[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extrapulmonary-neuroendocrine-carcinoma-ep-nec\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extrapulmonary-neuroendocrine-carcinoma-ep-nec":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,88,113,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100649739","phase-2-iparomlimab-and-tuvonralimab-ql1706-plus-lenvatinib-and-chemotherapy-for-extrapulmonary-neuroendocrine-carcinoma-100649739",false,"NCT07738159","Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine Carcinoma","A Prospective, Randomized, Controlled Clinical Trial of Iparomlimab and Tuvonralimab Injection (QL1706) Plus Lenvatinib and Chemotherapy as First-Line Treatment for Extrapulmonary Neuroendocrine Carcinoma","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed locally advanced unresectable or metastatic extrapulmonary neuroendocrine carcinoma. Eligible primary sites include the gastrointestinal tract, pancreas, biliary tract, and other extrapulmonary organs. Neuroendocrine carcinoma of the digestive system must be diagnosed according to the 2019 World Health Organization Classification of Tumours of the Digestive System.\n2. Age ≥18 years, with no restriction on sex.\n3. Life expectancy of at least 12 weeks.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n5. Patients must not have received prior first-line systemic anticancer therapy for advanced or metastatic disease. Patients who previously received adjuvant therapy following curative surgery are eligible, provided that disease recurrence occurred more than 6 months after completion of adjuvant therapy.\n6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).\n7. No severe complications related to the primary tumor, including perforation, obstruction, or major bleeding that cannot be adequately controlled with medical treatment.\n8. Adequate organ function, as demonstrated by the following laboratory results obtained within 7 days before enrollment. Patients must not have received blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other supportive treatment affecting the relevant laboratory parameters within 14 days before the first dose of study treatment: Hemoglobin ≥90 g\u002FL; Platelet count ≥75 × 10⁹\u002FL; White blood cell count ≥3.0 × 10⁹\u002FL; Absolute neutrophil count ≥1.5 × 10⁹\u002FL; Total bilirubin ≤1.5 × the upper limit of normal (ULN); Serum creatinine ≤1.5 × ULN; Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN, or ≤5 × ULN in participants with liver metastases.\n9. Participants with active hepatitis B virus or hepatitis C virus infection must have received antiviral therapy for at least 14 days before the first dose of study treatment. Hepatitis B virus DNA must be ≤500 IU\u002FmL or ≤2,500 copies\u002FmL, and hepatitis C virus RNA must be below the lower limit of detection of the applicable assay. Such participants must be willing to continue effective antiviral treatment throughout the study.\n10. Voluntary participation in the study and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Histologically confirmed neuroendocrine tumor, mixed adenoneuroendocrine carcinoma, or other non-neuroendocrine carcinoma pathological types.\n2. History of another malignancy with a disease-free interval of less than 5 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or a gastrointestinal tumor confirmed to have been cured by endoscopic mucosal resection.\n3. Uncontrolled hypertension despite medical treatment, defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>90 mmHg.\n4. Urine protein ≥2+ on routine urinalysis or 24-hour urinary protein ≥1 g.\n5. Major surgery within 4 weeks before enrollment, excluding diagnostic biopsy, or an incompletely healed surgical wound.\n6. Severe gastrointestinal disorders that may affect drug absorption, including but not limited to peptic ulcer, ulcerative colitis, active gastrointestinal bleeding, gastrointestinal obstruction, or severe diarrhea.\n7. A history of severe bleeding within the previous 3 months, defined as a single bleeding episode of \\>30 mL; hemoptysis within the previous 1 month, defined as a single episode of \\>5 mL; or a thromboembolic event within the previous 12 months, including pulmonary embolism or cerebral infarction.