[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castration-resistant-prostate-cancer-mcrpc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castration-resistant-prostate-cancer-mcrpc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,45,88,112,136,166,189,220,248,276,301,332,358,379,419,439,464,485,509,546,566,594,615,644,665],{"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":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100630887","phase-1-trial-of-xaluritamig-in-adults-with-metastatic-castration-resistant-prostate-cancer-100630887",false,"NCT07493512","Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer","A Phase 1b, Open-label Study of Xaluritamig (AMG 509) in Adults With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy imaging obtained within 28 days prior to enrollment.\n* Evidence of progressive disease, defined as 1 or more PCWG3 criteria:\n\n  * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL.\n  * Soft tissue progression defined as an increase ≥ 20% and an absolute increase of ≥ 5 mm 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 one 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 scintigraphy (as per the 2+2 PCWG3 criteria).\n* Prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n* Prior progression on at least one androgen receptor pathway inhibitor (androgen receptor pathway inhibitor \\[ARPI\\], enzalutamide, abiraterone, apalutamide, darolutamide).\n* Prior treatment with only one taxane therapy in the mCRPC setting. Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.\n\nExclusion Criteria:\n\n* History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.\n* History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.\n* History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free for \\>3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer.\n* Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.\n* Known positive test for human immunodeficiency virus.\n* Presence or history of viral hepatitis infection.\n* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of trial treatment with the following exceptions:\n\n  * Androgen-deprivation therapy with luteinizing hormone-releasing hormone\u002Fgonadotropin-releasing hormone (LHRH\u002FGnRH) analogue (agonist\u002Fantagonist) is allowed.\n  * ARPIs (enzalutamide, abiraterone, apalutamide, darolutamide) require a minimum washout of 2 weeks prior to the first dose of xaluritamig.\n  * Prior prostate-specific membrane antigen (PSMA) radionuclide therapy cannot be given within 3 months prior to first dose of xaluritamig unless participant received \\\u003C2 cycles of therapy, in which case participant cannot have received PSMA radionuclide therapy within 35 days prior to first dose.\n* Any prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Any prior cluster of differentiation 3 (CD3)-directed therapy.\n* Requirement for chronic systemic corticosteroid therapy (prednisone dose \\>10 mg\u002Fday or equivalent) or any other immunosuppressive therapies (including anti TNFα therapies).\n* Participation on any other xaluritamig trial, regardless of whether xaluritamig was administered.","MALE","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).",[26],"Metastatic Castration-resistant Prostate Cancer (mCRPC)",[28,29,30,31],"Xaluritamig","AMG 509","mCRPC","Prostate Cancer","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2026-04-28",{"date":40,"type":20},"2030-07-30",{"name":42,"class":43},"Amgen","INDUSTRY",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100321141","phase-1-a-study-of-mevrometostat-for-treatment-of-relapsedrefractory-sclc-castration-resistant-prostate-cancer-and-follicular-lymphoma-100321141","NCT03460977","A Study of Mevrometostat for Treatment of Relapsed\u002FRefractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma","A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED\u002FREFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)","Part 1 and Part 2 (Closed for enrollment).\n\nPart 3 Key Inclusion Criteria:\n\n* Histological or cytological diagnosis of castration resistant prostate cancer.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months.\n* Adequate bone marrow, renal, and liver function\n\nPart 3 Key Exclusion Criteria:\n\n* Prior irradiation to \\>25% of the bone marrow.\n* QTcF interval \\>480 msec at screening.\n* Hypertension that cannot be controlled by medications (\\>150\u002F90 mmHg despite optimal medical therapy).\n* Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)\n* Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.\n* Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4\u002F5 inducers or inhibitors\n* Prior enzalutamide within the last 4 weeks\n* DDI SUBSTUDY:\n* history of CHF or evidence of ventricular dysfunction\n* fructose intolerance\n* coadministration of CYP3A4 substrates","ALL",{"count":54,"type":20},453,[23],"The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed\u002F Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.\n\nPart 3, which is open for enrollment is seeking men who:\n\n* have Castration Resistant Prostate Cancer (CRPC) and\n* have previously received treatment for CRPC and have progressed from the last treatment\n\nAll participants in Part 3 of this study will receive mevrometostat and\u002F or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort).\n\nIn the assessment phase:\n\n* participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods.\n* participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and\u002For itraconazole 1 time a day based on a present schedule.\n* participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and\u002For itraconazole 1 time a day based on a present schedule.\n\nAfter completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding.\n\nThe study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.",[58,59,60],"Metastatic Castration Resistant Prostate Cancer (mCRPC)","Small Cell Lung Cancer (SCLC)","Follicular Lymphoma (FL)",[62,63,64,65,30,66,67,68,69,70,71,72,73,74,75,76,77,78],"EZH2","enhancer of zeste homolog 2","castrate resistant prostate cancer","prostatecancer-study.com","efficacy","safety","pharmacokinetics","pharmacodynamics","dose escalation","dose expansion","open-label","small cell lung cancer","SCLC","follicular lymphoma","FL","relapsed","refractory","2026-06-29",{"date":33,"type":36},{"date":82,"type":36},"2018-04-17",{"date":84,"type":20},"2029-07-07",{"name":86,"class":43},"Pfizer",83,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100644694","prolong-prostateolapariboncombinationgcc-study-100644694","NCT07674121","PROLONG (PRostateOLaparibONcombinationGcc) Study","Non-Interventional, Observational, Retrospective and Prospective, Single- Arm Study to Assess the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA Pre-exposed mCRPC Patients in the GCC Region","PROLONG","Inclusion Criteria:\n\n* Adult male patients (age ≥18 years)\n* Documented histopathology or cytopathology of metastatic prostate adenocarcinoma\n* Confirmed castration-resistant status, defined as disease progression despite castrate levels of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL), as demonstrated by radiographic progression, PSA progression, or symptomatic progression\n* Prior exposure to an NHA in earlier settings.\n* Planned or prior initiation of Olaparib + Abiraterone in the 1st line mCRPC setting as per routine clinical practice.\n* Patients who are willing and able to sign an informed consent and are either currently receiving or are planned to initiate Olaparib + Abiraterone per routine clinical practice.\n\nExclusion Criteria:\n\n* -Prior exposure to a Poly (ADP-ribose) Polymerase Inhibitor (PARPi), including Olaparib, Rucaparib, Niraparib, or Talazoparib.\n* Patients who received or progressed on abiraterone in previous lines of treatment before mCRPC diagnosis (e.g., in metastatic hormone-sensitive prostate cancer \\[mHSPC\\]).\n* Participation in an investigational clinical trial with another prostate cancer therapy within 30 days prior to Olaparib initiation.\n* Life expectancy \\\u003C3 months (unrelated to mCRPC) that could interfere with study outcomes\n* Known hypersensitivity to Olaparib, Abiraterone, or their excipients.\n* Uncontrolled medical conditions that may compromise participation or data interpretation, in the opinion of the Investigator (e.g., severe hepatic impairment, active infections).\n* Any psychiatric or cognitive conditions that may interfere with the patient's ability to consent or comply with study procedures.",{"count":97,"type":20},75,"OBSERVATIONAL","The study will generate regionally relevant data to inform clinical practice, support treatment guidelines, and potentially contribute to supportive evidence for health authority discussions or scientific publications. This aligns with AstraZeneca's strategic goal of expanding the real-world evidence (RWE) base for Olaparib in diverse populations and practice settings. The study also complements the strategic priorities and focus areas, as well as strengthening AstraZeneca's leadership position in the management of prostate cancer and establishing the intensification therapy of Poly (ADP-ribose) Polymerase Inhibitor (PARPi) combination in metastatic castration-resistant prostate cancer (mCRPC) with previous exposure to a novel hormonal agent (NHA) for current and future medications (a next-generation PARPi).",[26],[31,102],"Olaparib and Abiraterone","NOT_YET_RECRUITING","2026-06-25",{"date":79,"type":36},{"date":107,"type":20},"2026-06-30",{"date":109,"type":20},"2029-09-30",{"name":111,"class":43},"AstraZeneca",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100360402","phase-1-a-trial-to-find-out-if-regn5678-nezastomig-is-safe-and-how-well-it-works-alone-or-in-combination-with-cemiplimab-for-adult-participants-with-metastatic-castration-resistant-prostate-cancer-and-other-tumors-100360402","NCT03972657","A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors","A Phase 1\u002F2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression","Key Inclusion Criteria:\n\nmCRPC cohorts (men):\n\n1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.\n2. PSA value at screening ≥4 ng\u002FmL that has progressed within 6 months prior to screening as defined in the protocol.\n3. Has received ≥2 lines prior systemic therapy approved in the metastatic and\u002For castration-resistant setting (in addition to Androgen Deprivation Therapy \\[ADT\\]) including at least:\n\n   1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)\n   2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol\n\nccRCC cohorts (men and women):\n\n1. Histologically or cytologically confirmed RCC with a clear-cell component.\n2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria\n3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) \\[PD-1\\]\u002FProgrammed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and\u002For a tyrosine kinase inhibitor\n\nKey Exclusion Criteria:\n\n1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol\n2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol\n3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC\n4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.\n5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol\n6. Any condition that requires ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy\n7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol\n8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency\n\nNOTE: Other protocol defined Inclusion\u002FExclusion Criteria apply",{"count":120,"type":20},345,[23,122],"PHASE2","The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\\[s\\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.\n\nThe study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.