[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor-malignancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor-malignancy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,74,101,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100586139","phase-1-safety-trial-of-68ga177lu-nrt6020-in-fap-positive-advanced-solid-tumor-patients-100586139",false,"NCT06911489","Safety Trial of 68Ga\u002F177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients","A Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of 68Ga-NRT6020 Injection and 177Lu-NRT6020 Injection in FAP-Positive Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female participants aged 18-80;\n2. Histologically or cytologically confirmed advanced solid tumors; advanced solid tumors patients who have failed prior standard therapies or deemed unsuitable for standard therapies (only for stage 2 and stage 3);\n3. Have at least one measurable lesion as per RECIST v1.1\u002FPERCIST criteria;\n4. For stage 2 and stage 3, a positive 68Ga-NRT6020 Injection PET\u002FCT imaging results is required;\n5. Participants must have adequate organ function;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Life expectancy ≥3 months;\n8. For women of childbearing potential, a negative blood pregnancy test within 3 days before the first dose is required, and fertile male and female participants of childbearing potential must agree to use effective contraception with their partners from the signing of the informed consent form until 12 months after the last dose of the investigational drug.\n\nKey Exclusion Criteria:\n\n1. Known allergy to 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection, or any of their ingredients, such as alcohol;\n2. Presence or suspicion of primary central nervous system tumors or intracranial metastasis;\n3. For stage 1: Received prior antitumor treatments within 7 days before the investigational drug dosing, and\u002For plan to receive antitumor treatments during the safety observation period; For stage 2 and stage 3: Received prior antitumor treatments within 4 weeks before the initial investigational drug dosing, including chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc.;\n4. History of other malignancies within 5 years prior to the first dose of the investigational drug, excluding cured non-melanoma skin cancer, early-stage papillary thyroid cancer, and cervical carcinoma in situ;\n5. Presence of severe or uncontrolled cardiac diseases requiring treatment;\n6. High risk of bleeding;\n7. Active syphilis or human immunodeficiency virus (HIV) antibody positive;\n8. HBsAg-positive or HBcAb-positive with HBV-DNA levels above the detection limit;\n9. Failure to alleviate previous antitumor treatment toxicities to Grade 0 or 1 according to CTCAE v5.0;\n10. Participate in any other clinical trials within 1 month before the first dosing of 68Ga-NRT6020 Injection.","ALL","18 Years","80 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Stage 1 (Safety study for 68Ga-NRT6020 Injection):\n\nThe goal of this clinical trial stage is to evaluate the safety of 68Ga-NRT6020 Injection in participants with advanced solid tumors. The study will also assess the biodistribution, radiation dosimetry, imaging profile, and pharmacokinetics of the drug. Additionally, researchers aim to investigate how consistent the PET\u002FCT imaging results of 68Ga-NRT6020 are with 18F-FDG PET\u002FCT imaging and FAP immunohistochemistry (IHC) results.\n\nStage 2 (Safety and tolerability study for 177Lu-NRT6020 Injection):\n\nThis stage focuses on evaluating the safety and tolerability of 177Lu-NRT6020 Injection in FAP-positive participants with advanced solid tumors. Researchers will also assess the safety of 68Ga-NRT6020 Injection in this population. The study will evaluate the biodistribution, radiation dosimetry, pharmacokinetics, and preliminary efficacy of 177Lu-NRT6020 Injection. Additionally, the imaging profile of 68Ga-NRT6020 and its consistency with other imaging techniques will be further investigated.