\n8. Severe cardiovascular disease, including but not limited to acute myocardial infarction, unstable angina, heart failure, ventricular arrhythmia requiring medical treatment, left ventricular ejection fraction \\\u003C50%, or New York Heart Association cardiac functional class II or higher.\n9. Corrected QT interval (QTc) \\>480 ms on electrocardiography.\n10. Active autoimmune disease, a history of autoimmune disease with a risk of recurrence, or another condition requiring immunosuppressive treatment, such as prior organ transplantation. Participants with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, or skin disorders not requiring systemic treatment, such as vitiligo, psoriasis, or alopecia, may be enrolled.\n11. A history of interstitial lung disease or noninfectious pneumonitis that is symptomatic, or a previous pulmonary condition that may interfere with the evaluation or management of study treatment-related pulmonary toxicity.\n12. Active pulmonary tuberculosis within 1 year before the first dose of study treatment. Patients with a history of active pulmonary tuberculosis more than 1 year before the first dose must undergo careful evaluation, including sputum smear examination, T-SPOT.TB testing, erythrocyte sedimentation rate testing, and chest computed tomography. Such participants may be enrolled only if there is no evidence of active pulmonary tuberculosis.\n13. A history of chronic persistent diarrhea or the presence of complete intestinal obstruction.\n14. Requirement for systemic treatment with corticosteroids at a prednisone-equivalent dose of \\>10 mg\u002Fday or other immunosuppressive agents within 14 days before the first dose of study treatment. Inhaled or topical corticosteroids and adrenal replacement therapy at a prednisone-equivalent dose of ≤10 mg\u002Fday are permitted in the absence of active autoimmune disease. Short-term corticosteroid use for ≤7 days is permitted for prophylaxis, such as prevention of contrast-media allergy, or for the treatment of non-autoimmune conditions, such as delayed hypersensitivity caused by contact allergens.\n15. Prior treatment with any antibody or drug targeting a T-cell co-regulatory protein or immune checkpoint, including but not limited to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137, anti-TIM-3, or anti-LAG-3 therapies.\n16. Immunodeficiency disorder or human immunodeficiency virus infection.\n17. Severe medical or surgical comorbidities that impair organ function, or an acute infection associated with a body temperature \\>38°C, which, in the investigator's judgment, would make the patient unsuitable for the study.\n18. Leptomeningeal metastases or symptomatic brain metastases.\n19. Pregnant or breastfeeding women, or patients of reproductive potential, including male patients and women who have been postmenopausal for less than 1 year, who are unwilling to use effective contraception.\n20. A history of allergy or hypersensitivity to any component of the study treatments.\n21. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.","ALL","18 Years",{"count":19,"type":20},92,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The aim of this prospective, randomized, controlled clinical trial is to evaluate the efficacy and safety of iparomlimab and tuvonralimab injection (QL1706) plus lenvatinib and etoposide-based platinum chemotherapy, consisting of etoposide plus cisplatin or carboplatin, compared with etoposide-based platinum chemotherapy alone as first-line treatment for patients with extrapulmonary neuroendocrine carcinoma. Potential predictive biomarkers will also be explored through analyses of tumor tissue, peripheral blood, and relevant clinical and pathological data.",[26,27,28,29],"Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)","QL1706","Lenvatinib","Chemotherapy","NOT_YET_RECRUITING","2026-07-28",{"date":33,"type":34},"2026-07-31","ACTUAL",{"date":36,"type":20},"2026-08-01",{"date":38,"type":20},"2030-09-01",{"name":40,"class":41},"West China Hospital","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100489405","phase-1-a-study-of-peluntamig-pt217-in-patients-with-neuroendocrine-carcinomas-expressing-dll3-the-skybridge-study-100489405","NCT05652686","A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)","An Open-label, Multicenter, Dose Escalation, and Dose Expansion Phase 1\u002F2 Study With Peluntamig (PT217) Followed by a Key ChemotherapY and\u002For Checkpoint Inhibitor ComBination in Patients With NeuRoendocrIne Carcinomas That Are Known to be DLL3 expressinG CancErs (SKYBRIDGE)","Key Inclusion Criteria\n\n1. 