\n\nThis study is looking at several other research questions, including:\n\n1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab\n2. How REGN5678 alone or in combination with cemiplimab works in the body\n3. How much REGN5678 and\u002For cemiplimab are present in the blood\n4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor",[125,126],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Clear Cell Renal Cell Carcinoma (ccRCC)","2026-06-22",{"date":104,"type":36},{"date":130,"type":36},"2019-08-12",{"date":132,"type":20},"2027-11-15",{"name":134,"class":43},"Regeneron Pharmaceuticals",22,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\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* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":145,"type":20},1314,[23],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[149,125,150,151,152,153,154,155,126,156],"Renal Cell Carcinoma (RCC)","Urothelial Carcinoma (UC)","Solid Tumor","Hepatocellular Carcinoma (HCC)","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","2026-06-17",{"date":127,"type":36},{"date":160,"type":36},"2021-12-14",{"date":162,"type":20},"2030-06-28",{"name":164,"class":43},"Exelixis",122,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100526585","phase-3-a-study-of-opevesostat-mk-5684-versus-alternative-next-generation-hormonal-agent-nha-in-metastatic-castration-resistant-prostate-cancer-mcrpc-post-one-nha-mk-5684-004-100526585","NCT06136650","A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)","MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease shown by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \\[mHSPC\\] or non-metastatic hormone-sensitive prostate cancer \\[nmHSPC\\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \\[mCRPC\\] or non-metastatic castration-resistant prostate cancer \\[nmCRPC\\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel\n* Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment\n* Has ongoing androgen deprivation therapy (ADT) with serum testosterone \\\u003C50 ng\u002FdL (\\\u003C1.7 nM)\n* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization\n* Has adequate organ function\n* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia\u002Fosteoporosis are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has presence of gastrointestinal condition\n* Is unable to swallow capsules\u002Ftablets\n* Has history of pituitary dysfunction\n* Has poorly controlled diabetes mellitus\n* Has clinically significant abnormal serum potassium or sodium level\n* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \\\u003C110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy\n* Has a history of active or unstable cardio\u002Fcerebrovascular disease, including thromboembolic events\n* History or family history of long QTc syndrome\n* Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment\n* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place\n* Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures\n* Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention\n* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention\n* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat\n* Has a \"superscan\" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* 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 the first dose of study medication\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed\n* Active infection requiring systemic therapy\n* Has concurrent active Hepatitis B virus and Hepatitis C virus infection",{"count":145,"type":20},[175],"PHASE3","The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.",[26,178],"Prostatic Neoplasms","2026-06-05",{"date":181,"type":36},"2026-06-09",{"date":183,"type":36},"2023-12-18",{"date":185,"type":20},"2030-12-02",{"name":187,"class":43},"Merck Sharp & Dohme LLC",329,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100614907","phase-1-ab-3028-a-programmable-circuit-t-cell-therapy-in-patients-with-castration-resistant-prostate-cancer-crpc-100614907","NCT07285694","AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)","An Open-label, Multicenter Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients With Castration Resistant Prostate Cancer (CRPC)","Key Inclusion Criteria:\n\n1. At least 18 years of age at time of signing informed consent form.\n2. Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:\n\n   • Documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on PCWG3 criteria.\n3. Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy.\n\n   • PSMA+ by PSMA PET.\n   * Measurable disease by RECIST 1.1 criteria, or evaluable disease via measurable PSA (≥ 1 ng\u002FmL) per PCWG3 criteria.\n4. Adequate organ functions.\n\nKey Exclusion Criteria:\n\n1. Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.\n2. Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.\n3. Unwillingness to participate in an extended safety monitoring period.",{"count":197,"type":20},190,[23,122],"This is a multi-center, open-label Phase 1\u002F2 trial evaluating the safety and efficacy of AB-3028 in subjects with metastatic castration resistant prostate cancer (mCRPC).",[58],[202,203,204,205,206,207,208,209,210],"prostate cancer","metastatic","Programmable circuit T cell","CRPC","AB-3028","autologous Cell Therapy","Cell Therapy","CAR T","castration resistant","2026-06-03",{"date":179,"type":36},{"date":214,"type":36},"2026-01-09",{"date":216,"type":20},"2031-05",{"name":218,"class":43},"Arsenal Biosciences, Inc.",9,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":227,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":247},"100640868","phase-1-exploring-auger-enhanced-psma-targeted-radioligand-therapy-a-first-in-taiwan-clinical-study-of-161tb-psma-it-100640868","NCT07621692","Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T","Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Age ≥ 20 years, ability to understand and willingness to sign informed consent, cooperate with all study-related procedures and assessments including blood tests and imaging\n2. Histologically confirmed adenocarcinoma of the prostate with evidence of metastatic castration-resistant prostate cancer (mCRPC)\n3. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone analog, with a serum testosterone level \\\u003C50 ng\u002FdL (castrate range)\n4. Prior treated with at least one line of taxane-based chemotherapy unless medically unsuitable, and at least one line of androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide)\n5. Prior treated with 177Lu-labeled PSMA RLT unless medically unsuitable or declined by the patient\n6. Progressive disease defined according to Prostate Cancer Clinical Trials Working Group 3: Either a PSA progression of more than 2 rising PSA values from baseline with intervals ≥ 1 week, or a soft-tissue progression on images per RECIST 1.1 criteria, or a bone progression on images with more than 2 new lesions\n7. Evidence of significant PSMA-avid lesions on 68Ga- or 18F-labeled PSMA PET\u002FCT within 12 weeks prior to screening, which defined as 68Ga-PSMA or 18F-PSMA uptake greater than that of liver or spleen parenchyma (depend on the tracer used) in at least one metastatic lesion of any size in any organ system\n8. A life expectancy of ≥ 6 months and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n9. Adequate bone marrow and organ functions 9.1 Hemoglobin ≥ 10 g\u002FdL without RBC transfusion within 4 weeks 9.2 Absolute neutrophil count ≥ 1.5 × 109\u002FL 9.3 Platelet count ≥ 150 × 109\u002FL 9.4 Creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault) 9.5 AST and ALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN\n10. Willingness to comply with the use of medically acceptable forms of barrier contraception if sexually active\n\nExclusion Criteria:\n\n1. History of allergic reaction to PSMA-targeted compounds or radiometals\n2. Prior radioligand therapy with 223Ra or 177Lu-PSMA within 6 months\n3. Prior surgery or radiotherapy within 4 weeks prior to first investigational dose\n4. Prior systemic therapies against prostate cancer within 4 weeks, including androgen receptor pathway inhibitor, chemotherapy, targeted therapy such as PARP inhibitors (PARPi)\n5. Discordant disease on PET images: FDG-positive disease with minimal PSMA expression\n6. Urinary tract obstruction causing hydronephrosis unless appropriately treated beforehand\n7. Known symptomatic brain metastases or leptomeningeal disease, symptomatic or impending cord compression unless appropriately treated beforehand\n8. Other active malignancy requiring systemic treatment\n9. Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina)\n10. Concurrent severe uncontrolled illness that may jeopardize patient safety, including uncontrolled infections","20 Years",{"count":229,"type":20},12,[23],"This study is a phase I dose escalation clinical trial aims to evaluate 161Tb-PSMA-I\\&T, a new generation prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) using Terbium-161 to replace Lutetium-177, its safety, dosimetry, biodistribution, pharmacokinetics, and preliminary efficacy in Taiwanese men with metastatic castration-resistant prostate cancer, and to inform future clinical trials.",[58],[234,235,236,58],"Radioligand therapy","Terbium-161","Prostate-specific Membrane Antigen (PSMA)","2026-05-29",{"date":239,"type":36},"2026-06-02",{"date":241,"type":36},"2026-01-01",{"date":243,"type":20},"2030-12-31",{"name":245,"class":246},"National Taiwan University Hospital","OTHER",2,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":247},"100636845","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-oral-inr731-single-agent-or-in-combination-with-androgen-receptor-pathway-inhibitor-arpi-in-patients-with-metastatic-prostate-cancer-100636845","NCT07570979","A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer","An Open-label, Multi-center, First in Human Phase I Global Dose Escalation and Expansion Study of INR731 Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer","Inclusion Criteria:\n\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.\n* Participants must have histological and\u002For cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are eligible as long as the non-adenocarcinoma feature is the minority component.\n* At least 1 metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to Cycle 1 Day 1 (C1D1).\n* Patients must have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n* Ongoing androgen deprivation therapy (ADT) either via orchiectomy and\u002For ongoing gonadotropin-releasing hormone (GnRH) analog or inhibitor is allowed.\n* Participants must be mCRPC patients who have either progressed on or are not candidates for other SOC. Prior taxane, poly(ADP) ribose polymerase (PARP) inhibitor, and lutetium Lu 177 vipivotide tetraxetan (Pluvicto) are allowed. Combination expansion patients, however, must be 1L mCRPC with no prior treatment in the mCRPC setting. Treatment within the mHSPC setting does not affect eligibility.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old.\n* Histological and\u002For cytological confirmation of non-adenocarcinoma of the prostate.\n* Patients with biochemical recurrence only or those without evidence of metastatic disease by radiographical imaging (CT\u002FMRI or bone scan) are not eligible.\n* Patients previously treated with a cereblon-based degrader.\n* Patients who are HIV+ or immune compromised.\n* Use of agents known to prolong QT interval unless they can be permanently discontinued for the duration of the study\n* Treatment with an investigational agent within 7 days (or 5 half-lives, whichever is longer) of the anticipated Cycle 1 Day 1 (C1D1).\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":256,"type":20},208,[23],"The purpose of this study is to assess the safety, tolerability, pharmacokinetics\u002Fpharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastatic prostate cancer.",[26],[261,202,30,262,263,264,265,266],"INR731","castration resistance","androgen receptor pathway inhibitor","ARPI","abiraterone","enzalutamide","2026-05-27",{"date":269,"type":36},"2026-05-28",{"date":271,"type":36},"2026-05-25",{"date":273,"type":20},"2030-06-03",{"name":275,"class":43},"Novartis Pharmaceuticals",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100637297","phase-1-regn15505-psmax4-1bb-alone-or-in-combination-with-cemiplimab-or-regn4336-psmaxcd3-in-adult-patients-with-metastatic-castration-resistant-prostate-cancer-and-clear-cell-renal-cell-carcinoma-100637297","NCT07594106","REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma","Phase 1\u002F2 Study of REGN15505 (a PSMAx4-1BB Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN4336 (a PSMAxCD3 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma","Key Inclusion Criteria:\n\nParticipants with mCRPC:\n\n1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma\n2. mCRPC with PSA value at screening ≥4 ng\u002FmL and that has progressed within 6 months prior to screening as described in the protocol\n3. Has received ≥2 lines of prior systemic therapy approved in the metastatic and\u002For castration-resistant setting as described in the protocol\n4. Have had either Orchiectomy or be on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone \\\u003C50 ng\u002FdL AND agree to stay on LHRH agonist or antagonist therapy during the study\n\n   Participants with ccRCC:\n5. Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component\n6. Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria\n7. Has progressed on or after ≥1 line of prior systemic therapy approved in the metastatic setting. Prior treatment must include an Anti Program Cell Death 1 (PD-1)\u002F Program Death Ligand 1 (PD-L1) therapy and either ipilimumab and\u002For a Tyrosine Kinase Inhibitor (TKI)\n\nKey Exclusion Criteria:\n\nFor Both mCRPC and ccRCC Cohorts:\n\n1. Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol\n\n   mCRPC Cohort Only:\n2. Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617)\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":284,"type":20},265,[23,122],"This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells.