[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xiaorong Sun\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,61],{"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":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100619115","early-phase-1-a-prospective-open-label-single-arm-exploratory-clinical-trial-to-evaluate-the-safety-and-tolerability-of-225ac-tr2205-injection-in-patients-with-triple-negative-breast-cancer-100619115",false,"NCT07340424","A Prospective, Open-label, Single-arm, Exploratory Clinical Trial to Evaluate the Safety and Tolerability of 225Ac-TR2205 Injection in Patients With Triple-negative Breast Cancer.","Inclusion Criteria:\n\n1. Voluntary participation in the study and signing of the informed consent form.\n2. Female patients aged 18 years and above.\n3. Patients with triple-negative breast cancer who have been diagnosed by histopathology \\[immune histochemistry estrogen receptor (ER) positive rate \\\u003C 1% is defined as ER negative expression; progesterone receptor (PR) positive rate \\\u003C 1% is defined as PR negative; human epidermal growth factor receptor 2 (HER2) expression 0-1+ or HER2 ++ but fluorescence in situ hybridization\u002Fcolorimetric in situ hybridization (FISH\u002FCISH) negative is defined as HER2 negative expression\\].\n4. Patients with metastatic triple-negative breast cancer who have received at least 2 systemic treatments (at least 1 of which is for metastatic disease).\n5. Patients with at least 1 measurable lesion (tumor evaluation according to RECIST 1.1).\n6. ECOG performance status assessment of 0-1.\n7. Clinical significance of hematological toxicity related to previous treatment must recover to ≤ 2 grade, and non-hematological toxicity ≤ 1 grade (except for hair loss).\n8. For patients with reproductive potential: 7 days before the first administration, fertile women must confirm that the urine pregnancy test is negative and agree to use effective contraceptive measures during the use of the study drug and within 6 months after the last administration (such as oral contraceptives, intrauterine devices, restraint of sexual desire or barrier contraception combined with spermicides, etc.).\n\nExclusion Criteria:\n\n1. Patients who received radiotherapy (except palliative radiotherapy) or chemotherapy, immunotherapy within 3 weeks before treatment, except for bisphosphonates (which can be used for bone metastasis), are excluded.\n2. Patients who received radionuclide therapy within 6 months before enrollment, such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, lutetium-177, actinium-225, or whole-body radiotherapy.\n3. Patients who are undergoing chemotherapy, immunotherapy, biological therapy, off-label radionuclide therapy, or other investigational treatments.\n4. Patients who have undergone major surgery within 28 days before enrollment.\n5. Patients evaluated by the investigator are expected to have a life expectancy of less than 3 months.\n6. Bone scans show super bone imaging, defined as uniform and significant concentration of radioactive isotopes in the entire skeleton relative to soft tissue, while the urinary system is not visible or shows mild visibility.\n7. Symptomatic spinal cord compression, or clinical or imaging evidence suggesting impending spinal cord compression.\n8. Patients with uncontrollable central nervous system (CNS) metastases, who need symptomatic treatment with glucocorticoids or mannitol, and if necessary, enhanced CT or MRI to clarify the status of brain metastases.\n9. Patients with a history of other malignant tumors, except for those with fully treated malignant tumors that have survived without treatment for more than 3 years without recurrence or progression, or patients with fully treated non-melanoma skin cancer and superficial bladder cancer.\n10. Patients with a history that may interfere with the purpose of the study and assessment, or the investigator determines that the patient has any condition that cannot cooperate with imaging examinations, treatment, and procedures.","FEMALE","18 Years",{"count":18,"type":19},15,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","This study is a prospective, single-center, single-arm, open-label research. It evaluates the safety and tolerability of 225Ac-TR2205 in patients with triple-negative breast cancer (TNBC), and assesses its radiation dosimetry and initial efficacy.",[25],"Advanced Metastatic Triple-negative Breast Cancer (mTNBC)","RECRUITING","2026-01-06",{"date":29,"type":30},"2026-01-14","ACTUAL",{"date":32,"type":30},"2025-05-22",{"date":34,"type":19},"2029-05",{"name":36,"class":37},"Xiaorong Sun","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":45,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":38},"100603329","phase-1-a-clinical-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-225acac-psma-xt-injection-in-patients-with-metastatic-castration-resistant-prostate-cancer-100603329","NCT07135102","A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. have the ability to understand and sign an approved informed consent form (ICF).