18 years or older and able to sign informed consent and comply with the protocol.\n2. Measurable disease as defined by RECIST v1.1 criteria for solid tumors.\n3. NECs that have transformed from NSCLC are not eligible.\n\n   Part A: Patients with histologically or cytologically confirmed unresectable advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocrine carcinoma (EP-NEC). Patients with tumors that are of mixed histology are eligible only if neuroendocrine carcinoma\u002Fsmall cell cancer component is predominant and represents at least 50% of the overall tumor tissue. Patients with well differentiated grade 3 neuroendocrine tumors (Ki-67 ≥ 55%) may be considered if their tumors are DLL3 positive.\n\n   Patients may have progressed after standard of care treatments (at least one line of platinum-based chemotherapy with or without immune checkpoint inhibitor for SCLC patients) or other treatment options, or for whom treatment is not available or not tolerated.\n\n   Part B: Patients must meet the same eligibility criteria as patients in Part A, C or D.\n\n   Part C:\n   * Substudy C1: patients with LCNEC or EP-NEC eligible for first-line (1L) CE treatment. SCLC patients who have relapsed on a 1L treatment (including platinum-based therapy with or without ICI) but remain platinum sensitive (defined as patients who experienced disease progression at least 90 days after their last platinum based chemotherapy) and are eligible for CE treatment rechallenge.\n   * Substudy C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.\n   * Substudies C3 and C5: patients with SCLC eligible for 2L or 3L treatment with lurbinectedin (C3) or topotecan (C5) are eligible. Patients with SCLC who progressed on or were intolerant of DLL3-targeting therapies (including but not limited to tarlatamab) can be enrolled into substudies C3 or C5 for 3L treatment.\n   * Substudy C4: patients with SCLC, LCNEC or EP-NEC eligible for 2L irinotecan, or patients with SCLC eligible for 3L irinotecan. Patients with SCLC who progressed on or were intolerant of DLL3-targeting therapies (including but not limited to tarlatamab) can be enrolled into substudy C4 for 3L treatment.\n\n   Part D:\n   * Substudy D1: will include 2L patients with SCLC, LCNEC, pr EP-NEC (excluding GEP-NEC) that have progressed\u002Frelapsed from their first-line treatment that may have included an ICI.\n   * Substudy D2: will include 1L ES-SCLC patients that have completed their induction therapy with carboplatin and etoposide plus atezolizumab and are eligible to continue with atezolizumab. These patients must have either stable disease or partial response prior to enrollment.\n   * Substudy D3: will include 1L ES-SCLC patients that are treatment naïve or have received C1D1\u002F2\u002F3 and are eligible for treatment with CE plus atezolizumab.\n4. Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably a newly acquired biopsy, or if not possible, archival tissue) to be assessed for DLL3 expression and other biomarkers.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function confirmed at screening and within 72 hours of initiating C1D1 of Peluntamig (PT217) treatment.\n\nKey Exclusion Criteria\n\n1. Women who are pregnant or lactating.\n2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.\n3. Autoimmune disease requiring systemic treatment within the past twelve months.