\n\nThe study will evaluate the use of REGN15505 when administered alone, in combination with cemiplimab, or in combination with REGN4336 for:\n\n* Any side effects of study drugs\n* How well the study drugs work\n* How much REGN15505, cemiplimab, and REGN4336 are in the blood at different times\n* If the body makes antibodies to REGN15505 or REGN4336, which may mean the study drugs will not work as well as expected\n* What is the best dose of REGN15505 when administered alone and with cemiplimab and the best dose of REGN15505 and REGN4336 when used in combination",[125,126],[289,290,291,292,293],"Cemiplimab","PSMA","REGN4336","REGN15505","4-1BB","2026-05-11",{"date":296,"type":36},"2026-05-18",{"date":271,"type":20},{"date":299,"type":20},"2030-09-20",{"name":134,"class":43},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":21,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":331},"100635174","phase-2-cannabidiol-for-pain-relief-of-patients-with-end-stage-mcrpc-100635174","NCT07549256","Cannabidiol for Pain Relief of Patients With End-stage mCRPC","Efficacy and Safety of Cannabidiol for Pain Relief of Patients With End-stage Metastatic Castration Resistant Prostate Cancer - a Randomised Double-blinded Placebo-controlled Phase II Trial","ProCan","Inclusion Criteria:\n\n* Patients diagnosed with mCRPC as documented by increasing PSA despite optimally attempted treatment, and no other therapeutic options.\n* Treatment-resistance or ineligible to standardized cancer therapy, incl. medical and surgical castration, chemotherapy, and super hormone treatment.\n* Minimum 3 months since radiation therapy, if part of treatment.\n* Perception of pain\n* Daily use of Morphine (ATC: N02AA01) (10mgx2) in relief of pain.\n\nExclusion Criteria:\n\n* Perception of worst pain \\\u003C4.0 on the NRS within the last week prior to baseline visit70. (Inclusion if: three days with highest pain intensity have an average of ≥4.0 and\u002For three days where pain intensity is at least 4.0).\n* Pattern of short duration of response to all previous treatment regimens (\\\u003C6 months) clinically assessed by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\>3 (scale 0-5).\n* Change in regular use of conventional pain medication within two weeks prior to baseline visit.\n* A history of substance use disorder.\n* Functional liver insufficiency with an alanine transaminase (ALT) \\>2X ULN and\u002For bilirubin \\>2X ULN assessed by a blood sample taken at screening.\n* Renal failure with an estimated glomerular filtration rate (eGFR) \\\u003C 30mL\u002Fmin\u002F1,73m2 assessed by a blood sample taken at screening.\n* Known heart failure - New York Heart Association III - IV (scale I-IV)71.\n* Known severe chronic obstructive lung disease (Forced Expiratory Volume in the first second (FEV1) \\\u003C50%)72.\n* Use of THC-containing cannabis products measured by a urine sample at screening.\n* Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with compliance or the assessment of efficacy in this trial.\n* Hypersensitivity to the active substance\n* Not capable of giving informed consent.\n* Not capable of understanding, write or read Danish.",{"count":310,"type":20},58,[122],"The goal of this clinical trial is to evaluate the effects of cannabidiol in patients with end-stage metastatic castration-resistant prostate cancer (mCRPC).\n\nThe primary objective is to determine whether cannabidiol (CBD) treatment can reduce the need for opioids in patients with end-stage mCRPC.\n\nAdditionally, the study will assess a range of clinical endpoints in patients with end-stage mCRPC, including:\n\n1. The efficacy of CBD treatment in alleviating pain\n2. The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies\n3. The impact of CBD treatment on physical activity and quality of life\n4. The anti-inflammatory and potential anti-tumor properties of CBD\n5. The safety of CBD treatment\n\nPatients from Department of Urology, Aalborg University Hospital will be included. Participants will be treated with either CBD (200 mg) or placebo (0 mg) three times daily for nine weeks. At baseline, halfway and end of trial, participants will use an activity tracker and complete questionnaires regarding pain and quality of life and provide blood samples to measure inflammation and tumor activity. Also, they will complete a daily dairy regarding the study drug and intake of pain medication. Adverse events will be assessed by Common Terminology Criteria for Adverse Events.",[58],[315,316,317,318,319,320,30],"Cannabidiol","CBD","Prostate cancer","Adjuvant palliative therapy","Cannabis","Metastatic castration resistant prostate cancer","2026-04-17",{"date":323,"type":36},"2026-04-24",{"date":325,"type":20},"2026-06-01",{"date":327,"type":20},"2029-01",{"name":329,"class":330},"Regionshospital Nordjylland","OTHER_GOV",1,{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":341,"briefSummary":342,"conditions":343,"keywords":344,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":331},"100563406","phase-1-green-tea-and-quercetin-in-combination-with-docetaxel-chemotherapy-in-castration-resistant-prostate-cancer-patients-100563406","NCT06615752","Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients","A Phase I\u002FII Study to Determine the Safety and Efficacy of a Combination of Green Tea and Quercetin With Docetaxel in Castration-resistant Prostate Cancer Patients","Inclusion Criteria:\n\n* Signed and dated informed consent form and HIPPA (Health Insurance Portability and Accountability Act) authorization.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male patients 18 years or older\n* Diagnosed with metastatic prostate cancer\n* History of confirmed progressive disease with concurrent use of medical castration (e.g. luteinizing hormone-releasing hormone analogue), or surgical castration\n* Confirmed progressive disease with concurrent use of enzalutamide, apalutamide, darolutamide, and\u002For abiraterone acetate\n* Clinical decision to start doc infusion with prednisone treatment\n* Adequate bone marrow function (absolute neutrophil count (ANC) more than1500 cells\u002Fmm³, platelet count more than 100,000 cells\u002Fmm³)\n* Adequate liver function (total bilirubin less than upper limit of normal (ULN), alanine aminotransferase (ALT) less than 1.5 x ULN, aspartate aminotransferase (AST) less than 1.5 x ULN)\n* Adequate renal function (serum creatinine level within normal limits)\n* At least a 6-month or greater life expectancy\n* Willing to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention\n\nExclusion Criteria:\n\n* Prior treatment of chemotherapy and\u002For radiotherapy for metastatic disease\n* Any comorbid condition that would preclude the administration of docetaxel\u002Fprednisone\n* Ongoing alcohol abuse\n* Significant medical or psychiatric conditions that would make the patient a poor protocol candidate\n* Prior allergic reaction to tea, tea products or quercetin supplements\n* Allergies to multiple food items or nutritional supplements",{"count":340,"type":20},99,[23,122],"The goal of this clinical trial is to find out if taking natural products green tea and quercetin along with docetaxel chemotherapy improves the therapy of advanced prostate cancer, i.e., metastatic castration-resistant prostate cancer (mCRPC). It will also learn about the safety of this combination.\n\nResearchers will compare green tea plus quercetin to a placebo (a look-alike substance that contains no drug) in combination with docetaxel to see if green tea and quercetin works to improve the therapeutic effect of docetaxel.",[26],[345,346,347,202,348],"green tea","quercetin","docetaxel","phase II","2026-04-13",{"date":351,"type":36},"2026-04-15",{"date":353,"type":20},"2026-10",{"date":355,"type":20},"2029-02",{"name":357,"class":246},"Charles Drew University of Medicine and Science",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":331},"100634232","phase-1-3d1015-injection-for-patients-with-mcrpc-100634232","NCT07537010","3D1015 Injection for Patients With mCRPC","Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study","Inclusion Criteria:\n\n1. Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits.\n2. Male, aged 18 years or older.\n3. Histologically or cytologically confirmed prostate adenocarcinoma.\n4. Castrate levels of serum\u002Fplasma testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL).\n5. Must be 68Ga-PSMA PET\u002FCT scan positive.\n6. ECOG performance status of 0 to 2.\n7. Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments.\n8. Presence of at least one metastatic lesion at baseline.\n9. Adequate Organ Function.\n10. Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia).\n\nExclusion Criteria:\n\n1. Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.\n2. Life expectancy of \\\u003C 6 months, as assessed by the investigator.\n3. A superscan as seen in the baseline bone scan.\n4. Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.\n5. Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds.\n6. Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.",{"count":366,"type":20},8,[23],"This open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes. The primary objectives are to assess the safety, tolerability, and dosimetry of the injection. Secondary objectives include evaluating preliminary anti-tumor efficacy and exploring the optimal dosing regimen.",[370],"Metastatic Castration-resistant Prostate Cancer, mCRPC","2026-04-12",{"date":321,"type":36},{"date":374,"type":36},"2025-08-27",{"date":376,"type":20},"2027-12-31",{"name":378,"class":246},"Chunjing Yu",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":389,"briefSummary":390,"conditions":391,"keywords":395,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":418},"100600863","phase-1-a-clinical-study-of-ktx-2001-in-subjects-with-metastatic-castration-resistant-prostate-cancer-strike-001-100600863","NCT07103018","A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)","Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer","STRIKE-001","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n3. Male participants with mCRPC as defined by PCWG3 criteria.\n4. Metastatic disease documented using bone scan for bone metastases (PCWG3 criteria) or by computed tomography (CT) or magnetic resonance imaging (MRI) for soft-tissue metastases. Evidence of metastasis on prostate-specific membrane antigen positron emission tomography alone will not be sufficient for confirmation of metastatic disease.\n5. Willingness to undergo a baseline and on-treatment biopsy of a metastatic site if safe and feasible. If tissue from a biopsy of a metastatic site (including bone) obtained within the previous 6 months (prior to treatment start) is available, this tissue may be used, and the baseline biopsy may be omitted.\n6. Participants should have progressed on or after receiving an ARPI (eg, abiraterone, enzalutamide, darolutamide, or apalutamide).\n7. Adequate renal function (creatinine clearance \\>50 mL\u002Fmin by serum creatinine).\n8. Adequate hepatic function (total bilirubin ≤1.5× ULN, total bilirubin \\\u003C3× ULN for participants with documented Gilbert's syndrome, AST and ALT ≤2.5× ULN). In case of liver metastases, AST and ALT \\\u003C5× ULN is allowed.\n9. Adequate hematological function (neutrophils \\>1 × 109\u002FL, platelet count \\>100 × 109\u002FL, hemoglobin \\>9 g\u002FdL) with no prior transfusions within 2 weeks.\n\nExclusion Criteria:\n\n1. Presence of symptomatic or uncontrolled brain metastases unless adequately treated, not requiring steroids and stable for the last 28 calendar days before signing the ICF. Participants with leptomeningeal disease are excluded without exception.\n2. Symptomatic or impending cord compression that has not been treated or stabilized.\n3. Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as coagulopathy or encephalopathy), or other reasons which, in the investigator's opinion, could compromise the participant's safety or interfere with or compromise the integrity of the study outcomes.\n4. Presence of a drug-related toxicity from prior cancer therapy that has not resolved to Grade ≤1 (with the exception of alopecia and Grade 2 neuropathy) according to NCI-CTCAE Version 5.0.\n5. Active, uncontrolled, bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. In equivocal cases, participants with a negative viral load may be eligible. Eligibility criteria for HIV-positive participants currently on highly active antiretroviral therapy should be evaluated and discussed with the medical monitor and will be based on current and past CD4 and T cell counts, history (if any) of AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment. Participants with previously treated HBV and HCV with negative viral load are eligible.\n6. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect participation in this study.\n\n   1. QT interval corrected by Fridericia's formula \\>470 msec at screening.\n   2. Unstable cardiovascular function defined as:\n   3. Symptomatic ischemia, or\n   4. Uncontrolled clinically significant conduction abnormalities (ie, ventricular tachycardia on antiarrhythmic agents are excluded; first-degree atrioventricular block or asymptomatic left anterior fascicular block\u002Fright bundle branch block are not excluded), or\n   5. Congestive heart failure New York Heart Association Class ≥3, or\n   6. Myocardial infarction within 3 months of the screening visit.\n   7. Hypertension that cannot be controlled (persistent \\>150\u002F90 mmHg despite optimal medical therapy).\n7. Current use or anticipated need for food or drugs that are known strong CYP3A inducers or inhibitors, including their administration within 10 days or 5 half-lives of the CYP3A inhibitor, whichever is longer prior to first dose of study drug.\n8. Treatment with anticancer therapies including radiotherapy or AR-targeted therapy\u002Fandrogen biosynthesis inhibitor) within 2 weeks prior to initial study drug dose or within 4 weeks for systemic chemotherapy, radioligand therapy, or other systemic anticancer therapies.