[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-carcinomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-carcinomas":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100519282","phase-1-a-first-in-human-phase-i-trial-with-antibody-drug-conjugate-adct-701-in-neuroendocrine-tumors-carcinomas-and-malignant-peripheral-nerve-sheath-tumors-100519282",false,"NCT06041516","A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC) or malignant peripheral nerve sheath tumors (MPNST).\n* Locally advanced, unresectable or metastatic disease (as confirmed by a radiological evaluation)\n* Participants must have measurable disease per RECIST 1.1.\n* Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s). Note: Patients with MPNST who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic\n\nchemotherapy is felt to be in the best interest for the patient by the local investigator and treating investigator will also be eligible.\n\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 2.\n* Adequate hematologic function as follows:\n\n  * Leukocytes \\>= 3,000\u002Fmicroliter\n  * Absolute neutrophil count (ANC) \\>= 1,200\u002Fmicroliter (off-growth factors for 72 hours prior to treatment initiation)\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL with no blood transfusion within 2 weeks prior to treatment initiation\n  * Platelets \\>= 100,000\u002Fmicroliter with no platelet transfusion within 1 week.\n* Adequate renal and hepatic function as follows:\n\n  * Creatinine clearance (CrCl) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (calculated CrCl (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or calculated eGFR provided by a laboratory))\n  * Total bilirubin \\\u003C= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin \\\u003C= 3.0 x ULN\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 2.5 x ULN, (unless liver metastases are present, then values must be \\\u003C= 5 x ULN).\n* Participants serologically positive for hepatitis C virus (HCV) must have an undetectable HCV viral load.\n* Participants serologically positive for Hepatitis B (HBV) core antibody or surface antigen must be on adequate anti-viral therapy and Hepatitis B Viral deoxyribonucleic acid (DNA) load must be \\\u003C2000 IU\u002FmL.\n* Participants serologically positive for human immunodeficiency virus (HIV) must be on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \\>= 200 cells per cubic millimeter.\n* Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms.\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 9.5 months after the last dose of the ADCT-701 (restriction period).\n\nIndividuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 6.5 months after the last dose of the ADCT-701.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6.5 months after study treatment discontinuation.\n* Participants or legally authorized representative (LAR) must be able to understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and\u002For radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation.\n* Participants taking any herbal supplements within 14 days prior to treatment initiation.\n* Participants who have wound dehiscence from prior surgeries.\n* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requires drainage or is associated with shortness of breath) at screening.\n* Active infection requiring systemic antibiotic therapy at screening.\n* Active bleeding diathesis or therapeutic anticoagulation with an oral vitamin K antagonist with target international normalized ratio (INR) \\> 2 at screening.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug.\n* An active autoimmune disease. Note: Participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\\\u003C= the equivalent of prednisone 10 mg\u002Fday), or other mild autoimmune disorders (Type 1 diabetes, eczema, vitiligo, alopecia, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, adrenal insufficiency due to Addison's disease, hypothyroidisms due to Hashimoto's thyroiditis, hyperthyroidisms due to Graves disease, Sjogren s syndrome, celiac disease, pernicious anemia) not requiring immunosuppressive treatment are eligible.\n* Congenital long QT syndrome, or a corrected QTcF interval of \\>=480 ms, at screening (unless secondary to the pacemaker or bundle branch block).\n* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that does not require current anticancer treatment per standard of care.\n* Live vaccine administration within 30 days prior to treatment initiation.\n* Pregnant individuals (confirmed by Beta-Human Chorionic Gonadotropin \\[Beta-HCG\\] serum or urine pregnancy test) performed at screening.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Background:\n\nNeuroendocrine neoplasms (NENs) are rare cancers in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas of the body. Many of these cancers have a high risk of relapse and a low chance of survival. Better treatments are needed.