[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-carcinoma-of-prostate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-carcinoma-of-prostate":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":45},"100588444","phase-1-a-study-of-177lu-dtpa-sc1656-in-people-with-neuroendocrine-carcinomas-of-the-lung-and-prostate-100588444",false,"NCT06941480","A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine Carcinomas of the Lung and Prostate","Characterizing the Theranostic Potential of DLL3-targeting Agents in High-grade Neuroendocrine Carcinomas of the Lung and Prostate","Inclusion Criteria:\n\n* Subjects with histologically proven progressive metastatic high-grade neuroendocrine carcinomas of the lung (small-cell lung cancer) and prostate (neuroendocrine prostate cancer) that has relapsed following at least 1 line of standard chemotherapy i. Prostate cancer patients will be defined by either of the following criteria: ii. The presence of chromogranin staining on tissue iii. At least two of the pathogenic mutations of PTEN, RB1, or p53 iv. Disease exclusively involving the viscera v. Disease in which the PSA is \\\u003C10 but the number of bone lesions is \\>20 vi. Histologic evidence of small cell carcinoma or other stains consistent with neuroendocrine disease (on the primary disease or metastases) vii. DLL3 positivity on previously available tissue specimens\n* Ability to understand and willingness to sign a written informed consent document\n* Aged 18 years or older at the time of signing consent\n* Progression of disease defined by one of the following occurring within 3 months of study entry:\n\n  i. At least a 20% increase in radiologically or clinically measurable disease; ii. Appearance of any new lesion; iii. For prostate cancer patients progression criteria will be per PCWG3: iv. Either v. A rising PSA over a sequence of at least 1-week intervals OR i. An increase in soft tissue disease to qualify for disease progression by RECIST 1.1 OR ii. Two new bone lesions by bone scintigraphy\n\nPatients with metastatic disease by virtue of disease exclusively evident by PSMA PET will not be eligible. All patients must have metastatic disease by evidence of standard scintigraphic or anatomic imaging in accord with PCWG3\n\n* At least one tumor lesion on CT or MR ≥ 2 cm\n* ECOG performance status 0 to 2\n* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.\n* Previous chemotherapy, immunotherapy, and\u002For investigational agents are allowed if completed ≥4 weeks prior to study entry. For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.\n* Preserved hematological function:\n\n  i. Hb ≥9.0 g\u002FdL; ii. WBC ≥3000\u002Fmm3; iii. ANC≥1500\u002Fmm3; iv. Platelets ≥75.000\u002Fmm3\n* Preserved renal function:\n\n  i. Serum creatinine ≤1.7 mg\u002FdL ii. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73m2\n* Preserved hepatic function:\n\n  i. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN) or ≤ 5 x ULN if liver metastases are present ii. bilirubin ≤ 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis)\n* Willingness to undergo baseline and follow up biopsy to obtain tissue for DLL3 IHC and genomic analyses\n* In order to proceed with the treatment with 177Lu-DTPA-SC16.56, patients must exhibit overexpression of DLL3, as SUVmax greater than in normal liver, in ≥80% of tumor lesions among the growing progressing lesions that are ≥2cm.\n\nExclusion Criteria:\n\n* History of anaphylactic reaction to humanized or human antibodies\n* History of severe allergic reaction to X-ray contrast medium despite premedication\n* Prior treatment with Rova-T (rovalpituzumab)\n* Women who are pregnant or unwilling to discontinue breastfeeding\n* Spinal cord compression or symptomatic\u002Funcontrolled epidural disease, unless treated and stable for at least 1 week prior to enrolment.\n* Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 4 months for males and 7 months for females after receiving the therapeutic study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation\u002Focclusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women)\n* Life expectancy \\\u003C 6 months as assessed by the treating physician.\n* Unresolved toxicities from prior antitumor therapy, defined per Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, to to grade 1 or grade 0 or to levels dictated in the inclusion criteria.\n* Major surgery within 28 days of enrolment with the exception of biopsy and insertion of central venous catheter.\n* Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Known parenchymal brain metastases and\u002For carcinomatous meningitis, unless these metastases have been treated and stabilized.\n* Unmanageable urinary incontinence rendering the administration of 177Lu-DTPA-SC16.56 unsafe (e.g., urinary catheterization not feasible).\n* Other ongoing invasive malignances (i.e., not carcinomas in situ, non-mm invasive urothelial cancer, or other non-invasive tumors), and prior cancers that have been treated that have a \\>30% likelihood of relapse within the next two years.\n* Subjects likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the subject's and investigator's knowledge.\n* Prostate cancer patients with mixed histologies (i.e., neuroendocrine and adenocarcinomas) are eligible provided that they meet all of the above eligibility criteria.\n* Patients for whom their clinicians believe would benefit by continuing their treatments for their disease to control any adenocarcinoma (such as ADT or other AR axis directed therapy) can and should remain on those treatments while on this protocol, if their clinician believes that it would be clinically beneficial to do so.