\n9. Treatment with another investigational agent in the 4 weeks prior to the initial dose of study drug.\n10. Major surgical procedures ≤28 days prior to the initial dose of study drug. Participants must have recovered from any of the effects of any major surgery. No waiting period is required following central venous access placement, biopsy collection, or minor surgeries as long as the investigator assesses the impact on study participation.\n11. Initiation of hormonal agents with antitumor activity against prostate cancer including 5alpha reductase inhibitors, androgens (eg, testosterone), cytoproterone acetate, etc during study participation (from the time of consent to off-study); however, stable use of 5-alpha reductase inhibitors is permitted, if continuous use for ≥6 months.\n12. Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (eg, saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc) within 4 weeks of study drug initiation or plans to initiate treatment with these products\u002Falternative therapies at any point during the study.\n\nFor Part B only (KTX-2001 + darolutamide): Current use or anticipated need for drugs that are known as combined P-glycoprotein (P-gp) and strong or moderate CYP3A4 inducers including their administration within 10 days or 5 half-lives of the combined Pgp\u002FCYP3A4 inducer, whichever is longer prior to first dose of darolutamide.",{"count":388,"type":20},144,[23],"Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.",[392,393,370,30,394],"Metastatic Castration-resistant Prostate Cancer","Metastatic Castration-Resistant Prostate Cancer Patients","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[30,396,397,398,66,67,68,69,399,400,401,402,403,178,404,405,406,407,408],"Metastatic Castration-Resistant Prostate Cancer","castration-resistant prostate cancer","NSD2 inhibitor","Darolutamide","NUBEQA","Metastatic Disease","Neoplasms","prostatic Diseases","Urogenital Neoplasms","Neoplasms by Site","Urogenital Diseases","Male Urogenital Diseases","Epigenetics","2026-03-19",{"date":411,"type":36},"2026-03-23",{"date":413,"type":36},"2025-11-21",{"date":415,"type":20},"2028-09",{"name":417,"class":43},"K36 Therapeutics, Inc.",13,{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":21,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":435,"leadSponsor":437,"locationsCount":4},"100616803","phase-1-68ga-psma-0057-and-177lu-psma-0057-in-patients-with-psma-positive-metastatic-castration-resistant-prostate-cancer-100616803","NCT07310355","68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","A Phase I\u002FII, Single-Arm, Open-Label, Dose-Escalation and Expansion Study of 68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Able to communicate well with investigators, understand the study purpose and requirements, voluntarily participate, and sign written informed consent.\n2. Male, ≥18 years at screening.\n3. Histologically or cytologically confirmed prostate cancer (excluding neuroendocrine prostate cancer and small cell prostate cancer), previously treated with at least one novel hormonal agent and 1-2 taxane-based regimens, or deemed intolerant to taxanes.\n4. Serum\u002Fplasma testosterone at castrate level (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n5. Documented progressive mCRPC based on ≥1 of the following: PSA progression (two consecutive PSA rises ≥1 week apart from a minimum value of 2.0 ng\u002FmL); soft tissue progression per PCWG3 and RECIST v1.1; or bone progression with ≥2 new lesions.\n6. PSMA-positive on imaging with 68Ga-PSMA-0057 (within 3 days before treatment start) or other investigator-accepted PSMA tracers (within 6 months before treatment start), using criteria in Section 4.8.5.\n7. At least one measurable lesion per RECIST v1.1 and\u002For at least one bone metastasis per PCWG3.\n8. Estimated life expectancy ≥12 weeks.\n9. ECOG performance status 0-1 at baseline.\n10. Adequate organ and bone marrow function, meeting the following lab criteria:\n\n1)Bone Marrow: Absolute Neutrophil Count (ANC) ≥1.5×109\u002FL, Platelets (PLT) ≥100×109\u002FL, White Blood Cell (WBC) count ≥2.5×109\u002FL, Hemoglobin (HGB) ≥9.0 g\u002FdL (no transfusions\u002Fgrowth factors within 14 days prior to screening).\n\n2)Liver Function: Serum Total Bilirubin (T-Bil) ≤1.5 ULN (unless Gilbert's syndrome); Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≤3 ULN for non-liver metastasis, or ≤5 ULN for liver metastasis.\n\n3)Renal Function: Serum creatinine ≤1.5 ULN, or estimated Glomerular Filtration Rate (eGFR) ≥50 mL\u002Fmin\u002F1.73m2 (calculated using the MDRD formula).\n\n11.Serum albumin concentration ≥30 g\u002FL 12.Toxicities from prior therapies recovered to CTCAE v5.0 Grade 0-1 (alopecia excepted).\n\n13.Men with reproductive potential agree to use highly effective contraception from informed consent through 6 months after last study dose and have no plans to donate sperm.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any study drug component or excipients, or history of specific allergic disease requiring systemic therapy, or other serious allergic reactions.\n2. Prior PSMA-targeted radioligand therapy, or treatment with radionuclides such as Sr-89, Sm-153, Re-186, Re-188, Ra-223, or hemibody radiation within 6 months prior to consent.\n3. Use of any investigational drug or device within 30 days before consent.\n4. Systemic anticancer therapy within 28 days or 5 half-lives prior to consent (whichever is longer), including chemotherapy, radiotherapy, immunotherapy, targeted therapy, systemic immunomodulatory drugs, or antitumor traditional Chinese medicines\u002Fformulations within 2 weeks before first dose.\n5. Another malignancy within the past 5 years, except for curatively treated cervical carcinoma in situ, non-melanoma skin cancers, etc.\n6. Major surgery or significant traumatic injury within 4 weeks before consent.\n7. Active brain metastases or CNS involvement, including untreated symptomatic lesions or those requiring radiation, surgery, or steroids within 1 month prior to screening.\n8. Symptomatic spinal cord compression or clinical\u002Fimaging findings suggestive of impending cord compression.\n9. Severe arterial\u002Fvenous thromboembolic events within 6 months prior to screening; history of stroke; uncontrolled hypertension; decompensated heart failure (NYHA III-IV); LVEF \\\u003C50%; unstable angina; clinically significant arrhythmias requiring intervention.\n10. Significant acute or chronic infections, including active TB, systemic bacterial or fungal infections requiring systemic therapy.\n11. Clinically significant COPD or moderate-severe chronic respiratory disease requiring systemic therapy within 6 months before first dose.\n12. Uncontrolled bladder outlet obstruction or incontinence (patients managed effectively with standard measures are allowed).\n13. Active autoimmune disease requiring systemic treatment within the past 2 years or likely to recur, or active peptic ulcer disease or bleeding disorders.\n14. History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation (corneal transplant recipients not requiring immunosuppressants may be included).\n15. Syphilis, HIV infection, HCV (HCV antibody positive with detectable HCV RNA), or active HBV infection (HBsAg positive with HBV DNA ≥ULN).\n16. Contraindications to PET-CT or SPECT-CT imaging, or factors deemed by the investigator to preclude adequate imaging acquisition and interpretation.\n17. Any condition judged by the investigator likely to interfere with compliance or study participation, or impair the ability to give informed consent.",{"count":427,"type":20},49,[23,122],"This is a single-arm, open-label, Phase I\u002FII clinical study designed to evaluate the safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary efficacy of Gallium \\[68Ga\\] PSMA-0057 Injection and Lutetium \\[177Lu\\] PSMA-0057 Injection as an integrated theranostic regimen in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The study consists of a Phase I dose-escalation phase to determine the maximum tolerated dose (MTD) and\u002For recommended Phase II dose (RP2D) of 177Lu-PSMA-0057, followed by a Phase II dose-expansion phase to further evaluate preliminary antitumor efficacy and confirm safety and pharmacologic profiles. Eligible participants will receive 68Ga-PSMA-0057 for PET imaging and 177Lu-PSMA-0057 for radioligand therapy. Key objectives include characterization of safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary therapeutic activity.",[26],"2025-12-15",{"date":433,"type":36},"2025-12-30",{"date":433,"type":20},{"date":436,"type":20},"2030-04-30",{"name":438,"class":43},"Chengdu StarRay Therapeutics Co., Ltd",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":21,"phases":448,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":247},"100525822","phase-1-combination-study-of-antibiotics-with-enzalutamide-promize-100525822","NCT06126731","Combination Study of Antibiotics With Enzalutamide (PROMIZE)","PROMIZE: A Phase I\u002FII Trial to Assess the Safety, Tolerability and Preliminary Anti-tumour Activity of Oral Combination Antibiotic Therapy to Modulate the Microbiome in Combination With Enzalutamide With Metastatic Castration Resistant Prostate Cancer (mCRPC).","Inclusion Criteria:\n\n1. Histologically or cytologically proven metastatic castration-resistant prostate cancer or adenocarcinoma refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.\n2. Documented prostate cancer progression as assessed by the investigator with RECIST (v1.1) and PCWG3 criteria with at least one of the following criteria:\n\n   1. Progression of soft tissue\u002Fvisceral disease by RECIST (v1.1) and\u002For,\n   2. Progression of bone disease by PCWG3 bone scan criteria and\u002For,\n   3. Progression of PSA by PCWG3 PSA criteria and\u002For\n   4. Clinical progression with worsening pain and need for palliative radiotherapy for bone metastases.\n3. Phase I: Patients that have progressed after at least 12 weeks of treatment with a NAAT within the previous 6 months Phase II: Patients that have progressed after at least 12 weeks of treatment with a NAAT within the previous 6 months (for combination treatment) or more than 6 months prior to trial entry (for enzalutamide alone resistance run-in).\n4. Previously progressed on at least one line of taxane chemotherapy (or not fit or not willing to receive a taxane).\n5. Ongoing androgen deprivation maintaining serum testosterone of less than 50 ng\u002FdL (less than 2.0 nM) is mandatory.\n6. Life expectancy of at least 12-weeks.\n7. Able to swallow tablets.\n8. Archival tumour tissue must be available for analyses.\n9. Willing to have pre- and post-treatment biopsies if biopsy is feasible.\n10. World Health Organisation (WHO) performance status of 0-2 (Appendix 1).\n11. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP.\n\n    Haemoglobin (Hb): ≥ 9.0 g\u002FdL\n\n    Absolute neutrophil count: ≥ 1.5 x 109\u002FL\n\n    Platelet count: ≥ 75 x 109\u002FL\n\n    Serum bilirubin: ≤ 1.5 x upper limit of normal (ULN)\n\n    Alanine aminotransferase (ALT): ≤ 2.5 x (ULN) unless raised due to tumour in which case up to 5 x ULN is permissible\n\n    Aspartate aminotransferase (AST): ≤ 2.5 x (ULN) unless raised due to tumour in which case up to 5 x ULN is permissible\n\n    Serum creatinine \u002F calculated creatinine clearance: ≤ 1.5 x upper limit of normal (ULN) \u002F GFR ≥ 50 mL\u002Fmin (uncorrected value)\n\n    Serum albumin: \\>25 g\u002FL\n12. 18 years or over\n13. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up\n14. Willing and able to comply with the study requirement including the collection of blood, fresh tumour biopsy, urine, rectal swab and stool samples.\n\nExclusion criteria:\n\n1. Surgery, radiotherapy, chemotherapy, or other anti-cancer therapy within 4-weeks prior to trial entry into the study (6 weeks for bicalutamide). The use of bisphosphonates or RANK ligand inhibitors in patients with known osteopenia or osteoporosis or bone metastases is permitted. Prior antiandrogenic treatment exclusions as follows:\n\n   * Patients receiving enzalutamide immediately preceding the trial will be able to continue on enzalutamide without washout.\n   * Prior flutamide treatment during previous 4-weeks. N.B. Patients whose PSA did not decline in response to antiandrogens given as a second line or later intervention will only require a 14-day washout;\n   * Prior bicalutamide (Casodex) and nilutimide (Nilandron) treatment during previous 6-weeks;\n   * Prior progesterone, medroxyprogesterone, progestins, cyproterone acetate, tamoxifen, and 5-alpha reductase inhibitors during previous 2-weeks (14-days).\n2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient.\n3. Previous treatment with any systemic antibiotic within 12 weeks of study entry.\n4. Known hypersensitivity reaction or intolerance to any penicillin, amoxicillin, metronidazole, vancomycin, ciprofloxacin or enzalutamide.\n5. History of tendon disorder secondary to quinolones\n6. Use of drugs that are listed in the prohibited concomitant medications section including strong inducers and inhibitors of CYP450 (please refer to http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002Ftable.aspx). Seville orange or grapefruit products and any herbal medications should be avoided for 4 weeks prior to starting trial treatment.