\n\nAdditional inclusion and exclusions criteria will apply.",{"count":50,"type":20},203,[52,23],"PHASE1","This is a first-in-human, Phase 1\u002F2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig (PT217) as a monotherapy and in combination with chemotherapy.",[55,56,57,58,59,26],"Small Cell Lung Cancer (SCLC)","Large Cell Neuroendocrine Cancer (LCNEC)","Neuroendocrine Prostate Cancer (NEPC)","Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)","Neuroendocrine Carcinomas (NEC)",[61,62,63,64,65,66,67,68,69,70,71,72,73,74,75],"DLL3","DLL3 expressing tumors","Lung cancer","SCLC","LCNEC","NEPC","GEP-NEC","Small Cell Lung Cancer","Large cell neuroendocrine cancer","Neuroendocrine prostate cancer","Gastroenteropancreatic neuroendocrine carcinoma","Neuroendocrine carcinoma","Extrapulmonary neuroendocrine carcinoma","EP-NEC","CD47","RECRUITING","2026-07-13",{"date":79,"type":34},"2026-07-15",{"date":81,"type":34},"2023-09-05",{"date":83,"type":20},"2028-08",{"name":85,"class":86},"Phanes Therapeutics","INDUSTRY",15,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":5},"100630534","phase-1-a-first-in-human-fih-phase-1-study-of-ml261-an-autologous-potency-enhanced-anti-dll3-car-t-cell-therapy-in-participants-with-rr-sclc-or-select-necs-spectral-1-100630534","NCT07488923","A First-in-human (FIH), Phase 1 Study of ML261, an Autologous Potency Enhanced Anti-DLL3 CAR T Cell Therapy, in Participants With R\u002FR SCLC or Select NECs (SPECTRAL-1)","A Phase 1 First-In-Human Study to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of ML261, an Autologous Anti-DLL3 CAR + CARD11-PIK3R3 Fusion T Cell Therapy, in Participants With Relapsed\u002FRefractory Small Cell Lung Cancer or Select Neuroendocrine Carcinomas","Inclusion Criteria\n\n* ≥18 years of age at the time of signing the ICF\n* Have been previously treated with at least one line of systemic standard of care (SOC) anti-cancer therapy for their respective cancer indication. Participants with locally advanced disease who are eligible for curative resection will be excluded.\n* Have documented radiological disease progression\u002Frelapse during or after their most recent line of anti-cancer therapy with measurable disease on imaging, as assessed by RECIST v1.1\n* Have histologically and\u002For cytologically confirmed diagnosis of select advanced or metastatic R\u002FR solid tumor malignancy in one of the following: R\u002FR SCLC, R\u002FR GEP-NEC, R\u002FR high-grade NEPC, R\u002FR epNEC with biopsy-documented DLL3 expression on archival tissue or fresh biopsy by local or central assessment. CNS NEC is excluded. Participants with mixed histologies for any of these indications qualify if the small cell\u002Fneuroendocrine tumor cell percentage is \\> 50%, except for high-grade NEPC where neuroendocrine component must be \\> 20%.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0 or 1\n* Life expectancy ≥12 weeks\n* Have adequate hematologic and end-organ function\n\nExclusion Criteria:\n\n* Previous systemic anti-cancer therapies within the timeframes, as specified in the protocol.\n* Prior exposure\u002Ftreatment with DLL3-targeted CAR T therapy or any other genetically engineered adoptive T cell therapy.\n* Prior allogeneic organ transplant (including allogeneic bone marrow transplant).\n* Major surgical procedure within 4 weeks of the first dose of any study drug administration or anticipated to be in need of a major surgical procedure during the course of study.\n* Participants with toxicities (as a result of prior anti-cancer therapy) which have not recovered to baseline or CTCAE v5.0 \\\u003CGrade 2, except for adverse events (AEs) not considered a likely safety risk: (e.g., alopecia, neuropathy, non-clinically relevant laboratory abnormalities).\n* Symptomatic ascites or effusions (pleural or pericardial) requiring intermittent drainage.\n* History of any other malignancy known to be active, with the exception of completely removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, ductal carcinoma in situ, early-stage prostate cancer that has been adequately treated, and other cancers from which the participant has been disease free for 3 years or longer or does not require treatment and in the opinion of investigator after discussion with the medical monitor are not likely to impact the patient's life expectancy.\n* One or more of the following cardiac criteria: Unstable angina, Myocardial infarction within 6 months prior to Screening, New York Heart Association Class III to IV heart failure, clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block or third-degree heart block)\n* Acute venous thromboembolism (VTE). VTEs without hemodynamic compromise, treated with stable doses of anticoagulants are allowed.\n* Presence of clinically significant CNS pathology:\n\n  * seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, or cerebellar disease. History of these disorders requires discussion with the medical monitor.