\n* Concurrent chemotherapy, other radiopharmaceuticals of any type, and immunotherapy are excluded\n* Complementary approaches known to modulate PSA should not be taken while on this trial","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to find out whether 177Lu-DTPA-SC16.56 is a safe treatment for people with small-cell lung cancer or neuroendocrine prostate cancer",[26,27,28,29],"Neuroendocrine Tumor of the Lung","Neuroendocrine Carcinoma of Lung","Neuroendocrine Carcinoma","Neuroendocrine Carcinoma of Prostate",[26,27,28,29,31,32,33],"177Lu-DTPA-SC16.56","Memorial Sloan Kettering Cancer Center","24-330","NOT_YET_RECRUITING","2026-04-13",{"date":37,"type":38},"2026-04-14","ACTUAL",{"date":40,"type":20},"2026-06",{"date":42,"type":20},"2030-05",{"name":32,"class":44},"OTHER",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100584778","phase-2-efficacy-and-safety-evaluation-of-tarlatamab-in-advanced-extrapulmonary-neuroendocrine-carcinoma-patients-100584778","NCT06893783","Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients","A Phase II Trial of Tarlatamab, a DLL3-targeted Bispecific T-cell Engager, in Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (DeLLight)","DeLLight","Inclusion Criteria:\n\n\\- Subject has provided informed consent prior to initiation of any study specific activities\u002Fprocedures.\n\n* Age ≥19 years at the time of signing the informed consent.\n* Histologically confirmed relapsed\u002Frefractory extra-pulmonary neuroendocrine carcinoma. Neuroendocrine carcinoma includes small cell carcinoma, large cell carcinoma, and mixed histology of neuroendocrine and other histology (e.g., adenoneuroendocrine carcinoma, urothelial carcinoma with neuroendocrine component). In patients with prostate cancer, treatment-emergent neuroendocrine carcinoma (initially adenocarcinoma, but transdifferentiate into neuroendocrine carcinoma after androgen deprivation therapy) will be permitted.\n* Cohort 1 (gastrointestinal and pancreaticobiliary cohort): cancers originated from stomach, esophagus, small intestine, colorectal, pancreas, or bile ducts.\n* Cohort 2 (genitourinary cohort): cancers originated from prostate, bladder, ureter, urethra, or kidney.\n* Subject has progressed or recurred following 1 platinum-based regimen:\n* documented first disease progression must be during or following first-line platinum-based systemic chemotherapy. For patients with prostate cancer, especially in cases with treatment-emergent neuroendocrine carcinoma, platinum-based chemotherapy will not need to be the first line therapy.\n\n  * patients who received treatment for localized disease who recur are eligible\n  * patients who received adjuvant Platinum-Etoposide (EP) after resection of their primary tumor who recur are eligible\n* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.\n\n  • Screening scans performed as SOC(Standard of Care) and prior to informed consent, may be used to confirm subject eligibility if completed within the 21-day screening period, provided that informed consent for the use of these scans is obtained prior to any transfer of data.\n  * In patients with prostate cancer, patients without RECIST-defined measurable lesion can be included, if disease can be evaluated with Prostate Cancer Working Group(PCWG)-3 criteria.\n* Eastern Cooperative Oncology Group (ECOG) PS(Performance Status) of 0 - 2.\n* Minimum life expectancy of 12 weeks.\n* Adequate organ function, defined as follows:\n\n  • Hematological function: Absolute neutrophil count ≥ 1.5 x 10\\^9 \u002FL Platelet count ≥ 100 x 10\\^9\u002FL Hemoglobin \\> 9 g\u002FdL (90 g\u002FL)\n\n  • Coagulation function: Prothrombin Time (PT)\u002FInternational Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) or activated Partial Thromboplastin Time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects undergoing new class anticoagulant therapy (eg, Edoxaban), stable dose for 2 weeks required prior to enrollment.\n\n  • Renal function: estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 or creatinine clearance ≥ 30 mL\u002Fmin as determined by Cockcroft-Gault equation (Cockcroft and Gault 1976)\n\n  • Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN (or \\\u003C5 x ULN for subjects with liver involvement) total bilirubin (TBL) \\\u003C1.5 x ULN (\\\u003C2 x ULN for subjects with liver involvement) (except participants with Gilbert syndrome who must have total bilirubin \\\u003C3.0 mg\u002FdL)\n\n  • Pulmonary function: no clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (eg, PleurX) are allowed baseline oxygen saturation \\>90% on room air\n\n  • Cardiac function: cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings Provision of evaluable tumor samples for central testing (archival or in-study biopsy)\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastases:\n\n  • Subjects with treated brain metastases are eligible provided the following criteria are met:\n* Subject is asymptomatic from brain metastases\n* Whole brain radiation or surgery was completed at least 2 weeks prior to first dose of study treatment (stereotactic radiosurgery completed at least 7 days prior to first dose of study treatment)\n* Any CNS disease is clinically stable, subject is off steroids for CNS disease for at least 5 days (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs at least 14 days prior to first dose of study treatment • Subjects with untreated brain metastases that are asymptomatic and do not require corticosteroids, nor local therapy per investigators standard of practice are allowed Diagnosis or evidence of leptomeningeal disease.\n\nPrior history of immune checkpoint inhibitors resulting in:\n\n* Any severe or life-threatening immune-mediated adverse event, History of immune-mediated encephalitis or other immune-mediated CNS event (any grade)\n* Grade ≥ 2 immune-mediated recurrent pneumonitis, Infusion-related reactions leading to permanent discontinuation of immunotherapy agent Exception: Subjects with a history of immune checkpoint inhibitor-induced endocrinopathy which is clinically stable on replacement therapy.\n\n  * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n  * History of solid organ transplantation.