\n7. Concurrent treatment with prohibited medications which include medications that causes ototoxicity, neurotoxicity, and nephrotoxicity.\n8. Known or suspected leptomeningeal metastases or untreated brain metastasis. Patients with brain metastases that have been treated and have been shown to be radiologically stable for more than 6 months may be considered for the trial.\n9. History of stroke, epilepsy or current excessive alcohol intake. History of clinically significant hearing loss including but not limited to congenital hearing loss, need for hearing aids, ongoing acute or chronic ear infection, history of tympanic membrane perforation, tinnitus, vertigo, Meniere disease, cerebrovascular ischemia.\n10. History of clinically significant hearing loss including but not limited to congenital hearing loss, need for hearing aids, ongoing acute or chronic ear infection, history of tympanic membrane perforation, tinnitus, vertigo, Meniere disease, cerebrovascular ischemia.\n11. Patients with partners of child-bearing potential (unless they agree to use a barrier method of contraception \\[condom plus spermicide\\] or to sexual abstinence effective from the first administration of any of the investigational agents, throughout the trial and for 6 months afterwards. Patients with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.\n\n    NB. Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n12. Any condition that would increase enteral absorption in the opinion of the investigator, including but not limited to malabsorption syndromes, impaired GI motility, chronic pancreatitis, partial or complete gastric and\u002For bowel resections, history of clinically significant gastrointestinal bleeding in the last 6 months, history of mesenteric ischemia or bowel obstruction, chronic diarrhoea (≥Grade 2), inflammatory bowel disease (Crohn's disease, ulcerative colitis).\n13. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n14. Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis.\n15. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n16. Any of the following cardiac criteria:\n\n    * Clinically important abnormalities including rhythm, conduction or ECG changes (left bundle branch block, third degree heart block).\n    * Factors predisposing to QT prolongation including congenital long QT syndrome; family history of prolonged QT syndrome, unexplained sudden death (under 40); concomitant medications known to prolong QT interval.\n    * Concurrent congestive heart failure, prior history of class III\u002F IV cardiac disease (New York Heart Association \\[NYHA\\] - refer to Appendix 5), prior history of cardiac ischaemia or prior history of cardiac arrhythmia.\n    * QTcF (corrected using Fredericia formula) of ≥460 ms.\n17. Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.\n18. Active or uncontrolled autoimmune disease requiring corticosteroid therapy or other forms of systemic immunosuppression.\n19. Patient is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.\n20. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.\n21. Malignancy other than prostate cancer within 3-years of trial entry with the exception of adequately treated basal cell carcinoma. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy must have no evidence of that disease for at least-3 years and be deemed at negligible risk for recurrence, are deemed eligible.\n22. Symptoms of COVID-19 and\u002For current documented COVID-19 infection.",{"count":447,"type":20},39,[23,122],"PROMIZE is an open-label, multi-centre, single-arm, Phase I\u002FII clinical trial, evaluating the safety, tolerability and anti-tumuor efficacy of an antibiotic combination and enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).",[125],[452,453,454],"Microbiome","Antibiotic","Enzalutamide","2025-11-19",{"date":457,"type":36},"2025-11-24",{"date":459,"type":36},"2023-11-02",{"date":461,"type":20},"2027-06-30",{"name":463,"class":246},"Institute of Cancer Research, United Kingdom",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":16,"minAge":471,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":21,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":4},"100611731","phase-1-lutetium-177lu-dgul-combined-with-pembrolizumab-in-metastatic-castration-resistant-prostate-cancer-100611731","NCT07244393","Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Lutetium (177Lu) DGUL in Combination With Pembrolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (IGNITE Trial)","Inclusion Criteria:\n\n* Male patients aged 19 years or older.\n* Patients with histopathologically or cytologically confirmed adenocarcinoma of the prostate, without neuroendocrine or small cell differentiation, who have metastatic disease documented by bone lesions\u002Fsoft tissue lesions and are not eligible for curative treatment.\n* Patients with serum testosterone levels meeting castration levels (\\\u003C 50 ng\u002FdL) at the screening visit.\n* Patients must have experienced disease progression following treatment for mCRPC with a second-generation androgen receptor signaling inhibitor therapy (e.g., abiraterone or enzalutamide).\n* Docetaxel treatment is allowed for localised prostate cancer and at mHSPC stage if more than 12 months have elapsed from the last dose of docetaxel, as long as no signs of failure or disease progression occurred during or immediately after such treatment.\n* Patients must be receiving hormone deprivation therapy limited to the use of LHRH agonists or LHRH antagonists throughout the study. For patients who have not undergone bilateral orchiectomy, medical castration with an LHRH agonist or antagonist must have been initiated at least 4 weeks prior to baseline and must be maintained for the entire study duration.\n* Patients with prostate specific membrane antigen (PSMA)-positive disease, with a maximum standardized uptake value (SUVmax) of at least 20 at a site of disease and greater than 10 at other disease sites measuring ≥ 10mm in longest diameter.\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.\n* Patients with a life expectancy of at least 6 months.\n* Patients with adequate hematologic, renal, and liver function, confirmed by the following criteria:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002FμL (without granulocyte colony stimulating factor (G-CSF) administration within 2 weeks prior to baseline)\n  * Platelet count ≥ 100,000\u002FμL (without transfusion within 2 weeks prior to baseline)\n  * Hemoglobin ≥ 9.0 g\u002FdL (without transfusion within 4 weeks prior to baseline)\n  * Serum creatinine ≤ 1.8 mg\u002FdL or Cockcroft-Gault creatinine clearance (CrCl) formula \\> 40 ml\u002Fmin\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5 times the ULN for patients with confirmed liver metastasis\n  * Total bilirubin ≤ 1.5 times ULN (except in patients with Gilbert syndrome)\n  * Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN\n* Patients who have AEs due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline. Patients with endocrine-related AEs who are adequately treated with hormone replacement or patients who have ≤ Grade 2 neuropathy are eligible.\n* Patients who voluntarily agree to participate in the clinical trial and sign the informed consent form.\n\nExclusion Criteria:\n\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years (Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded).\n* Patients who have received chemotherapy, biological therapy, or immunotherapy for prostate cancer within 4 weeks from baseline (6 weeks in the case of nitrosoureas or mitomycin).\n* Any prior treatment with taxane chemotherapy for mCRPC.\n* Patients with history of allogeneic stem cell transplantation (alloSCT), or solid organ transplantation.\n* Patients who have received high-dose chemotherapy requiring hematopoietic stem cell treatment, within 2 years from baseline.\n* Patients who have previously received PSMA-targeted treatment (e.g., radiotherapy, immunotherapy, or antibody-drug conjugate) or those treated with radiopharmaceuticals such as radium-223 within 6 months from baseline.\n* Patients who have previously received radiotherapy (RT) to the lung \\> 30 Gy within 6 months of the first dose.\n* Prior exposure to any anti-programmed cell death protein 1(PD-1), anti-programmed death ligand 1\u002F2 (PD-L1\u002FL2), or anti- cytotoxic T lymphocyte antigen-4 (CTLA-4) antibody, or any other agent specifically targeting T cell co-stimulation or immune checkpoint pathways.\n* 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 the first dose of study intervention.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may enroll if they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks, as confirmed by repeat imaging during the study screening. They must also be clinically stable and must not have required steroid treatment for at least 4 weeks before receiving the first dose of the study intervention.\n* Patients with the following medical history or history of surgery\u002Fprocedures:\n\n  * Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year from baseline.\n  * Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection within 6 months from baseline.\n  * Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months from baseline.\n  * Major cerebrovascular disease, such as stroke, within 6 months from baseline.\n  * General anesthesia or major surgery requiring respiratory assistance within 4 weeks from baseline (video-assisted thoracoscopic surgery or open-and-closed (ONC) surgery allowed within 2 weeks).\n  * Active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid).\n  * History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Patients with the following conditions:\n\nClass III or IV heart failure according to the New York Heart Association (NYHA) classification.\n\n* Uncontrolled hypertension (systolic blood pressure (SBP) \\> 160 mm Hg or diastolic blood pressure (DBP) \\> 90 mm Hg).\n* Clinically significant cardiovascular abnormalities as determined by the investigator (e.g., Left ventricular ejection fraction (LVEF) \\\u003C 50%, clinically significant heart wall abnormalities, myocardial injury or QT interval corrected by Fridericia's formula (QTcF) \\> 450 msec for males or \\> 460 msec for females).\n* Uncontrolled cardiac arrhythmia.\n* Known positive human immunodeficiency virus (HIV) test or other uncontrolled active infectious diseases (e.g., Hepatitis B\u002FC).\n* Myelodysplastic syndrome (MDS).\n* Clinically significant urinary obstruction or hydronephrosis that may affect renal function as determined by the investigator.\n\n  * Patients receiving nephrotoxic drugs (e.g., aminoglycosides).\n  * Patients with severe claustrophobia not controlled by anxiolytics.\n  * Patients with hypersensitivity to any components of the investigational product (IP)s.\n  * Patients unwilling to use appropriate contraceptive methods or abstain from intercourse during the clinical trial and for at least 4 months after discontinuation of the IPs if the patient's partner is capable of childbearing, or who do not agree to refrain from sperm donation during this period.\n  * Patients who have received other IPs or undergone procedures involving investigational medical devices within 4 weeks from baseline.\n  * Any other conditions deemed by the investigator as making the patient ineligible for clinical trial participation.","19 Years",{"count":473,"type":20},30,[23],"The goal of this clinical trial is to evaluate the safety of the combination therapy of Lutetium (177Lu) DGUL and pembrolizumab. It will also assess the antitumor efficacy and pharmacokinetics of the combination therapy compared to Lutetium (177Lu) DGUL monotherapy.\n\nParticipants will:\n\nMonotherapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals\n\nCombination therapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals along with pembrolizumab up to 18 times at 6-week intervals",[26],"2025-11-17",{"date":457,"type":36},{"date":480,"type":20},"2025-12",{"date":482,"type":20},"2029-04",{"name":484,"class":43},"Cellbion Co., Ltd.",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":494,"briefSummary":495,"conditions":496,"keywords":498,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":4},"100605613","phase-2-memantine-hydrochloride-in-prostate-cancer-patients-100605613","NCT07164794","Memantine Hydrochloride in Prostate Cancer Patients","A Prospective Study of Memantine Hydrochloride for the Treatment of Prostate Cancer Patients","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed one or two prior lines of therapy. Patients with concomitant Alzheimer's disease will be prioritized for enrollment.\n3. Complete clinical baseline data must be available, and the patient must be willing to undergo long-term follow-up.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nExclusion Criteria:\n\n1. Patients with metastatic prostate cancer at initial diagnosis who have not progressed to mCRPC.