\n  * Presence of clinically active psychosis.\n  * Known brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the first dose of any study drug administration.\n* Active systemic autoimmune disease or any other condition that requires, or is anticipated to require, systemic treatment with steroids or other systemic immunosuppressive agents, or participants who have received such agents within 4 weeks of leukapheresis and ML261 administration (further details provided in protocol body).\n* Evidence of interstitial lung disease (such as idiopathic pulmonary fibrosis) or active pneumonitis of any etiology requiring treatment.\n* Any active infection (defined as symptoms, signs, or radiographic) of bacterial, viral, or fungal or unknown etiology requiring systemic therapy within 14 days of leukapheresis. Participants with clinical and\u002For laboratory evidence of persistent infection will be excluded.\n* Uncontrolled medical, psychological\u002Fpsychiatric, or social condition that would interfere with the participant's participation or compromise the objectives of the study in the opinion of the Investigator and\u002For the Sponsor.",{"count":96,"type":20},110,[52],"This is a first-in-human (FIH), open-label, Phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of ML261, an autologous potency enhanced anti-DLL3 CAR T cell therapy, in participants with R\u002FR SCLC or select NECs",[100,26,101,57],"Small Cell Lung Cancer (SCLC )","Gastroenteropancreatic NEC (GEP NEC)",[72,61,103],"CAR T","2026-06-22",{"date":106,"type":34},"2026-06-25",{"date":108,"type":20},"2026-06",{"date":110,"type":20},"2030-08",{"name":112,"class":86},"Moonlight Bio, Inc",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":129,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":5},"100614352","phase-1-study-of-212pbpb-dotam-mam279-212pbpb-mp0712-in-patients-with-small-cell-lung-cancer-and-other-dll3-expressing-solid-tumors-100614352","NCT07278479","Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors","A Phase 1\u002F2a Study to Assess Safety, Tolerability, and Efficacy of [212Pb]Pb-DOTAM-MAM279 in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Histologically or cytologically confirmed: I. advanced extensive or limited SCLC or LC NECs of the lung\n\n  * SCLC (extensive stage, or limited stage) patients with progression or recurrence following at least two prior line of systemic platinum based therapy and immunotherapy or are not suitable or tolerating the standard of care treatment as second line of systemic therapy, or\n  * LC NEC of the lung patients with progression or recurrence following at least one prior line of systemic therapy, or II. epNECs with progression or recurrence following at least one prior line of systemic therapy:\n  * Gastroenteropancreatic NECs (GEPNEC), or\n  * Cervical NECs, or\n  * Bladder NECs, or\n  * other epNECs with previously confirmed DLL3 expression by IHC.\n  * Patients with prior DLL3-targeted therapy are allowed.\n* For epNECs in Part 1 and Part 2 and SCLC or LC NECs of the lung in Part 2: DLL3-positivity by \\[203Pb\\]Pb-DOTAM-MAM279 SPECT\u002FCT\n* Radiographically documented disease progression or recurrence during or after the last line of systemic treatment therapy\n* At least one measurable disease per RECIST v1.1.\n* Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening\n* Adequate blood counts: Hemoglobin ≥9 g\u002FdL; Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL; Platelets ≥100 × 10\\^9\u002FL; White blood cells (WBC) ≥2.5 x 10\\^9\u002FL;\n* Adequate hepatic function\n* Adequate renal function: Calculated glomerular filtration rate (GFR) \\>60mL\u002Fmin (using Cockroft-Gault formula).\n* Patients with known central nervous system (CNS) metastasis will be eligible if they are clinically stable.\n\nKey Exclusion Criteria:\n\n* Uncontrolled intercurrent illness\n* Patients who have not had resolution of all clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for grade ≤2 alopecia, or stable grade 2 sensory neuropathy, according to the last CTCAE version).\n* Active clinically significant cardiac disease\n* Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* History of other malignancy within the past 2 years with exceptions.