\n\nObjective:\n\nTo test a new drug, ADCT-701, in people with NENs.\n\nEligibility:\n\nAdults aged 18 and older with NENs.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of heart functioning. Their ability to perform normal daily activities will be tested. A biopsy may be needed: A sample of tissue will be removed from the tumor.\n\nADCT-701 is given through a tube attached to a needle inserted into a vein in the arm. Participants will receive the drug treatment on the first day of 21-day treatment cycles. They will visit the clinic a total of 10 times during the first two cycles. After that, they will visit the clinic 2 times during each cycle. Imaging scans, blood draws, heart function tests, and other tests will be repeated during study visits. Each visit will last up to 8 hours.\n\nParticipants may continue receiving treatment with the study drug for up to 2 years.\n\nAfter treatment ends, participants will have follow-up clinic visits 4 times in 4 months. They will have a physical exam, with heart and blood tests, at each visit. After that, they will have follow-up clinic visits every 9 weeks; these visits will include imaging scans.\n\nFollow-up visits will continue for up to 5 years after treatment began....",[26,27,28,29,30],"Neuroendocrine Carcinomas","Neuroendocrine Tumors","Carcinoma, Neuroendocrine","Carcinoma, Adrenocortical","Carcinoma, Adrenal Cortical",[32,33,34,35,36,37,38],"Pheochromocytoma","Neuroblastoma","Neuroendocrine Tumor","Neuroendocrine carcinoma","Neuroendocrine neoplasms","Paraganglioma","Adrenocortical Carcinoma","RECRUITING","2026-06-12",{"date":42,"type":43},"2026-06-15","ACTUAL",{"date":45,"type":43},"2024-06-17",{"date":47,"type":20},"2029-10-30",{"name":49,"class":50},"National Cancer Institute (NCI)","NIH",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100606363","phase-1-a-study-of-ide849-in-patients-with-dll3-expressing-tumors-including-small-cell-lung-cancer-100606363","NCT07174583","A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients With DLL3-Expressing Tumors Including Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF.\n2. Subjects with histologically or cytologically confirmed extensive-stage SCLC neuroendocrine carcinoma (NEC), and other DLL3+ tumors, are eligible per protocol. Subjects must have radiologically progressed or recurred after previous standard treatment, For SCLC, this includes platinum-based therapy and programmed death-1\u002Fprogrammed death-ligand 1 inhibitors (except for subjects who refuse or are judged by the Investigator to be unsuitable for immunotherapy). No more than 2 lines of previous systemic chemotherapy in any setting and no more than 3 total lines of systemic therapy in the recurrent or metastatic setting will be allowed.\n3. Subjects will be required to provide blood\u002Ftumor tissue samples for biomarker testing.\n4. Have at least 1 measurable lesion according to RECIST version 1.1.\n5. Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n6. Have life expectancy \\> 3 months.\n7. Have adequate bone marrow and organ function.\n8. Women of childbearing potential must agree to take highly effective contraceptive measures from signing of consent through 8 months after the last dose of IDE849; men with partners of child-bearing potential must use effective contraception through 5 months after the last dose.\n\nExclusion Criteria:\n\n1. Have mixed SCLC and nonsmall cell lung cancer histology (SCLC with components of large cell neuroendocrine carcinoma are eligible).\n2. Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.\n3. Have had other malignancies within 2 years prior to the first dose, except adequately treated carcinoma in situ (cervical, breast, or other), basal cell or squamous cell skin cancer, localized prostate cancer after curative therapy with no recurrence, or papillary thyroid cancer after curative resection; other prior or concurrent malignancies may be eligible with Medical Monitor review and approval.\n4. Have uncontrolled tumor-associated pain.\n5. Have severe cardiovascular and cerebrovascular disease\n6. Have history of clinically significant bleeding within 3 months before the first study dose.\n7. Have history of interstitial pneumonitis during previous treatment; current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose, including, but not limited to, idiopathic pulmonary fibrosis and organizing pneumonia\u002Fobliterative bronchiolitis.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test.\n9. Subjects with known or suspected viral hepatitis.\n10. Have a history of active tuberculosis within 1 year before enrollment.\n11. For participants enrolling to receive the combination with durvalumab, must not have had any prior Grade 2 or higher myocarditis or any other Grade 3 or higher immune-related AE. If the participant has had a prior immune-related AE, must have recovered to \\\u003C Grade 1\n12. For participants enrolling to receive the combination with IDE161, must not have had prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect eg, malabsorption disorder such as Crohn's disease or ulcerative colitis, that would interfere with absorption of IDE161\n13. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted anti-tumor treatments within 2 weeks before the first dose of IMP; for small molecule treatments within 2 weeks before the first dose of the IMP or within 5 half lives of the drug (whichever is longer); other investigational products within 4 weeks or within 5 half-lives of the drug (whichever is longer) unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study. Participants who received an immunotherapy agent (eg, PD-1\u002FPD-L1 inhibitor) immediately prior to study enrollment must have documented radiologic disease progression as per the Investigator prior to first dose of IMP\n14. Administration of any of the following:\n\n    * Strong inhibitors or inducers of CYP3A4\n    * Strong inhibitors of CYP2D6\n    * Strong inhibitors of P-gp or BCRP\n    * Use of drugs with a known risk of QT prolongation\n15. For participants enrolling to receive the combination with IDE161:\n\n    * Use of drugs of narrow therapeutic index that are sensitive substrates of MATE2-K, BCRP, and P-gp\n    * Use of known moderate and strong CYP3A4\u002F5 inducers and inhibitors is not permitted\n    * Administration of PPIs\n    * Use of an H2 blocking agent\n    * Use of a local antacid\n    * Use of drugs with a known risk of QT prolongation\n16. Have prior treatment with DLL3 ADC or prior treatment with a topoisomerase I inhibitor including an ADC with a topoisomerase I inhibitor payload.\n17. For participants enrolling to receive the combination with durvalumab, have history of prior intolerance to PD-1\u002FPD-L1 inhibitors\n18. Have received \\> 30 Gy of chest radiotherapy within 12 weeks prior to the first dose of the IMP, \\> 30 Gy of non-chest radiotherapy within 4 weeks prior to the first dose (subjects who have completed radiotherapy for brain metastases within 14 days prior to the first dose can be enrolled and palliative radiotherapy for other sites of ≤ 30 Gy is allowed if completed more than 14 days prior to the first dose).\n19. Have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose.\n20. Female subjects who are pregnant, lactating, or planning to become pregnant during the study period to 8 months after the last dose of the IMP.",{"count":60,"type":20},208,[23,62],"PHASE2","This is Phase 1\u002F2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.",[65,26,66],"Small-cell Lung Cancer","Solid Tumor Show to Express DLL3",[68,69,70,71,72,26,73,74,75],"IDE849","Small Cell Lung Cancer","SCLC","anti-DLL3 immunoglobulin G1 monoclonal antibody","DLL3","NEC","durvalumab","IDE161","2026-01-21",{"date":78,"type":43},"2026-01-23",{"date":80,"type":43},"2025-10-14",{"date":82,"type":20},"2029-05",{"name":84,"class":85},"IDEAYA Biosciences","INDUSTRY",39,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":96,"phases":4,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100607779","neuroendocrine-carcinomas-patient-journey-and-treatment-outcomes-in-latin-america-100607779","NCT07192991","Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America","NECTARINE","Inclusion Criteria:\n\n* ≥18 years old\n* Diagnosed between August 2014 and August 2024 with one of the following:\n* Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)\n* Large-cell neuroendocrine carcinoma (LCNEC) or mixed\n* Small Cell Lung Cancer (SCLC) or mixed\n* Adequate and accessible medical records for data collection\n* Tumor block collected from 2014 onwards\n\nExclusion Criteria:\n\n* Patients with active, concurrent malignancies at the time of NEC diagnosis, except for non-invasive cancers like basal cell carcinoma or squamous cell carcinoma of the skin, or in situ cervical cancer.\n* Patients or their legal representatives unwilling or unable to provide informed consent (if needed per ethics committee).",{"count":95,"type":20},200,"OBSERVATIONAL","This observational, retrospective study aims to understand the treatment patterns and outcomes of patients with pulmonary and extra-pulmonary neuroendocrine carcinomas (NEC) in Latin America (Brazil, Mexico, Argentina, and Peru). The research will collect data from medical records to analyze factors like patient demographics, diagnosis methods, tumor characteristics, treatment approaches, and disease progression. The study is non-interventional, meaning patient care will follow standard clinical practice, with data gathered via an electronic system.",[26,99],"Lung Neuroendocrine Carcinoma","NOT_YET_RECRUITING","2025-09-24",{"date":103,"type":43},"2025-09-25",{"date":105,"type":20},"2025-11-03",{"date":107,"type":20},"2026-09-30",{"name":109,"class":110},"Latin American Cooperative Oncology Group","OTHER"]