[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-prostate-cancer-nepc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-prostate-cancer-nepc":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,83,109],{"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":46},"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",false,"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.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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",[26,27,28,29],"Small Cell Lung Cancer (SCLC )","Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)","Gastroenteropancreatic NEC (GEP NEC)","Neuroendocrine Prostate Cancer (NEPC)",[31,32,33],"Neuroendocrine carcinoma","DLL3","CAR T","NOT_YET_RECRUITING","2026-06-22",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":20},"2026-06",{"date":42,"type":20},"2030-08",{"name":44,"class":45},"Moonlight Bio, Inc","INDUSTRY",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100643338","phase-2-sacituzumab-tirumotecan-in-pts-w-nepc-after-progression-on-prior-chemotherapy-100643338","NCT07639086","Sacituzumab Tirumotecan in Pts w\u002F NEPC After Progression on Prior Chemotherapy","Sacituzumab Tirumotecan in Patients With Neuroendocrine Prostate Cancer After Progression on Prior Chemotherapy","STOP-NEPC","Inclusion Criteria\n\n1. Patients with histologically or cytologically confirmed diagnosis of de novo (d-NEPC) or treatment related NEPC (t-NEPC), defined by one or more of the following: histologically small cell prostate cancer or neuroendocrine differentiation by IHC, defined by positive staining by chromogranin or synaptophysin and\u002For additional neuroendocrine markers. Patients with t-NEPC must have history of treatment with ADT and\u002For an androgen receptor pathway inhibitor (ARPI) agent.\n\n   Note: Pure small cell\u002FNEPC or NEPC mixed with adenocarcinoma or other histologic subtype are eligible\n2. Patients must have progressed following at least one course (minimum of 4 cycles) of platinum-based chemotherapy (alone or in combination with etoposide or taxane). Patients who received prior taxane alone for treatment of mHSPC or mCRPC, and patients who received a checkpoint inhibitor immunotherapy alone or in combination with prior chemotherapy are eligible. Patients who received a non-ADC drug through a prior clinical trial or Tarlatamab are also eligible provided they had also received at least one course of platinum-based chemotherapy.\n3. Patients who have measurable metastatic disease per PCWG modified RECIST 1.1 criteria as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. Patients with radiologically positive pelvic nodal, bone or soft tissue metastatic disease, are acceptable. Progressive disease is defined per PCWG modified RECIST 1.1 criteria.\n\n   Note: Patients who have prior prostatectomy, definitive or salvage radiation, are eligible.\n4. Male participant at least 18 years of age at the time of providing the informed consent.\n5. If capable of producing sperm, the participant agrees to the following during the intervention period and for at least 120 days after:\n\n   * Refrains from donating sperm\n   * Uses a penile\u002Fexternal condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive method (refer to Section 10.4.2), as a condom may break or leak Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.\n6. If capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use a penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate.\n7. The participant (or legally acceptable representative if applicable) provides written informed consent for the study.\n8. Has provided an archival tumor tissue sample collected within 12 months prior to the enrollment or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from prostate or a metastatic site, from which NEPC was diagnosed. Irradiated tissue is not acceptable. Sites should follow local guidelines regarding fresh tissue collection.\n9. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n10. Adequate organ function as defined below. Specimens must be collected within 10 days before the start of study intervention. Any value of serum prostate specific antigen (PSA) is considered eligible.\n11. Absolute neutrophil count ≥1500\u002FµL\n12. Platelets ≥100,000\u002FµL\n13. Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n14. Creatinine clearance ≥30 mL\u002Fmin\n15. Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n16. ALT\u002FAST ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n17. Albumin ≥3.0 g\u002FdLb\n18. INR or PT\u002FaPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants a Criteria must be met without colony-stimulating factors, erythropoietin dependency, and without pRBC transfusion within the preceding 2 weeks.\n\n    b Criteria must be met without albumin supplementation within the last 72 hours.\n19. Has ECOG performance status of 0 or1\n20. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.\n21. HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n    * Having a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n    * Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening\n    * Absence of any AIDS-defining opportunistic infections within the past 12 months\n    * Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before enrollment and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers\u002Finhibitors\u002Fsubstrates. Refer to https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor\u002Fsubstrate of CYP3A4.\n\n    Note: HIV testing at screening is not required unless there is a known history of HIV infection or it is mandated by local guidelines\n22. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before enrollment.\n\n    Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\n    Hepatitis B testing at screening is not required unless there is a known history of HBV infection or it is mandated by local guidelines\n23. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before enrollment. Hepatitis C testing at screening is not required unless there is a known history of HCV infection or it is mandated by local guidelines\n\nExclusion Criteria\n\n1. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n2. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.\n3. Received prior treatment with a TROP2-targeted ADC.\n4. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.\n5. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention. ADT and\u002For antiandrogens\u002FARPI is allowed.\n6. Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and\u002For has had radiation pneumonitis.\n\n   Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n7. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n   Refer to Section 6.2 for information on COVID-19 vaccines.\n8. Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n\n   Note: A list of strong inducers\u002Finhibitors of CYP3A4 can be found at the following website: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor of CYP3A4.\n9. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anticancer therapy is prohibited.