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":121,"type":20},138,[52,23],"The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[212Pb\\]Pb-MP0712, in patients aged ≥18 years with Small Cell Lung Cancer and other locally advanced or metastatic DLL3 positive tumors.",[125,126,26,55,101,127,128],"Large Cell Neuroendocrine Carcinoma","Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC)","NEC of the Bladder","Other DLL3 Expressing epNEC",[130,131,132,133,61,134,64,135,136,137,74,138,139,140,141],"DARPin","Alpha Emitter","Pb203","Pb212","Radioligand therapy (RLT)","Neuroendocrine cancer","[203Pb]Pb-DOTAM-MAM279","[212Pb]Pb-DOTAM-MAM279","Lead 212","Lead 203","203Pb","212Pb","2026-05-21",{"date":144,"type":34},"2026-05-22",{"date":146,"type":34},"2026-05-18",{"date":148,"type":20},"2032-09",{"name":150,"class":86},"Molecular Partners AG",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100632816","phase-2-efficacy-and-safety-of-chidamidesintilimabbev-as-second-line-therapy-in-advanced-extrapulmonary-neuroendocrine-carcinoma-100632816","NCT07518602","Efficacy and Safety of Chidamide+Sintilimab+Bev as Second-Line Therapy in Advanced Extrapulmonary Neuroendocrine Carcinoma","Evaluation of Efficacy and Safety of Chidamide+Sintilimab+Bevacizumab in Subjects With Advanced Extrapulmonary Neuroendocrine Carcinoma Who Have Failed First-Line Standard Therapy: A Single-Arm, Phase II, Multicenter Study","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced, unresectable, or metastatic extrapulmonary neuroendocrine carcinoma (NEC).\n2. Failure of first-line standard systemic therapy, with documented disease progression during or after treatment by imaging or clinical evidence (e.g., cytology of new ascites or pleural effusion). Patients who discontinued first-line therapy due to intolerable toxicity are eligible.\n3. At least one measurable lesion per RECIST version 1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Able to provide written informed consent and comply with study visits and procedures.\n6. Age ≥ 18 years and ≤ 75 years.\n7. Life expectancy ≥ 12 weeks.\n8. Women of childbearing potential and men with female partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the last dose of study treatment.\n9. Adequate organ and bone marrow function within 7 days before enrollment, without support treatments (blood products, growth factors, albumin) within 14 days before testing: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 100 × 10⁹\u002FL; hemoglobin (HGB) ≥ 9.0 g\u002FdL; serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); ALT\u002FAST ≤ 3.0 × ULN (no liver metastasis) or ≤ 5.0 × ULN (with liver metastasis); serum albumin ≥ 25 g\u002FL; serum creatinine (Cr) ≤ 1.5 × ULN; urine protein \\\u003C 2+ or 24-hour urine protein \\\u003C 1 g if urine protein ≥ 2+; INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN.\n\nExclusion Criteria:\n\n1. Prior exposure to any anti-angiogenic therapy or histone deacetylase (HDAC) inhibitor.\n2. Received any investigational drug within 4 weeks before the first dose of study treatment.\n3. Simultaneously participating in another interventional clinical study (observational or follow-up studies are allowed).\n4. Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, embolization, etc.) within 3 weeks before first dose.\n5. Received radiotherapy within 4 weeks before first dose.\n6. Residual radiation-related toxicity (e.g., pneumonitis, hepatitis, enteritis) from prior radiotherapy \\> 4 weeks before first dose, including symptomatic cases or those requiring corticosteroids.\n7. Received systemic immunosuppressive drugs within 4 weeks before first dose, except topical\u002Finhaled corticosteroids or physiological systemic corticosteroids (≤ 10 mg\u002Fday prednisone equivalent).\n8. Received or plans to receive live attenuated vaccines within 4 weeks before first dose or during the study.\n9. Underwent major surgery within 4 weeks before first dose, or has unhealed wounds, ulcers, or fractures.\n10. Resolved toxicity from prior anti-tumor therapy not recovered to NCI CTCAE version 5.0 grade ≤ 1 (except alopecia or non-clinically significant laboratory abnormalities).