\n\nStage 3 (Preliminary efficacy study for 68Ga\u002F177Lu-NRT6020 Injection):\n\nThe objective of this stage is to evaluate the safety of 177Lu-NRT6020 Injection and 68Ga-NRT6020 Injection in FAP-positive participants with advanced solid tumors, as well as to determine the recommended phase 2 dose (RP2D) of 177Lu-NRT6020 Injection. The study will also assess the preliminary efficacy, biodistribution, radiation dosimetry, and pharmacokinetics of the drugs. Furthermore, researchers will investigate the imaging profile of 68Ga-NRT6020 and its consistency with other imaging techniques.",[27],"Solid Tumor Malignancy",[29,30,31,32],"solid tumor","Radionuclide Drug Conjugates","Companion Diagnostics","FAP","RECRUITING","2026-01-29",{"date":36,"type":37},"2026-02-02","ACTUAL",{"date":39,"type":37},"2025-11-29",{"date":41,"type":21},"2027-12",{"name":43,"class":44},"Chengdu New Radiomedicine Technology Co. LTD.","INDUSTRY",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100591818","phase-1-a-clinical-trial-of-sibp-a18-injection-in-the-treatment-of-advanced-malignant-solid-tumor-patients-100591818","NCT06985368","A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients","A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients","Inclusion Criteria:\n\n* Age range from 18 to 75 years old (including boundary values), regardless of gender.\n* The clinical diagnosis of enrolled participants should meet the following criteria:\n\n  1. Dose escalation and dose expansion stage: Patients with advanced solid tumor diagnosed by histology and\u002For cytology, who have previously failed standard treatment, lack standard treatment regimens, are intolerant to standard treatment, or are currently not eligible for standard treatment.\n  2. Indications expansion stage:\n\nQueue 1: CLDN18.2 positive late stage gastric cancer\u002Fgastroesophageal junction cancer (GC\u002FGEJC) confirmed by histology or cytology with standard treatment failure, intolerance, or no standard treatment.\n\nQueue 2: Late stage CLDN18.2 positive PC confirmed histologically or cytologically with standard treatment failure, intolerance, or no standard treatment.\n\nQueue 3: CLDN18.2 positive late biliary tract cancer (BTC) confirmed histologically or cytologically with standard treatment failure, intolerance, or no standard treatment.\n\n* Willing and able to provide sufficient fresh collected or archived tumor tissue samples within two years.\n* At least one measurable lesion must be selected as the target lesion (according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI)) (for lesions that have previously received radiotherapy, only with clear progression can they be selected as the target lesion).\n* The patient has not previously received any form of topoisomerase I inhibitor in the past, including antibody drug conjugates\n* ECOG score 0-1.\n* Expected survival time ≥ 3 months.\n* During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the investigational drug):\n\nBlood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10\\^9\u002FL, platelet (PLT) count\n\n≥ 90 × 10 9\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL.\n\n* Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective contraceptive measures during the trial period and within 6 months after the last dose.\n* Voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n* Participants with the following tumors:\n\n  * The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ).\n  * The participant has untreated imaging confirmed central nervous system metastasis.\n  * Meningeal metastases.\n  * Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled.\n* Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period:\n\n  * Patients who accepted the instructions clearly containing traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration;\n  * Patients undergoing adjuvant therapy within 6 months after surgery;\n  * Patients who have not recovered from the toxicity of the previous anti-tumor treatment to normal or ≤ level 1 (excluding hair loss);\n  * Patients who have undergone major surgery, radiation therapy, biological therapy, or chemotherapy within 4 weeks prior to their first administration, or who have received systemic treatment such as unhealed surgical wounds, ulcers or fractures, or other clinical trial drugs.\n  * Patients who plan to receive any other anti-tumor treatment (chemotherapy, radiation therapy, immunotherapy, cytokine therapy other than erythropoietin) during the trial period should be excluded (excluding testosterone lowering therapy for prostate cancer patients).\n  * The dose (prednisone\\>10 mg\u002Fd or equivalent) at which immunosuppressive effects are achieved by receiving immunosuppressive agents or systemic corticosteroids within one week prior to the use of the investigational drug.