[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-patients-with-bone-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-patients-with-bone-metastasis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":17,"phases":4,"briefSummary":18,"conditions":19,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":35,"locationsCount":4},"100583143","expanded-access-protocol-for-the-use-of-sl-28-in-the-treatment-of-advanced-solid-tumors-100583143",false,"NCT06872489","Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic solid tumor confirmed by histopathology;\n* Having at least one evaluable or measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n* For patients with relapsed\u002Frefractory neuroblastoma with original diagnosis based on tumor histopathology, Karnofsky or Lansky performance status of ≥ 50%;\n* ECOG Performance Status from 0 or 3;\n* The expected survival time is more than 12 weeks;\n* 2 to 65+ old, gender is not limited;\n* The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;\n* Be able to comply with trial and follow-up procedures;\n* Adequate bone marrow and organ function;\n* Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);\n* Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse)or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug.\n* The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;\n* For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.\n* Immunotherapy: At least 42 days after completing any type of immunotherapy, including immune checkpoint;\n* Radiation therapy: 60 days should have elapsed in the case of completing radiation.\n* Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 7 days prior to SL-28 therapy.\n\nExclusion Criteria:\n\n* Untreated or active primary central nervous system (CNS) tumor or metastasis;\n* Patients diagnosed of having primary and secondary immunodeficiencies;\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Arterial\u002Fvenous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n* Known allergy to any of the agents or their ingredients used in this study;\n* Patients who are on hemodialysis;\n* Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;\n* Patients with untreated positive blood cultures or progressive infections.","ALL","2 Years","EXPANDED_ACCESS","This is an Expanded Access Program (EAP) that will give the participants access to the drug SL-28 before it is approved by the FDA. Participants in this study will have Advanced Solid Tumors who failed to respond to standard therapy (chemotherapy, immunotherapy) or developed progressive disease at any phase of standard therapy.\n\nResearchers think the SL-28 will be effective because SL-28 has a direct activity against different types of tumors.\n\nSL-28 is a cell-based therapy, based on leukocytes isolated from healthy donors and are activated through the proprietary process. After quality assessment (sterility, viable cell count, purity, and absence of infectious diseases), they are stored at -80°C until use. Upon need, the SL-28 is thawed, followed by checking their viability, count, and sterility. Adult and older adult patients aged 18 to 65+ who meet the eligibility criteria will be included in the study. Patients receive SL-28 IV once daily on days 1-5 and 8-12. Based on the patient's response, the need for additional injections will be evaluated. If improvements in the patient's condition are confirmed by MRI, further injections can continue on a rate 5 days a week.",[20,21,22,23,24,25,26,27,28,29],"Neuroblastoma in Children","Neuroblastoma, Recurrent, Refractory","Advanced Cancer","Advanced Malignant Neoplasm","Prostate Cancer Patients With Bone Metastasis","Lung Cancer Non-Small Cell Cancer (NSCLC)","Lung Cancer - Non Small Cell","Gastrointestinal Cancers","Head and Neck Cancer","Pancreatic Cancer","AVAILABLE","2025-07-17",{"date":33,"type":34},"2025-07-23","ACTUAL",{"name":36,"class":37},"Second Life Therapeutics","INDUSTRY",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":45,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100590838","phase-2-treatment-of-patients-with-progressive-mcrpc-with-177lu-psma-617-100590838","NCT06972628","Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617","177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan","Inclusion Criteria:\n\n1. Ability to understand and sign an informed consent form (ICF).\n2. Willingness and ability to comply with study requirements.\n3. Age ≥18 years.\n4. Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP\u002FHDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n6. Hemoglobin ≥9.0 g\u002FdL.\n7. Platelet count ≥90 × 10⁹\u002FL.\n8. White blood cell count ≥2.0 × 10⁹\u002FL, absolute neutrophil count (ANC) \\>1.5 × 10⁹\u002FL.\n\n   o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).\n9. Serum\u002Fplasma creatinine ≤1.5 × upper limit of normal (ULN).\n10. Histological, pathological, or cytological confirmation of prostate cancer.\n11. Positive PSMA PET\u002FCT scan showing at least one PSMA-positive metastatic lesion.\n12. Castrate-level serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n13. Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).\n\nExclusion Criteria:\n\n1. Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.\n2. Prior PSMA-targeted radioligand therapy.\n3. Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.\n4. Known hypersensitivity to PLUVICTO or its components.\n5. Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n6. Renal impairment (estimated glomerular filtration rate \\\u003C60 mL\u002Fmin), hemoglobin \\\u003C9 g\u002FdL, ANC \\\u003C1.5 × 10⁹\u002FL, or platelets \\\u003C 90 × 10⁹\u002FL.\n7. History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.\n8. Symptomatic or impending spinal cord compression.\n9. Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.\n10. Major surgery within 30 days prior to enrollment.\n11. Plans to conceive or father a child during treatment and up to six months post-treatment.","MALE","18 Years",{"count":48,"type":49},30,"ESTIMATED","INTERVENTIONAL",[52],"PHASE2","The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a \"super scan\" pattern on a bone scan.\n\nPluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.\n\nThe study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.\n\nThe safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.\n\nThis study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.",[55,24,56,57,58],"Metastatic Castration-Resistant Prostate Cancer","Prostate Cancer (CRPC)","Prostate Cancer","Prostate Cancer Metastatic",[60,61,62,63,64,65],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","super scan bone scan","Prostate Cancer patients with bone metastasis","prostate cancer (CRPC)","Prostate cancer","Prostate cancer metastatic","RECRUITING","2025-05-12",{"date":69,"type":34},"2025-05-15",{"date":71,"type":49},"2025-05-23",{"date":73,"type":49},"2029-04-01",{"name":75,"class":76},"Ebrahim S Delpassand","OTHER",1]