\n2. \\>= 18 years old.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. have a life expectancy \\>6 months.\n5. have histological, pathological, and\u002For cytological confirmation of prostate cancer.\n6. PSMA Positron Emission Tomography (PET)\u002FComputed Tomography (CT) scan positive\n7. have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n8. have received at least one NAAD (such as enzalutamide and\u002For abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.\n9. progressive mCRPC.\n10. have adequate organ function。\n11. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.\n\nExclusion Criteria:\n\n1. Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.\n\n   Known other malignancies.\n2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.\n3. Known hypersensitivity to the components of the study therapy or its analogs.\n4. A superscan as seen in the baseline bone scan.\n5. Patients with a history of Central Nervous System (CNS) metastases.\n6. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.","MALE",{"count":47,"type":19},40,[49],"PHASE1","The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC",[52],"Metastatic Castration-Resistant Prostate Cancer Patients","2025-08-21",{"date":55,"type":30},"2025-08-24",{"date":57,"type":30},"2024-10-14",{"date":59,"type":19},"2027-06-01",{"name":36,"class":37},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":67,"minAge":16,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":20,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":38},"100603331","phase-1-a-clinical-study-of-225acac-fapi-xtxt117-injection-in-patients-with-advanced-solid-tumors-100603331","NCT07135128","A Clinical Study of [225Ac]Ac-FAPI-XT(XT117) Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* ≥18 years old Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 1 Confirmed as malignant solid tumor by histopathology Have measurable lesions based on RECIST 1.1 Have failed standard treatment (disease progression or intolerance) or lack standard treatment Positive FAP expression confirmed by FAP PET\u002FCT Sufficient bone marrow capacity and organ function\n\nExclusion Criteria:\n\n* High intensity and large amounts of off-target uptake by FAP molecular imaging Previous systemic antitumor therapy (including prior chemotherapy, radiotherapy, immunotherapy, and other investigational drugs) ≤28 days before receiving study therapy; previous treatment with Chinese medicine with anti-tumor indications within 2 weeks before receiving study therapy Uncontrolled diabetes, with baseline fasting blood glucose \\> 2×ULN Clinically significant serious cardiovascular disease, including but not limited to: a. \\>Grade II congestive heart failure as per New York Heart Association (NYHA) ; b. Unstable angina pectoris or myocardial infarction within 6 months before the first administration of the study drug; c. Severe arrhythmia within 6 months prior to the first administration; d. Poorly controlled hypertension (patients who keep the blood pressure to ≤ Grade 2 hypertension \\[CTCAE5.0\\] with hypotensor are allowed for enrollment); e. QTc\\>450 ms (male) or 470 ms (female), congenital prolonged QT syndrome, and use of medications that prolong QT Clinically serious thromboembolic disease within 6 months prior to the first administration of the study drug Major surgery within 4 weeks prior to the initial administration of the study drug History of severe gastrointestinal ulcers or perforations or history of intestinal obstruction within 6 months prior to the first administration Active infection requiring systemic treatment (oral or intravenous administration) within 2 weeks prior to the first administration, except for topical treatment History of non-infectious interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis, idiopathic interstitial pneumonia, pneumoconiosis, and drug-related interstitial pneumonia, or severe impairment of lung function Had other malignancies within 5 years prior to screening (except clinically cured early stage malignancies)\n\nPrimary central nervous system (CNS) tumor or symptomatic CNS metastasis, expect:\n\nSubjects with asymptomatic brain metastases; Subjects whose CNS lesions were stable for ≥4 weeks after local treatment and who stopped glucocorticoid or anticonvulsant therapy at least 2 weeks prior to study drug administration could be enrolled; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage","ALL",{"count":69,"type":19},20,[49],"This is a single-center, single-arm clinical study to evaluate the safety, tolerability and preliminary efficacy of \\[225Ac\\]Ac-FAPI-XT injection in patients with FAP-positive advanced solid tumors.",[73],"Advanced Solid Tumor","2025-08-14",{"date":53,"type":30},{"date":57,"type":30},{"date":78,"type":19},"2026-12-01",{"name":36,"class":37},""]