\n  * History of other malignancy within the past 2 years, with the following exceptions:\n* low-risk malignancy treated with curative intent and with no known active disease present for ≥ 1 year before enrollment and believed to be at low risk for recurrence per investigator discretion.\n* adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, cervical carcinoma in situ without evidence of disease, breast ductal carcinoma in situ without evidence of disease.\n* prostatic intraepithelial neoplasia without evidence of prostate cancer. (For non-prostate cancer patient)\n* adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.\n\n  * Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months prior to first dose of study treatment (Section 11.9).\n  * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.\n  * Presence\u002Fhistory of viral infection: Human immunodeficiency virus (HIV) infection\n* Subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines, Active hepatitis C infection (subjects with detectable hepatitis C antibody \\[HCV Ab\\] and HCV RNA viral load above the limit of quantification),\n* Subjects with presence of HCV Ab and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed Active hepatitis B infection (presence of hepatitis B surface antigen \\[HBsAg\\] and hepatitis B virus \\[HBV\\] DNA viral load above the limit of quantification \\[HBV DNA positive\\])\n* Subjects with resolved HBV infection defined as absence of HBsAg and presence of HBV core antibody (anti-HBc) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n* Subjects with chronic HBV infection inactive carrier state defined as presence of HBsAg and HBV DNA viral load below the limit of quantification \\[HBV DNA negative\\] are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n\nReceiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment:\n\n* Prophylactic dexamethasone required by the protocol and any anti-emetic therapies are allowed\n* Low-dose corticosteroids (prednisone ≤10 mg per day or equivalent is permitted during the trial)\n\n  * Subject with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.\n  * Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n  * Prior therapy with tarlatamab\n  * Prior therapy with any selective inhibitor of the DLL3 pathway.\n  * Subject received more than 2 prior systemic therapy regimens for EPNECs. In patients with treatment-emergent prostate neuroendocrine carcinoma, treatments given before histological confirmation of neuroendocrine cancer (e.g., androgen deprivation therapy, androgen receptor targeted agents such as enzalutamide and abiraterone, and docetaxel) are not considered as previous treatment for metastatic\u002Frecurrent EPNEC.\n  * Prior anti-cancer therapy within 21 days prior to first dose of study treatment. Exceptions:\n* Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade ≤ 1, or to levels dictated in the eligibility criteria, before first dose of study treatment, with the exception of alopecia or toxicities considered irreversible (defined as having been present and stable for \\>30 days) which are not otherwise described in the exclusion criteria.\n* Prior palliative radiotherapy must have been completed at least 7 days before the first dose of study treatment.\n\n  * Receiving anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy. Patients who are receiving adjuvant hormonal therapy for resected breast cancer may be eligible (refer also to exclusion related to history of other malignancies). Additionally, in patients with treatment-emergent prostate neuroendocrine carcinoma, continuation of androgen deprivation therapy is permitted.\n  * Any herbal or prescription\u002Fnon-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and\u002For breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.\n\nAny herbal or prescription\u002Fnon-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes (including but not limited to clarithromycin, itraconazole, ketoconazole) within 7 days prior to the first dose of study treatment.\n\n* Any herbal or prescription\u002Fnon-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.\n* Subjects who have reached the limit dose of prior treatment with cardiotoxic drugs such as other anthracyclines.\n* Major surgical procedures within 28 days prior to first dose of study treatment.\n\nTreatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines (eg, non-live or non-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for Monkeypox infection) within 3 days prior to first dose of study treatment.\n\n* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n* Female subjects of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 60 days after the last dose of tarlatamab.\n* Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab\n* Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab\n* Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a serum or urine pregnancy test.\n* Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab.\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab\n* Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab Subject has known sensitivity or is contraindicated to any of the products or components to be administered during dosing\n* Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures\n* History or evidence of any other clinically significant disorder, condition or disease","19 Years",{"count":56,"type":20},60,[58],"PHASE2","This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who have previously received platinum-based first-line chemotherapy. Participants will receive tarlatamab on Cycle 1 Day 1 (C1D1), Day 8 (C1D8), and Day 15 (C1D15), followed by administration every two weeks thereafter. No placebo control is included in this study.",[61,62,29],"Neuroendocrine Carcinomas (NEC)","Neuroendocrine Carcinoma of Pancreas",[64,65,66,67],"extrapulmonary neuroendocrine carcinoma","Tarlatamab","bispecific t-cell engager","DLL3","RECRUITING","2026-04-09",{"date":35,"type":38},{"date":72,"type":38},"2025-09-02",{"date":74,"type":20},"2029-04-30",{"name":76,"class":44},"Inkeun Park",4]