\n2. Patients with a concurrent primary malignancy at another site.",{"count":493,"type":20},15,[122],"The goal of this clinical trial is to learn if long-term use of memantine hydrochloride can treat, prevent, or correct castration resistance and drug resistance in advanced prostate cancer. The study will enroll male patients aged 18 and older diagnosed with metastatic castration-resistant prostate cancer (mCRPC) who have previously failed first or second-line treatments. The main questions it aims to answer are:\n\nWhat is the progression-free survival (PFS) in patients treated with memantine hydrochloride? What is the disease control rate (DCR) and what is the change in Prostate-Specific Antigen (PSA) levels after treatment?\n\nResearchers will compare outcomes from participants in this single-arm study to an external historical control group of patients who received traditional treatment to see if the addition of memantine hydrochloride improves prognosis.\n\nParticipants will be asked to do the following:\n\nContinue their standard of care treatment, which includes Androgen Deprivation Therapy (ADT) and a novel endocrine therapy.\n\nTake the study drug, memantine hydrochloride, with the dose gradually increasing over the first three weeks to a maintenance dose.\n\nAttend regular follow-up appointments for blood tests to check PSA levels and undergo imaging scans to monitor the disease status. These follow-ups will occur one month after starting the drug and every three months thereafter.",[26,31,497],"Neuroendocrine Prostate Cancer (NEPC)",[499,30,500],"Memantine","Prospective Study","2025-11-15",{"date":455,"type":36},{"date":504,"type":20},"2025-11",{"date":506,"type":20},"2028-06",{"name":508,"class":246},"Bin Xu",{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":21,"phases":517,"briefSummary":518,"conditions":519,"keywords":532,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":545},"100447533","phase-1-a-study-of-nx-1607-in-adults-with-advanced-malignancies-100447533","NCT05107674","A Study of NX-1607 in Adults With Advanced Malignancies","A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Measurable disease per disease-specific response criteria.\n* Patients must have disease that is metastatic or unresectable and have received standard treatment options, are not candidates for standard treatment options, or will otherwise be prevented from receiving any standard treatment options.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Minimum of 3 weeks or 5 half-lives (whichever is shorter) since last dose of systemic cancer therapy (unless otherwise specified) or minimum of 2 weeks since last radiotherapy, or minimum of 6 weeks since last systemic therapy with nitrosoureas, antibody-drug conjugate, or radio immuno-conjugate therapy.\n* Adequate organ and bone marrow function, in the absence of growth factors (with limited exception for DLBCL), as defined by laboratory parameters.\n* Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol.\n* Patient must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.\n* Each patient must sign an informed consent form (ICF).\n* Histological or cytological diagnosis of platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; gastric\u002FGEJ cancer; HNSCC; recurrent and either metastatic or unresectable melanoma; NSCLC; mCRPC; MPM; TNBC; locally advanced or metastatic urothelial cancer; cervical cancer; MSS CRC; or DLBCL (including DLBCL-RT)\n* Accessible tumor (for all cohorts) or lymph node (DLBCL only) for biopsy (Phase 1b only).\n\nKey Exclusion Criteria:\n\n* Active untreated brain metastases.\n* Patient has any of the following:\n* Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or ongoing active infection requiring systemic therapy.\n* Patients with primary refractory EOC defined as patients who do not respond to their first platinum-containing regimen or who relapse less than 6 months after completion of that first platinum-containing regimen\n* Psychiatric illness that would limit compliance with study requirements.\n* Treatment with any of the following prior to the first dose of NX-1607: CPI (anti-PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, etc) within 3 weeks; autologous or allogeneic stem cell transplant within 100 days; prior systemic cancer therapy within 3 weeks or 5 half-lives (whichever is shorter) (unless otherwise specified) (including hormonal therapy except for hormonal prophylaxis for a prior malignancy); prior radiotherapy within 2 weeks; prior systemic therapy with nitrosoureas, antibody-drug conjugate, or radio-immuno-conjugate therapy within 6 weeks; use of strong or moderate CYP3A4 inducers or inhibitors within 14 days or 7 days, respectively, or 5 half-lives (whichever is longer)\n* History of CAR-T therapy within 30 days prior to the first dose of NX-1607.\n* Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for Grade 2 alopecia and Grade 2 peripheral neuropathy or patients receiving endocrine replacement therapy\n* Patients who experienced Grade 3 or higher irAEs with prior immunotherapy.\n* History of uveitis, or an 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) is not considered a form of systemic treatment and is allowed.\n* Unable to swallow capsules or has malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction likely to interfere with the delivery, absorption, or metabolism of NX-1607.\n* Known allergies, hypersensitivity, or intolerance to components of NX-1607.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of NX-1607.\n* Patient is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of NX-1607 and, as applicable, within 6 months after the last dose of paclitaxel.\n* Patient has had major surgery (e.g., requiring general anesthesia) within 4 weeks before the planned first dose of NX-1607, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 4 weeks after the last dose of NX-1607. Note: Patients with minor planned surgical procedures to be conducted under local anesthesia may participate.\n* Vaccinated with a live vaccine within 28 days (with the exception of the annual inactivated influenza vaccine) or COVID-19 vaccination within 14 days prior to the first dose of NX-1607.\n* Active known second malignancy with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer.\n  * Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years.\n  * Low-risk prostate cancer with Gleason score \\\u003C 7 and PSA \\\u003C 10 ng\u002FmL.\n  * Any other cancer from which the patient has been disease-free for ≥ 2 years.\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients with well controlled HIV (e.g., CD4 \\> 350\u002Fmm3 and undetectable viral load) are eligible.\n* Current active hepatitis, including hepatitis A (hepatitis A virus immunoglobulin M \\[IgM\\] positive), hepatitis B (hepatitis B virus \\[HBV\\] surface antigen positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV RNA). Patients with HCV with undetectable virus after treatment are eligible. Patients with prior exposure to HBV may be entered if quantitative PCR is negative.\n* Use of systemic corticosteroids (\\> 20 mg prednisone or equivalent) within 15 days (except for prophylaxis for radio diagnostic contrast reactions and\u002For prophylaxis for patients receiving paclitaxel), or other immunosuppressive drugs within 30 days, prior to the first dose of NX-1607.\n* Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg \\[NIH 2020\\] (Note: Patients who switch from a high dose to a dose of 30 µg\u002Fday or less at least 1 day prior to Screening assessments are eligible for study entry).\n* Receipt of an IP or has been treated with an investigational device within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NX-1607.\n* Any of the following within 6 months prior to the first dose of NX-1607 or ongoing:\n\n  * Myocardial infarction\n  * Unstable angina\n  * Unstable symptomatic ischemic heart disease\n  * New York Heart Association Class III or IV heart failure\n  * Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events)\n  * Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease)\n  * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator in consultation with the Medical Monitor.",{"count":120,"type":20},[23],"This is a first-in-human Phase 1a\u002F1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.",[520,521,522,523,524,153,26,525,526,527,528,529,530,531],"Ovarian Cancer, Epithelial","Gastric Cancer","GastroEsophageal Junction (GEJ) Cancer","Head and Neck Squamous Cell Carcinoma","Metastatic or Unresectable Melanoma","Malignant Pleural Mesothelioma (MPM)","Triple Negative Breast Cancer (TNBC)","Metastatic Urothelial Carcinoma","Cervical Cancer","Diffuse Large B Cell Lymphoma (DLBCL)","Richter Transformation","Microsatellite Stable Colorectal Carcinoma",[533,534,535],"Ubiquitin Ligase Inhibitor","Advanced Malignancies","T-cell Activation","2025-09-05",{"date":538,"type":36},"2025-09-09",{"date":540,"type":36},"2021-09-29",{"date":542,"type":20},"2028-02-28",{"name":544,"class":43},"Nurix Therapeutics, Inc.",17,{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":21,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":563,"locationsCount":565},"100534670","phase-2-a-phase-ii-study-to-evaluate-the-safety-efficacy-and-pharmacokinetics-of-yl201-in-patients-with-mcrpc-100534670","NCT06241846","A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC","A Multicenter, Open-Label, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.\n2. Age ≥ 18 years.\n3. Patients should meet the following conditions to be enrolled:\n\n   * Histologically or cytologically confirmed prostate cancer. Note: The primary histological classification indicated by biopsy should be adenocarcinoma;\n   * Meeting the following criteria for clinical diagnosis of mCRPC:\n\n\u003C!-- -->\n\n1. Subjects who understand relevant information of the study prior to initiation of the study and voluntarily sign and date on the ICF.\n2. Age ≥ 18 years.\n3. Patients should meet the following conditions to be enrolled:\n\n   • Histologically or cytologically confirmed prostate cancer. Note: The primary histological classification indicated by biopsy should be adenocarcinoma;\n\n   • Meeting the following criteria for clinical diagnosis of mCRPC:\n\n   √Testosterone level after castration (a serum testosterone level of \\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL);\n   * Serum prostate specific antigen (PSA) progression (PSA \\> 1 ng\u002FmL and 2 consecutive increases in PSA with at least a 1-week interval \\>50% from baseline), or PD by imaging (≥ 2 new bone lesions suggested by a bone scan according to PCWG3 criteria; and\u002For progression of soft tissue lesions suggested by computed tomography (CT) or nuclear magnetic resonance imaging (MRI) according to RECIST v1.1); meeting either or both criteria;\n   * Persistent luteinizing hormone-releasing hormone (LHRH) analogue castration (medical castration) or prior bilateral orchiectomy (surgical castration); surgical castration should be performed at least 3 months prior to enrollment, and medical castration is required from at least 3 months prior to the first dose and throughout the study for subjects not yet undertake bilateral orchiectomy; • Patients with progression on or intolerance to at least one prior novel hormone therapy (NHT) (e.g., enzalutamide, abiraterone, darolutamide, apalutamide, or rezvilutamide); • Prior therapy with no more than 2 lines of chemotherapy is allowed; • Patients with known previous prostate adenocarcinoma with a documented BRCA1\u002F2 (germline or somatic) mutation should have received poly ADP ribose polymerase (PARP) inhibitor therapy (if available and tolerated);\n4. Patients with metastatic lesions confirmed by CT, MRI, or bone scan imaging within 28 days prior to the first dose.\n5. Patients with archived or fresh tumor tissue samples. Patients who cannot provide tumor samples or cannot provide sufficient samples may be enrolled in this study after considering specific circumstances and discussions with the Sponsor.\n\n   • Fresh tumor tissue samples (formalin-fixed, paraffin-embedded (FFPE) tumor blocks or FFPE sections) should be provided for retrospective detection of B7H3 expression by the central laboratory using the immunohistochemistry \\[IHC\\] method; if fresh tumor tissue samples are not available, FFPE tumor blocks previously archived are acceptable, and fresh FFPE sections should be prepared within 2 weeks.\n6. Eastern cooperative oncology group performance status (ECOG PS) score of 0 or 1.\n7. The function of organs and bone marrow meets the requirements within 7 days prior to the first dose, which is defined as follows:\n\n   • Hemoglobin (Hb) ≥ 90 g\u002FL (no blood transfusion or erythropoietin treatment within 14 days prior to the first dose);\n\n   • Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL (no treatment with granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor within 14 days prior to the first dose);\n\n   • Platelet count (PLT) ≥ 100×109\u002FL (no platelet transfusion, thrombopoietin, or interleukin-11 within 14 days prior to the first dose);\n\n   • Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN) in the absence of obvious liver metastasis, or ≤ 3×ULN in the presence of liver metastasis;\n\n   • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN in the absence of obvious liver metastasis or ≤ 5×ULN in the presence of liver metastasis;\n\n   • Serum albumin (ALB) ≥ 30 g\u002FL;\n\n   • Creatinine clearance calculated using Cockcroft-Gault formula ≥ 50 mL\u002Fmin or the creatinine ≤ 1.5×ULN;\n   * Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN, except for patients who are on anticoagulant therapy. In this case, a stable anticoagulant regimen should be maintained with APTT and INR controlled within the range deemed appropriate by the investigator.