[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastasis-castration-resistant-prostate-cancermcrpc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastasis-castration-resistant-prostate-cancermcrpc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644944","early-phase-1-response-with-interim-psma-pet-in-metastatic-castration-sensitive-prostate-cancer-for-optimization-of-adaptive-metastasis-directed-radiotherapy-delivery-100644944",false,"NCT07674771","Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery","RIPCORD","Inclusion Criteria:\n\n1. History of pathologically confirmed prostate cancer.\n2. Age \\>=18 years.\n3. Performance status ECOG 0-2.\n4. Staging 68Ga PMSA-11 PET\u002FCT showing 4-20 sites of metastasis from prostate cancer within \\\u003C=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).\n5. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.\n6. All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n7. Ability to understand and the willingness to sign a written informed consent.\n8. Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2).\n\nExclusion Criteria:\n\n1. Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.\n2. Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.\n3. Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.\n4. Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.\n5. History of allergic reactions to PMSA-11 68Ga imaging agent.\n6. Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.","MALE","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.",[26,27,28],"Castrate Sensitive Prostate Cancer","Prostate Cancer","Metastasis Castration Resistant Prostate Cancer(mCRPC)",[30,31,32,33,34],"metastatis","poly-metastatic","prostate cancer","castration sensitive","radiotherapy","NOT_YET_RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":20},"2026-07-15",{"date":43,"type":20},"2029-06-15",{"name":45,"class":46},"University of Texas Southwestern Medical Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100516187","phase-2-artemis-003-hs-20093-in-patients-with-metastatic-castrate-resistant-prostate-cancer-mcrpc-and-advanced-solid-tumors-100516187","NCT06001255","ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors","ARTEMIS-003: A Phase 2, Open-label, Multi-center Study to Evaluate Efficacy, Safety, and Pharmacokinetics, of Intravenous Administration of HS-20093 in Patients With Metastasis Castration Resistant Prostate Cancer and Advanced Solid Tumors Who Have Progressed Following at Least One Prior Therapy","Inclusion Criteria:\n\n* Subjects eligible for inclusion in this study must meet all of the following criteria:\n\n  1. Men or women greater than or equal to 18 years.\n  2. Locally advanced or metastatic solid tumors confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable.\n  3. At least one measurable lesion in accordance with RECIST 1.1.\n  4. Agree to provide fresh archival tumor tissue.\n  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1.\n  6. Estimated life expectancy ≥ 12 weeks.\n  7. Men or women should be using adequate contraceptive measures throughout the study.\n  8. Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.\n  9. Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n* Any of the following would exclude the subject from participation in the study:\n\n  1. Treatment with any of the following:\n\n     Previous or current treatment with B7-H3 targeted therapy. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093.\n\n     Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093.\n\n     Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion.\n\n     Major surgery within 4 weeks prior to the first scheduled dose of HS-20093. Spinal cord compression or brain metastases. Treatment with drugs that are predominantly strong inhibitors or inducers or sensitive substrates of CYP3A4, CYP2D6, P-gp or BCRP with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.\n\n     Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study\n  2. Patients with BRCA and ATM mutation.\n  3. Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity\n  4. History of other primary malignancies.\n  5. Inadequate bone marrow reserve or organ dysfunction.\n  6. Evidence of cardiovascular risk.\n  7. Severe, uncontrolled or active cardiovascular diseases.\n  8. Severe or uncontrolled diabetes, including diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period.\n  9. Severe or poorly controlled hypertension.\n  10. Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093\n  11. Serious arteriovenous thrombosis events occurred within 3 months before the first dose\n  12. Severe infections occurred within 4 weeks before the first dose\n  13. Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation\n  14. The presence of active infectious diseases before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.\n  15. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis\n  16. Other moderate or severe urinary diseases that may interfere with the detection or treatment of drug-related urinary toxicity or may seriously affect urinary function.\n  17. History of serious neuropathy or mental disorders.\n  18. Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n  19. Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093\n  20. History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins\n  21. Hypersensitivity to any ingredient of HS-20093\n  22. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.\n  23. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.","ALL",{"count":57,"type":20},120,[59],"PHASE2","HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer.\n\nThis is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.",[28],"RECRUITING","2024-08-19",{"date":65,"type":39},"2024-08-20",{"date":67,"type":39},"2024-01-18",{"date":69,"type":20},"2025-12-31",{"name":71,"class":72},"Hansoh BioMedical R&D Company","INDUSTRY",15]