Has received prior treatment with taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC).\n* Chronic steroid treatment (dose of \\>10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma\u002Fchronic obstructive pulmonary disease), topical steroids (for mild skin conditions), or intra-articular steroid injections\n* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* History of allogeneic tissue\u002Fsolid organ transplant","ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about:\n\n* The safety of the study treatment and if people tolerate it.\n* A safe dose level of I-DXd that can be used with other treatments.\n* Participant levels of prostate specific antigen (PSA) during treatment.",[27,28],"Castration-Resistant Prostatic Cancer","Metastasis","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2025-07-03",{"date":37,"type":20},"2031-04-01",{"name":39,"class":40},"Merck Sharp & Dohme LLC","INDUSTRY",82,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100388419","phase-2-fatty-acid-synthase-inhibition-in-castration-refractory-prostate-cancer-100388419","NCT04337580","Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer","A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer","FASN","Inclusion Criteria:\n\n* Patients must have castrate refractory prostate cancer with prior docetaxel treatment which was used in the castrate refractory setting\n* Cancer Progression as defined by prostate cancer working group 3 (PCWG3) any type- prostate specific antigen only, bone only +nodal, nodal only or new lesions\n* Age 18 or older.\n* ECOG 0, 1, or 2\n* Life expectancy of greater than 2 months\n* Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for three (3) months after study treatment discontinuation.\n* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).\n* Organ \\& marrow function as defined below: Absolute neutrophil count \\>1,200\u002FmcL, Platelets \\>75,000\u002FmcL; total bilirubin = within normal institutional limits; AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X institutional upper limit of normal; creatinine \\\u003C2.5 X institutional upper limit of normal\n\nExclusion Criteria:\n\n* Patients may not be receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","MALE",{"count":52,"type":20},50,[24],"The purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition. Investigators believe omeprazole may help the other medications work.",[56,57,58],"Prostate Cancer","Refractory Cancer","Castration Resistant Prostatic Cancer","2026-04-09",{"date":61,"type":33},"2026-04-13",{"date":63,"type":33},"2021-03-05",{"date":65,"type":20},"2028-03",{"name":67,"class":68},"Wake Forest University Health Sciences","OTHER",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":78,"type":20},250,[23],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[82,83,84,85,86,87,88,89,90,91,58,92,93,94,95,96,97,98,99,100,101,102],"Advanced Solid Tumor","Advanced Cancer","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Bladder Cancer","Sarcoma","Endometrial Cancer","Melanoma","Cervical Cancer","Colorectal Cancer","Gastric Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Breast Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)","2026-02-03",{"date":105,"type":33},"2026-02-05",{"date":107,"type":33},"2024-03-06",{"date":109,"type":20},"2028-10",{"name":111,"class":40},"MacroGenics",12,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100479166","phase-1-study-of-janx007-in-subjects-with-metastatic-castration-resistant-prostate-cancer-engager-psma-01-100479166","NCT05519449","Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)","A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Male ≥18 years of age at the time of signing informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible\n* Adequate organ function\n* For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.\n* For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings\n* For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor\n* For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.\n\nExclusion Criteria:\n\n* Prior solid organ transplant\n* Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy\n* Clinically significant cardiovascular disease\n* For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting\n* For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC\n* For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting\n* For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC\n* Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)\n* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment","100 Years",{"count":122,"type":20},272,[23],"This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).",[56,126,58],"Metastatic Castration-resistant Prostate Cancer",[56,128],"Castration-resistant prostate cancer","2026-01-15",{"date":131,"type":33},"2026-01-20",{"date":133,"type":33},"2022-09-15",{"date":135,"type":20},"2028-12",{"name":137,"class":40},"Janux Therapeutics",35,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":69},"100370535","phase-1-the-bispecific-psmaxcd3-antibody-cc-1-in-patients-with-castration-resistant-prostate-carcinoma-100370535","NCT04104607","The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma","First in Human Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma","PSMAxCD3","Inclusion Criteria:\n\nPatients with CRPC will be included in this clinical trial. Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study:\n\n* Existence of a written informed consent\n* Patient is able to understand and comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations\n* CRPC after third line therapy\n* Life expectance of \\> 3 months\n* At least one measurable lesion that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessment\n* Eastern Cooperative Oncology Group Performance (ECOG) Status ≤ 2\n* Patient aged ≥ 18, no upper age limit\n* Male patients with partners of child-bearing potential, who are sexually active, must agree to the use of two highly effective forms of contraception. This should be started from the signing of the informed consent and continue throughout period of taking study treatment for 3 months after last dose of study drug.\n* Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment:\n\n  * Hemoglobin ≥ 10 g\u002Fdl\n  * Neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fμl\n  * Bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * ALT and AST ≤ 2.5 x ULN\n  * Alkaline phosphatase ≤ 2.5 x ULN\n  * PT-INR\u002FPTT ≤ 1.5 x ULN\n  * Creatine kinase ≤ 2.5 x ULN\n  * Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance ≥ 60 ml\u002Fmin\n\nExclusion Criteria:\n\nPatients fulfilling any of the following criteria cannot be enrolled in the trial:\n\n* Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer\n* Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy\n* Persistent toxicity (≥Grade 2 according to Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0) caused by previous cancer therapy, excluding alopecia and neurotoxicity (≤ 2 grade)\n* Clinical signs of active infection (\\>Grade 2 according to CTCAE version 5.0)\n* History of HIV infection\n* Immunocompromised patients\n* Active or chronic viral hepatitis (HBV or HCV)\n* History of autoimmune disease\n* History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) Epilepsy requiring pharmacologic treatment\n* Therapeutic anticoagulation therapy\n* Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.\n* Patients receiving any systemic chemotherapy or radiotherapy within 2 weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used\n* Heart failure NYHA III\u002FIV\n* Severe obstructive or restrictive ventilation disorder\n* Known history of GI-perforation\n* Pre-existing HAHA\n* Known intolerance to CC-1, tocilizumab or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in the respective drug products (CC-1, tocilizumab)",{"count":148,"type":20},86,[23],"This trial is a first in human (FIH) study in patients with castration resistant metastatic prostate cancer (CRPC) after failure of third-line therapy aiming to evaluate safety and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity developed within DKTK. CC-1 binds to human prostate-specific membrane antigen (PSMA) on prostate cancer cells as well as to tumor vessels of CRPC, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format which not only prolongs serum half-life but most importantly reduces off-target T cell activation with expected fewer side effects. Together with preemptive IL-6 receptor (IL-6R) blockade using tocilizumab, this allows for application of effective bsAb doses with expected high anticancer activity. The study comprises two phases. The first phase is a doseescalation phase with concomitant prophylactic application of tocilizumab to evaluate the maximally tolerated dose (MTD) of CC-1. This is followed by a dose-expansion phase (also with prophylactic IL-6R blockade using tocilizumab), as this approach has been shown to be efficient and beneficial for patients. A translational research program comprising, among others, analysis of CC-1 half-life and the induced immune response as well as molecular profiling in liquid biopsies will serve to better define the mode of action of CC-1 and to identify biomarkers for further clinical development.",[27],[153,154,145,155],"PSMA","Resistant Prostate Cancer","CC-1","2024-12-04",{"date":158,"type":33},"2024-12-09",{"date":160,"type":33},"2019-11-15",{"date":162,"type":20},"2025-12-31",{"name":164,"class":68},"University Hospital Tuebingen"]