[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b7h3\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b7h3":31},{"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":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100640310","phase-1-a-study-of-225acac-aky-2519-in-patients-with-metastatic-castration-resistant-prostate-cancer-100640310",false,"NCT07581184","A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer","BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer","BActinium-1","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologic or cytologic confirmation of prostatic adenocarcinoma\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Castrate levels of serum testosterone (\\\u003C 50 ng\u002FdL)\n* Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression\n* Cohort B: Received 2 or more prior doses of 177Lu-PSMA-617 (PLUVICTO)\n\nExclusion Criteria:\n\n* Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and\u002For more than 1 taxane-based therapy in the mCRPC setting\n* Prior treatment with a targeted radiotherapy\n\n  o Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)\n* Prior treatment with a B7-H3 targeted therapy\n* Received an investigational agent within the previous 28 days\n* Impaired cardiac function or clinically significant cardiac disease\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity","MALE","18 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \\[64Cu\\]Cu-AKY-2519 and\u002For \\[225Ac\\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \\[225Ac\\]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).",[27,28,29,30,31],"Castration Resistant Metastatic Prostate Cancer","Prostate Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)","mCRPC","B7H3",[33,15,34,35],"AKY-2519","AKY-2519-01","B7-H3","RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-12","ACTUAL",{"date":42,"type":21},"2026-07",{"date":44,"type":21},"2032-06",{"name":46,"class":47},"Aktis Oncology, Inc.","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100551043","early-phase-1-study-on-b7-h3-targeted-affibody-radioligand-probes-for-pet-imaging-of-solid-tumors-100551043","NCT06454955","Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors","Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET","Inclusion Criteria:\n\n1. Age range 18-75 years, open to both male and female participants;\n2. Participants must meet the following hematologic and hepatic\u002Frenal function criteria: Hematology: WBC ≥ 4.0 × 10\\^9\u002FL or neutrophils ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 100 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL; Prothrombin time (PT) or Activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); Hepatic and renal functions: Total bilirubin (T-Bil) ≤ 1.5 times the upper threshold limit (ULT), ALT\u002FAST ≤ 2.5 ULN or ≤ 5 ULT for subjects with liver metastasis, Alkaline phosphatase (ALP) ≤ 2.5 ULN (or ≤ 4.5 ULN in cases of bone or liver metastasis); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;\n3. Normal cardiac function;\n4. Expected survival of at least 12 weeks;\n5. Good adherence to follow-up;\n6. Presence of at least one measurable target lesion according to RECIST 1.1 criteria;\n7. Women of childbearing age (15-49 years) must undergo a pregnancy test within seven days prior to the commencement of the study and test negative; sexually active male and female participants must agree to utilize effective contraception to prevent pregnancy during the study and for three months following the final examination;\n8. Patients for whom a clinical physician recommends PET\u002FCT scans for the diagnosis and staging of tumors;\n9. Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.\n\nExclusion Criteria:\n\n1. Severe abnormalities in liver and renal function and blood counts;\n2. Patients planning to conceive;\n3. Pregnant or lactating women;\n4. Individuals unable to lie flat for thirty minutes;\n5. Individuals who refuse to participate in this clinical study;\n6. Individuals suffering from claustrophobia or other psychiatric disorders;\n7. Other situations deemed unsuitable for trial participation by the researchers.",true,"ALL","75 Years",{"count":59,"type":21},50,[61],"EARLY_PHASE1","Based on \\[68Ga\\]B7H3 Affibody-BCH, this study investigates its radioactive uptake and imaging capabilities in tumor patients, with the aim of establishing a correlation between radioactive uptake and B7-H3 receptor expression. Utilizing whole-body PET technology, the pharmacokinetic dynamics of \\[68Ga\\]B7H3 Affibody-BCH are examined to ascertain its pharmacological characteristics. Ultimately, this research establishes a framework for pharmacokinetic analysis using whole-body PET.",[31,64,65],"CD276 Affibody","PET\u002FCT Imaing","2024-08-21",{"date":68,"type":40},"2024-08-23",{"date":70,"type":40},"2024-01-01",{"date":72,"type":21},"2026-11-30",{"name":74,"class":75},"Peking University Cancer Hospital & Institute","OTHER",1]