\n* Participants with a history of previous illnesses or laboratory tests that show the following abnormalities:\n\nIndividuals with abnormal coagulation function and a tendency to bleed, or who are undergoing thrombolysis or anticoagulation treatment or have lost blood or donated more than 400 mL within 2 months prior to administration.\n\n* Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n* Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n\n  * Screening period for syphilis spiral antibody positive individuals; Individuals with active hepatitis B virus (HBV) and hepatitis C virus (HCV) infections; Except those with stable hepatitis B (DNA titer below the lower detection limit) and cured hepatitis C (HCV RNA test negative) after drug treatment.\n  * Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serous cavity drainage within 4 weeks before the first administration.\n  * The screening period is accompanied by severe, progressive, or uncontrollable diseases, and the researcher's evaluation determines that the participation of the participants in the study will increase the risk. Including but not limited to:\n* Cerebrovascular accidents or transient ischemic attacks (within the first 6 months of screening); Suffering from heart disease judged by the researcher as unsuitable for participation in this trial, with a severity of cardiac or renal dysfunction ≥ Level II.\n\n  * According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.\n\n    1. Hypertension that cannot be controlled clinically.\n    2. Diabetes with poor drug control.\n    3. Clinically significant thyroid diseases judged by researchers as unsuitable for inclusion.\n    4. Serious infections that occurred within 4 weeks prior to initiating research treatment.\n  * Individuals with a history of severe allergies to protein products, Chinese hamster ovary cell (CHO) cell products, and other recombinant human or humanized antibodies, or to the components of the investigational drug.\n  * Pregnant and lactating women.\n  * Patients deemed unsuitable for inclusion by researchers.","75 Years",{"count":55,"type":21},156,[24],"The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).\n\nA secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18. Evaluate the effect of SIBP-A18 injection on Q to T interval\u002FCorrected QT interval (QT\u002FQTc interval) in participants with advanced solid tumors",[27],[27,60,61,62,63],"ADC","Safety","Efficacy","Pharmacokinetics","2026-01-05",{"date":66,"type":37},"2026-01-07",{"date":68,"type":37},"2025-06-16",{"date":70,"type":21},"2028-09-15",{"name":72,"class":44},"Shanghai Institute Of Biological Products",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100567252","hla-a0201-allele-frequency-and-the-ny-eso-1-expression-status-in-cancer-patients-in-taiwan-100567252","NCT06665776","HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan","A Prospective Observational Human Subject Research to Explore the HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign an informed consent form (ICF).\n2. Adult aged ≥ 18 years at the time of informed consent (or other age required by local regulations).\n3. Confirmed diagnosis of any of the following solid tumor:\n\n   1. Head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma;\n   2. Hepatocellular carcinoma;\n   3. Lung squamous cell carcinoma;\n   4. Synovial sarcoma;\n   5. Triple-negative breast cancer;\n   6. Esophageal squamous cell carcinoma;\n   7. Cervical cancer;\n   8. Ovarian cancer\n4. Patient who received standard curative or palliative therapy including but not limited to any targeted therapy based on mutation status for their cancer, or patient with advanced solid tumors for which there is no accepted therapy, standard therapies are no longer effective, or the patient refuses additional standard therapy.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.\n6. Body weight ≥ 50 Kg.\n7. Life expectancy of ≥ 6 months.\n8. Patient who agrees to provide the tumor sample for NY-ESO-1 IHC staining, from either fresh or archival tissue\n\nExclusion Criteria:\n\n1. Known primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).\n2. Uncontrolled intercurrent illness which is not suitable for enrollment at the discretion of the investigator, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.