\n8. Patients must agree to adopt highly effective contraceptive measures from screening, throughout the study period, and within at least 6 months after the last dose of the investigational drug.\n9. Expected survival ≥ 6 months.\n10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.\n\nExclusion Criteria:\n\n1. Previously treated with drugs targeting B7H3.\n2. Currently participating in another clinical study, unless it is an observational (non-interventional) clinical study, or the patient is at the follow-up period of an interventional study.\n3. Previously treated with topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.\n4. The washout period of the previous anti-tumor therapy is considered insufficient.\n5. Patients received major surgery.\n6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.\n7. Prior treatment with glucocorticoids for more than 28 consecutive days within 28 days prior to the first dose of the investigational drug.\n8. Patients received any live vaccine within 4 weeks prior to the first dose of the investigational drug, or plan to receive live vaccine during the study period.\n9. Have pathological long bone fracture, or the risk of pathological long bone fracture.\n10. Have meningeal metastasis or cancerous meningitis.\n11. Have uncontrolled bladder outlet obstruction or urinary incontinence.\n12. Have brain metastasis or spinal cord compression.\n13. Patients with uncontrolled or clinically significant cardiovascular diseases.\n14. Clinically significant complicated pulmonary disorders.\n15. Diagnosed with Gilbert's syndrome.\n16. Accompanying uncontrolled effusion in the third space requiring repeated drainage.\n17. Medical history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may cause hemorrhage or perforation in the opinion of the investigator.\n18. Active serious infection (National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] ≥ 3) within 4 weeks prior to the first dose.\n19. Known human immunodeficiency virus (HIV) infection.\n20. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n21. Diagnosed with the other malignancies that may change the expected survival or affect the response evaluation.\n22. Unresolved toxicity of previous anti-tumor therapy.\n23. History of severe hypersensitivity to inactive ingredients in the drug substance and drug product or other monoclonal antibodies.\n24. Have any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the subject ability to sign the ICF, adversely affect the subject ability to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance\u002Falcohol abuse, in the opinion of the investigator.",{"count":554,"type":20},100,[122],"This is a multicenter, open-label, phase II study of YL201 in China to evaluate the efficacy, safety, and PK characteristics of YL201 on mCRPC.",[26],"2025-08-25",{"date":374,"type":36},{"date":561,"type":36},"2024-02-22",{"date":355,"type":20},{"name":564,"class":43},"MediLink Therapeutics (Suzhou) Co., Ltd.",24,{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":21,"phases":576,"briefSummary":577,"conditions":578,"keywords":579,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":593},"100526399","phase-2-metastatic-castrate-resistant-prostate-cancer-subjects-treated-with-provenge--one-infusion-of-sipuleucel-t-100526399","NCT06134232","Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T","An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response","ProvONE","Inclusion Criteria:\n\nFor a subject to be eligible for participation in this study, all of the following criteria must be satisfied:\n\n1. Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \\[hormone refractory\\] prostate cancer).\n2. Have qualified for on-label PROVENGE® infusion\n3. Have received all 3 infusions of PROVENGE® prior to randomization\n4. Written informed consent provided prior to the initiation of study procedures\n5. Estimated life expectancy ≥12 months\n\nExclusion Criteria:\n\nA subject will not be eligible for participation in this study if any of the following criteria apply.\n\n1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \\[hormone refractory\\] prostate cancer).\n2. Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)\n3. Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.\n4. On experimental or investigational therapy.",{"count":575,"type":20},400,[122],"A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).",[125],[580,581,582,583,584],"Single Dose","Sipuleucel-T","Immune Response Rate","Safety","Adenocarcinoma of the Prostate","2025-08-20",{"date":374,"type":36},{"date":588,"type":36},"2023-10-02",{"date":590,"type":20},"2032-06-30",{"name":592,"class":43},"Dendreon",31,{"id":595,"slug":596,"hasResults":11,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":21,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":331},"100600986","phase-1-study-of-ty-302-capsules-combined-with-abiraterone-in-patients-with-metastatic-castration-resistant-prostate-cancermcrpc-100600986","NCT07104617","Study of TY-302 Capsules Combined With Abiraterone in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC）","A Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of Oral TY-302 Capsules Combined With Abiratone Acetate Tablets in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC) That Has Failed Novel Endocrine Therapy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Metastatic castration-resistant prostate adenocarcinoma confirmed by pathology (with no neuroendocrine or small cell features indicated by the initial pathological examination), if pathological examination is performed in the subsequent CRPC stage, the accompanying other pathological types should not exceed 10%. Those with only pelvic lymph node metastasis or local recurrent metastasis (such as in the bladder, rectum, etc.) cannot be included.\n3. Testosterone levels ≤50ng\u002FdL (≤1.75nmol\u002FL) within 28 days prior to the first administration. If the patient has not undergone bilateral orchiectomy in the past, they must be undergoing and voluntarily continue to receive LHRH agonists\u002Fantagonists for androgen deprivation therapy throughout the study treatment period\n4. During screening, if the disease progresses, that is, the subject experiences one or more of the following three conditions; PSA progression is defined as no PSA \\> 1ng\u002Fml and at least two elevated PSA levels with an interval of ≥1 week. ② Disease progression as defined in RECIST 1.1; ③ Bone disease progression as defined by the PCWG3 standard refers to the discovery of ≥2 new lesions on bone scans.\n5. Previous anti-tumor treatment must meet the following requirements: having failed in only one approved and marketed novel endocrine therapy in the past (referring to disease progression during the process of novel endocrine therapy; The definition of disease progression is the same as that of inclusion criterion 4), such as enzalutamide, apatamide, darotamide or rivelutamide, etc., and no previous treatment with abiraterone acetate has been received.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and life expectancy \\> 3 months.\n7. Have good organ functions, including:\n\n   Liver function: Total bilirubin (TBIL) ≤ 1.5×ULN (except for documented Gilbert syndrome), alanine aminotransferase (ALT) ≤ 2.5×ULN, and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, ALT\u002FAST≤5×ULN), albumin ≥3.0g\u002FL; Renal function: Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance rate ≥50 mL\u002Fmin (calculated according to the Cockcroft and Gault formula); Blood routine: PLT ≥ 100×109\u002FL, ANC ≥ 1.5×109\u002FL, WBC≥ 3.5×109\u002FL and Hb ≥ 90g\u002FL; The international normalized ratio (INR) is ≤1.5, and the activated partial prothrombin time (APTT) is ≤1.5×ULN (in the absence of anticoagulation therapy).\n8. agrees to maintain abstinence (control heterosexual sexual intercourse) or take contraceptive measures, and agrees not to donate sperm\n9. Be able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).\n\nExclusion Criteria:\n\n1. Patients with the following treatment:\n\n   1. Received CDK4\u002F6 inhibitors (e.g., Palbociclib, Ribociclib, Abemaciclib, Trilaciclib\u002FG1T38, SHR6390, pirociclib) ;\n   2. Received abirone acetate tablets and their analogues (CYP17 inhibitors, such as ketoconazole, etc.) or two or more novel endocrine therapies for prostate cancer;\n   3. Received with strontium-89, samarium or radium-223 within 12 weeks prior to the first administration;\n   4. Received systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) within 4 weeks prior to the first medication;\n   5. Received traditional Chinese medicine preparations with anti-tumor therapeutic effects within one week before the first administration, or those who have received nitrourea or mitomycin treatment within six weeks before the first administration;\n   6. Received blood transfusion, albumin infusion or used hematopoietic growth factor within 2 weeks before the first administration;\n   7. Within two weeks prior to the first administration, the patient has received treatment with drugs prohibited by the protocol \\[such as CYP3A strong suppressors, CYP3A strong inducers, and CYP3A-sensitive substrates with a narrow therapeutic index, etc.\\];\n   8. Major surgery was performed within 28 days before the first administration of the drug , or surgery was performed when the surgical effect had not yet recovered at the time of screening or during the planned enrollment for treatment;\n   9. Has received allogeneic transplants such as stem cell transplantation, bone marrow transplantation or liver transplantation in the past;\n   10. Palliative radiotherapy was received within 2 weeks before the first administration;\n   11. The first administration was within no more than five half-lives from the implantation of radioactive particles.\n2. In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding other malignant tumors that have been cured by radical treatment for at least 5 years;\n3. There is previous evidence indicating the existence of homologous recombination gene mutations (such as BRCA1, BRCA2, etc.)\n4. Known to be allergic to any excipients of TY-302 Capsules, or to Abiraterone acetate tablets and their excipients;\n5. There are contraindications for the use of prednisone (corticosteroid), such as active infection, active peptic ulcer, recent gastrointestinal anastomosis surgery, fracture, wound healing period, corneal ulcer, severe osteoporosis or other conditions. Or there may be diseases that require treatment with systemic steroid hormones (i.e., other corticosteroids at a physiological dose of more than 10mg\u002F day, such as prednisone or similar drugs);\n6. Patients whose progression of bone and soft tissue lesions cannot be evaluated, that is, those who meet both of the following criteria simultaneously:\n\n   1. The bone scan showed a super bone imaging;\n   2. According to RECIST1.1 criteria, there were no assessable soft tissue lesions (measurable or unmeasurable).\n7. The patient has any unstable or other disease or medical condition that may affect its safety or compliance with the study, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg), uncontrolled diabetes, active bleeding, ocular lesions Other serious diseases of the mental, nervous and other systems;\n8. Clinically obvious digestive tract abnormalities during screening may affect drug intake, transport or absorption (such as dysphagia, uncontrollable nausea and vomiting, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, etc.);\n9. Severe bone injury caused by tumor bone metastasis, with pathological fractures of important parts or spinal cord compression expected to occur in the near future within 6 months prior to knowledge;\n10. There is cancerous meningitis or untreated central nervous system metastasis. Those who have previously received systemic or radical treatment for brain metastases (radiotherapy or surgery), and whose stability has been maintained for at least one month as confirmed by imaging, and who have stopped systemic hormone therapy (with a dose greater than 10mg\u002F day prednisone or other equivalent dose hormones) for more than two weeks and have no clinical symptoms, can be included;\n11. Patients with clinically symptomatic third space effusion (such as pleural effusion, ascites, pericardial effusion) who require puncture and drainage, or those who have received puncture and drainage within 2 weeks before randomization or the first medication;\n12. At the time of screening, the toxicity of previous treatments had not yet recovered. According to CTCAE v5.0, there were still grade ≥2 AES (excluding special toxicities such as alopecia, fatigue, increased GGT, and increased ALP);\n13. Have severe cardiovascular diseases, including but not limited to:\n\n    1. At rest, a 12-lead electrocardiogram (ECG) examination showed that the QTcF was ≥470ms;\n    2. There are severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;\n    3. Acute coronary syndrome, congestive heart failure (New York Heart Association (NYHA)) cardiac function grade ≥2, aortic dissection or other grade 3 cardiovascular events occurred within 6 months before the first administration;\n    4. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n14. There is a history of thromboembolism or cerebrovascular events within 6 months before the first administration, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis or pulmonary embolism, etc;\n15. There was evidence of radiation pneumonitis, interstitial lung disease or interstitial pneumonia (ILD) requiring hormone therapy during the screening period, or drug-induced ILD, or any active ILD (such as acute exacerbation or progressive pneumonia\u002Fpulmonary fibrosis at baseline). Or pulmonary symptoms that the researchers consider unsuitable for enrollment, or high-risk factors that make it unsuitable for enrollment due to the possibility of interstitial lung disease;\n16. There was a severe infection within 4 weeks before the first administration, including but not limited to bacteremia requiring hospitalization and severe pneumonia; There was an active infection of CTCAE grade ≥2 that required systemic antibiotic treatment within 2 weeks before the first administration (except for local chronic infections or prophylactic antibiotic use that the investigator determined did not require treatment);\n17. Those with a history of active pulmonary tuberculosis infection within 6 months prior to the first administration;\n18. People infected with active human immunodeficiency virus (HIV), syphilis, hepatitis C virus (HCV) or hepatitis B virus (HBV). Active HBV, HCV and HIV infections are defined as:\n\n    1. positive HBsAg and HBV DNA ≥500cps\u002Fml\u002FHBV DNA ≥1000u\u002Fml;\n    2. Anti-hcv antibody and HCV RNA positive;\n    3. HIV antibody positive.\n19. Known history of alcohol or drug abuse or dependence; Mental disorder; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make the participants unsuitable for this study (such as not meeting the most beneficial treatment for the subjects, subject compliance, etc.).",{"count":602,"type":20},48,[23,122],"This study is to evaluate the safety, and preliminary antitumor activity of TY-302 combined with Abiraterone tablets in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy",[26],"2025-07-29",{"date":608,"type":36},"2025-08-05",{"date":610,"type":20},"2025-08",{"date":612,"type":20},"2026-11",{"name":614,"class":43},"TYK Medicines, Inc",{"id":616,"slug":617,"hasResults":11,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":21,"phases":625,"briefSummary":626,"conditions":627,"keywords":629,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":643},"100355122","phase-3-probio-a-biomarker-driven-study-in-patients-with-metastatic-prostate-cancer-100355122","NCT03903835","ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer","ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer","ProBio","Inclusion Criteria:\n\n* Man with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing newly diagnosed (i.e. de novo) hormone sensitive prostate cancer (mHSPC) or first-line castration resistant prostate cancer (mCRPC)\n* Distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI\n* Adequate health as assessed by the investigator to receive all available treatments in the trial\n* ECOG\u002FWHO (Eastern Cooperative Oncology Group\u002F World Health Organization) performance score 0-2\n* Adequate organ and bone marrow function\n* Albumin greater than or equal to 28 g\u002FL\n* Able to understand the patient information and sign written informed consent\n\nExclusion Criteria:\n\n* Other malignancies within 5 years except non-melanoma skin cancer\n* Within 6 months of randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA (transient ischemic attack), or congestive heart failure NYHA (New York Heart Association) class III or IV\n* Uncontrolled hypertension\n* Uncontrolled hypotension\n* Received systemic therapy (with the exception of standard ADT) prior to study inclusion, for the CRPC indication\n* Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results\n* Unable to comply with study procedures\n* Current participation in another clinical trial that will be in conflict with the present study, administration of an investigational therapeutic or invasive surgical procedure within 28 days prior to study enrolment\n* Patients who are unlikely to comply with the protocol\n* Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subjects participation in this study.\n* Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease.",{"count":624,"type":20},750,[175],"ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer. Patients will be randomized to control or experimental treatment arms. Patients in the control arm will receive standard of care following national guidelines. Patients in the experimental arm will be randomized to treatments based on a biomarker signature inferred from diagnostic tissue or liquid biopsy profiling. The predefined biomarker signatures are tumor properties or mutations in genes\u002Fpathways with previously demonstrated clinical validity (e.g. prognostic value or association with treatment response). The biomarker signatures are identified using a hybridisation capture gene panel specifically designed for prostate cancer.",[26,628],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)",[30,630,631,632,633],"mHSPC","cfDNA","Genomics","Liquid Biopsy","2025-04-07",{"date":636,"type":36},"2025-04-09",{"date":638,"type":36},"2019-02-01",{"date":640,"type":20},"2026-12",{"name":642,"class":246},"Karolinska Institutet",32,{"id":645,"slug":646,"hasResults":11,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":21,"phases":652,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":4},"100584552","phase-2-a-study-to-investigate-efficacy-and-safety-of-different-dose-regimen-of-oral-cabazitaxel-tablet-in-adult-participants-with-prostate-cancer-100584552","NCT06890832","A Study to Investigate Efficacy and Safety of Different Dose Regimen of Oral Cabazitaxel Tablet in Adult Participants with Prostate Cancer","A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen","Inclusion Criteria:\n\n1. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study.\n2. Male participant ≥18 years of age at the time of signing the informed consent.\n3. Participant must have histological pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate.\n4. Evidence of metastatic disease.\n5. Participant must be previously treated with a docetaxel-containing regimen (at least 3 cycles) for the treatment of prostate cancer (including locally confined inoperable disease that cannot be treated with definitive intent) and\u002For CRPC. Docetaxel administration in combination with androgen deprivation therapy (ADT) with or without next-generation AR-targeted therapy (abiraterone acetate, enzalutamide, or and next generation targeted agents Darolutamide, apalutamide) in metastatic hormone-sensitive disease is considered a prior docetaxel exposure.\n6. Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration.\n7. Participant must be taking ADT with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤1.73 nmol\u002FL (50 ng\u002FdL) at the screening visit.\n8. Participant must be eligible for treatment with cabazitaxel per the locally approved prescribing information.\n9. ECOG PS grade of 0-2. ECOG PS 2 must be related to prostate cancer, not to other comorbidities.\n10. Estimated life expectancy of ≥6 months as assessed by the investigator.\n11. Participant has recovered from AEs (baseline or ≤ CTCAE Grade 1) due to prior anticancer therapy, unless AE(s) is either clinically nonsignificant or stable on supportive therapy or do not constitute a safety risk to the participant as determined by the investigator.\n12. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last dose of study intervention:\n\n    * Must agree not to plan to father a child or donate sperm for the purpose of reproduction. PLUS, either of the following:\n    * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR\n    * Must agree to use contraception \u002Fbarrier\n13. Participant with adequate hematologic, liver and renal function.\n14. Willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\nExclusion Criteria:\n\n1. Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components\u002F excipients thereof (refer to the IB), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.\n2. Contraindications to the use of prednisone or medical ADT per locally approved prescribing information.\n3. Previous treatment with cabazitaxel in any setting.\n4. Had major surgical procedure or significant traumatic injury requiring general anaesthesia within 4 weeks or will not have fully recovered from surgical procedure prior to first dose of the study intervention; or has surgical procedure planned during the time the participant is expected to participate in the study.\n5. Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to \\>30% of bone marrow within 3 months prior to Baseline.\n6. Symptomatic peripheral neuropathy Grade ≥2 (National Cancer Institute Common Terminology Criteria \\[NCI CTCAE\\] v.5.0).\n7. Presence of hepatitis B surface antigen (HbsAg) at screening or within 3 months prior to first dose of investigational intervention.\n8. Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.\n9. Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.\n10. History of malignancy (except for prostate cancer) within the past 5 years except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy.\n11. • Current or chronic history of liver disease. This includes \\[but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator.\n\n    • Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n12. Participant with clinically significant current or recent (within the past 3 months before randomization \\[unless otherwise specified below\\]) cardiac conditions.\n13. Known active CNS disease, except for treated stable asymptomatic CNS metastases.\n14. Known Leptomeningeal disease.\n15. Unmanageable concurrent bladder outflow obstruction or urinary incontinence.\n16. Has an active infection requiring systemic therapy.\n17. Spinal cord compression not definitively treated with surgical procedure and\u002For radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥4 weeks prior to Baseline.\n18. Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer.\n19. Unable to swallow solid, oral dosage forms whole with the aid of water (participants cannot chew, divide, dissolve, or crush the investigational intervention) or and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication.\n20. Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.",{"count":97,"type":20},[122],"A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.\n\nThe study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.\n\nKey efficacy assessments include CT scans\u002FMRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.\n\nPharmacokinetic parameters will also be evaluated.",[655],"Metastatic Castration-resistant Prostate Cancer, MCRPC","2025-03-17",{"date":658,"type":36},"2025-03-24",{"date":660,"type":20},"2025-05",{"date":662,"type":20},"2027-06",{"name":664,"class":43},"Jina Pharmaceuticals Inc.",{"id":666,"slug":667,"hasResults":11,"nctId":668,"briefTitle":669,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":21,"phases":672,"briefSummary":673,"conditions":674,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":4},"100579652","phase-1-study-on-the-safety-tolerability-and-preliminary-efficacy-of-161tb-nym032-in-patients-with-metastatic-castration-resistant-prostate-cancer-100579652","NCT06827080","Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer","\\*\\*1. Inclusion Criteria\\*\\*\n\n1. The participant voluntarily signs the informed consent form and is able to complete the trial according to the protocol requirements.\n2. Male, aged 18 years or older.\n3. Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) as per PCWG3 criteria.\n4. Positive results on 68Ga-NYM032 positron emission tomography (PET)\u002Fcomputed tomography (CT) scan.\n5. Must have received at least one NAAD treatment (e.g., enzalutamide and\u002For abiraterone) or at least one taxane-based treatment regimen, or be intolerant to or refuse taxane therapy for metastatic castration-resistant prostate cancer.\n6. ECOG performance status of 0-2.\n7. Expected survival of ≥6 months.\n8. Laboratory parameters must meet the following:\n\n   1. ALT and AST must not exceed 3 times the upper limit of normal (ULN); BUN and Cr must not exceed 1.5 times the ULN.\n   2. Blood counts: WBC ≥3.5×10\\^9\u002FL, PLT ≥100×10\\^9\u002FL, Hb ≥90 g\u002FL.",{"count":493,"type":20},[23,122],"161Tb-NYM032 is a radiopharmaceutical labeled with a PSMA ligand, used for the treatment of metastatic castration-resistant prostate cancer, which is needed for clinical trial to be conducted.",[655,675],"Cancer","2025-02-10",{"date":678,"type":36},"2025-02-14",{"date":680,"type":20},"2025-02-11",{"date":682,"type":20},"2026-12-01",{"name":684,"class":246},"Zhengguo Chen"]