\n11. Known symptomatic central nervous system (CNS) metastases or carcinomatous meningitis. Patients with treated and stable CNS metastases for ≥ 4 weeks and neurological symptoms recovered to grade ≤ 1 are allowed.\n12. Active autoimmune disease requiring systemic therapy within 2 years before first dose; or primary immunodeficiency. Replacement therapy (e.g., thyroid hormone, insulin) is permitted.\n13. Active tuberculosis, or anti-tuberculosis treatment within 1 year before first dose.\n14. Interstitial lung disease requiring corticosteroid treatment.\n15. Active hepatitis B (HBsAg positive and HBV DNA ≥ 200 IU\u002FmL) or active hepatitis C (HCV antibody positive and HCV RNA positive).\n16. Known HIV infection or syphilis.\n17. Severe uncontrolled active infection, including hospitalization for infection within 4 weeks before first dose.\n18. Significant malnutrition requiring intravenous nutrition, unless corrected for \\> 4 weeks before first dose.\n19. Symptomatic congestive heart failure (NYHA class II-IV), or symptomatic\u002Funcontrolled arrhythmia.\n20. Uncontrolled arterial hypertension despite optimal treatment (systolic BP ≥ 150 mmHg or diastolic BP ≥ 100 mmHg).\n21. Any arterial thromboembolic event (myocardial infarction, pulmonary embolism, unstable angina) within 6 months before enrollment.\n22. History of deep vein thrombosis or other severe thromboembolism within 3 months before enrollment (catheter-related or superficial vein thrombosis excluded).\n23. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B or C cirrhosis.\n24. History of gastrointestinal perforation\u002Ffistula, peptic ulcer, bowel obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis, intra-abdominal abscess, or chronic diarrhea within 6 months before enrollment; or intestinal stent placement.\n25. Uncontrolled metabolic disorders or other severe medical conditions that may increase study risk or confound result interpretation.\n26. Hereditary bleeding tendency or coagulation disorder.\n27. Any life-threatening bleeding event within 3 months before enrollment (requiring transfusion, surgery, or continuous treatment).\n28. High bleeding risk per investigator assessment: severe esophageal\u002Fgastric varices, intermittent bleeding (e.g., hematochezia, hemoptysis).\n29. Cerebrovascular accident (including transient ischemic attack) within 6 months before enrollment.\n30. Use of aspirin (\\> 325 mg\u002Fday) or other platelet inhibitors for 10 consecutive days within 10 days before first dose.\n31. Use of oral or parenteral anticoagulants or thrombolytics for 10 consecutive days within 10 days before first dose (prophylactic anticoagulation allowed).\n32. Symptomatic or drainable pleural effusion, ascites, or pericardial effusion (only small asymptomatic effusions by imaging are allowed).\n33. History of other primary malignancy, except: Malignancy in complete remission for ≥ 2 years without treatment during study；adequately treated non-melanoma skin cancer or carcinoma in situ with no evidence of recurrence.\n34. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n35. Known hypersensitivity to any monoclonal antibody component or study drug excipients.\n36. Pregnant or breastfeeding female patients.\n37. History of alcoholism or drug abuse.\n38. Any other acute or chronic disease, psychiatric disorder, or laboratory abnormality that, in the investigator's opinion, increases study risk or interferes with result interpretation.","75 Years",{"count":160,"type":20},34,[23],"This is a single-arm, multicenter phase Ⅱ study to evaluate the therapeutic efficacy and safety of chidamide + sintilimab + bevacizumab in subjects with advanced extrapulmonary neuroendocrine carcinoma who have failed first-line standard therapy. The primary purpose is to assess the objective response rate (ORR) of chidamide + sintilimab + bevacizumab in the above-mentioned subjects, with a planned enrollment of 34 subjects with advanced extrapulmonary neuroendocrine carcinoma who have failed first-line standard therapy.",[26],[165,166,167,168],"extrapulmonary neuroendocrine carcinoma","chidamide","sintilimab","bevacizumab","2026-04-02",{"date":171,"type":34},"2026-04-08",{"date":173,"type":20},"2026-03-27",{"date":175,"type":20},"2028-09-27",{"name":177,"class":41},"Sun Yat-sen University",1]