\n3. Currently confirmed diagnosis of at least 2 active cancers; patient who was cured of the other cancer \\[disease free period \\> 6 months\\] and currently has only one research targeted tumor can be enrolled.\n4. Untreated or symptomatic brain metastasis.\n5. History of organ transplantation or allogeneic stem cell transplantation.\n6. Other conditions (e.g. previous use of any cell therapy) which are not suitable for enrollment at the discretion of the investigator.",{"count":82,"type":21},1200,"1 Day","OBSERVATIONAL","This is a prospective observational research to explore the frequency of Human leukocyte antigen A allele 02:01 (HLA\\*02:01) and the expression status of New York esophageal squamous cell carcinoma-1 (NY-ESO-1) in cancer patients in Taiwanese population.",[27],[88,89,90],"NY-ESO-1","HLA-A*02:01","Solid tumor","2025-07-28",{"date":93,"type":37},"2025-07-30",{"date":95,"type":37},"2023-03-14",{"date":97,"type":21},"2025-12-31",{"name":99,"class":44},"PharmaEssentia",6,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100498285","a-study-for-participants-previously-treated-with-century-therapeutics-cellular-therapy-product-100498285","NCT05768269","A Study for Participants Previously Treated With Century Therapeutics Cellular Therapy Product","A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product","Inclusion Criteria:\n\n* Participant has provided written informed consent prior to any long-term follow-up (LTFU) study-specific procedures.\n* Participants received at least one treatment with a cellular therapy product in an eligible index trial.\n* Participant was withdrawn, early discontinued or completed an eligible index trial.\n* Participant is willing and able to comply with scheduled visits, study plan, and other study procedures.\n\nExclusion Criteria:\n\n-This study has no exclusion criteria.",{"count":109,"type":21},375,"This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.",[112,27],"Hematological Malignancy",[114,115,116,117],"Century Therapeutics","Cellular Therapy","Cell therapy","Malignancy","2025-06-24",{"date":120,"type":37},"2025-06-25",{"date":122,"type":37},"2024-04-29",{"date":124,"type":21},"2040-03",{"name":126,"class":44},"Century Therapeutics, Inc.",7,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":135,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":73},"100573994","clinical-application-of-99mtc-fdph46-spectct-imaging-in-malignant-solid-tumor-a-prospective-exploratory-study-100573994","NCT06753513","Clinical Application of 99mTc-FDPH46 SPECT\u002FCT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study","99mTc；FAPI；mCi","Inclusion Criteria:\n\n1. Patients who are clinically suspected or diagnosed with malignant solid tumors.\n2. Ages between 18 to 80 years old.\n3. Stable vital signs, ECOG score of 0-2, capable of tolerating and cooperating with the 99mTc-FDPH46 SPECT\u002FCT examination.\n4. Subjects who are willing to undergo the 99mTc-FDPH46 SPECT\u002FCT examination and have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Those who can not understand, comply with the research protocol or are unable to sign the informed consent form.\n2. Contraindications for SPECT imaging (including pregnant women, nursing women, women of childbearing age with recent plans to conceive, etc.).\n3. Unstable vital signs, ECOG score \\>2, unable to tolerate or cooperate with the 99mTc-FDPH46 SPECT\u002FCT examination process.",{"count":136,"type":21},20,"The goal of this observational study aims to preliminarily evaluate the diagnostic efficacy of 99mTc-FDPH46 SPECT\u002FCT in malignant solid tumors (compared to the pathological gold standard). The main questions it aims to answer are:\n\n* What is the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors, compared to the pathological gold standard?\n* What is the biodistribution, tumor uptake and safety of 99mTc-FDPH46 SPECT\u002FCT in patients with malignant solid tumors?\n\nParticipant Will:\n\n• Patients with clinically suspected or diagnosed malignant solid tumors who are willing to undergo 99mTc-FDPH46 SPECT\u002FCT examination and sign an informed consent form.",[139,27],"Malignant Tumors",[141,142,143,144],"99mTc","FDPH46","SPECT","Malignant Solid Tumor","NOT_YET_RECRUITING","2024-12-22",{"date":148,"type":37},"2024-12-31",{"date":150,"type":21},"2024-12-28",{"date":152,"type":21},"2026-12-31",{"name":154,"class":155},"Zhejiang University","OTHER"]