\n10. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n11. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n\n    Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n12. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously-treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n13. Has an active infection requiring systemic therapy (except those permitted per Section 5.1)\n14. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n15. Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and\u002For to another biologic therapy.\n16. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n\n    Note: Participants who underwent major surgery must have adequately recovered from toxicity and\u002For complications from the surgery before starting study intervention.\n17. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n18. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc), any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.\n19. Has a \"superscan\" bone scan. This is defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated.","MALE",{"count":57,"type":20},20,[59],"PHASE2","This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.",[62,29],"Prostate Cancer",[64,65,66,67,68,69,70,71],"Neuroendocrine Prostate Cancer","Progression","NEPC","Small Cell Prostate Cancer","Treatment-Emergent NEC Prostate Cancer","Sacituzumab Tirumotecan","TROP2","Platinum-Refractory Prostate Cancer","2026-06-05",{"date":74,"type":38},"2026-06-10",{"date":76,"type":20},"2026-08-31",{"date":78,"type":20},"2032-03-31",{"name":80,"class":81},"Virginia Commonwealth University","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100605613","phase-2-memantine-hydrochloride-in-prostate-cancer-patients-100605613","NCT07164794","Memantine Hydrochloride in Prostate Cancer Patients","A Prospective Study of Memantine Hydrochloride for the Treatment of Prostate Cancer Patients","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed one or two prior lines of therapy. Patients with concomitant Alzheimer's disease will be prioritized for enrollment.\n3. Complete clinical baseline data must be available, and the patient must be willing to undergo long-term follow-up.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nExclusion Criteria:\n\n1. Patients with metastatic prostate cancer at initial diagnosis who have not progressed to mCRPC.\n2. Patients with a concurrent primary malignancy at another site.",{"count":91,"type":20},15,[59],"The goal of this clinical trial is to learn if long-term use of memantine hydrochloride can treat, prevent, or correct castration resistance and drug resistance in advanced prostate cancer. The study will enroll male patients aged 18 and older diagnosed with metastatic castration-resistant prostate cancer (mCRPC) who have previously failed first or second-line treatments. The main questions it aims to answer are:\n\nWhat is the progression-free survival (PFS) in patients treated with memantine hydrochloride? What is the disease control rate (DCR) and what is the change in Prostate-Specific Antigen (PSA) levels after treatment?\n\nResearchers will compare outcomes from participants in this single-arm study to an external historical control group of patients who received traditional treatment to see if the addition of memantine hydrochloride improves prognosis.\n\nParticipants will be asked to do the following:\n\nContinue their standard of care treatment, which includes Androgen Deprivation Therapy (ADT) and a novel endocrine therapy.\n\nTake the study drug, memantine hydrochloride, with the dose gradually increasing over the first three weeks to a maintenance dose.\n\nAttend regular follow-up appointments for blood tests to check PSA levels and undergo imaging scans to monitor the disease status. These follow-ups will occur one month after starting the drug and every three months thereafter.",[95,62,29],"Metastatic Castration-resistant Prostate Cancer (mCRPC)",[97,98,99],"Memantine","mCRPC","Prospective Study","2025-11-15",{"date":102,"type":38},"2025-11-19",{"date":104,"type":20},"2025-11",{"date":106,"type":20},"2028-06",{"name":108,"class":81},"Bin Xu",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"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. NECs that have transformed from NSCLC are not eligible. 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 criteria in Part A, C or D.\n\n   Part C:\n\n   • Cohort 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\n   Cohort C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.\n\n   Part D:\n   * Cohort D1: will include 2L patients with SCLC, LCNEC, pr EP-NEC that have progressed\u002Frelapsed from their first-line treatment that may have included an ICI.\n   * Cohort 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   * Cohort 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.\n2. 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.\n3. ECOG performance status of 0 or 1.\n4. 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.\n4. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2, and excluding ICIs) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment with Peluntamig (PT217).\n5. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications (≥ 10 mg prednisone, or equivalent) within 14 days prior to study drug Peluntamig (PT217), or anticipation of need for systemic immunosuppressive medication during study drug Peluntamig (PT217).\n6. Patients who have experienced Grade ≥ 3 immune-related events, such as (non-infectious) pneumonitis, interstitial lung disease, myocarditis.\n7. Treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment with Peluntamig (PT217).\n8. Patients with untreated brain or central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed.\n\n   Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 14 days are eligible for treatment.\n9. Impaired cardiac function or significant diseases.\n10. For Part D only, uncontrolled hypercalcemia.\n11. For Part D only, significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n12. Prior hemolytic anemia or Evans Syndrome in the last 3 months.\n13. Patients who have Grade ≥ 3 neuropathy.\n14. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants .\n\nAdditional criteria may apply.",{"count":117,"type":20},203,[23,59],"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.",[121,122,29,123,124,27],"Small Cell Lung Cancer (SCLC)","Large Cell Neuroendocrine Cancer (LCNEC)","Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)","Neuroendocrine Carcinomas (NEC)",[32,126,127,128,129,66,130,131,132,133,134,31,135,136,137],"DLL3 expressing tumors","Lung cancer","SCLC","LCNEC","GEP-NEC","Small Cell Lung Cancer","Large cell neuroendocrine cancer","Neuroendocrine prostate cancer","Gastroenteropancreatic neuroendocrine carcinoma","Extrapulmonary neuroendocrine carcinoma","EP-NEC","CD47","RECRUITING","2025-09-18",{"date":141,"type":38},"2025-09-23",{"date":143,"type":38},"2023-09-05",{"date":145,"type":20},"2028-08",{"name":147,"class":45},"Phanes Therapeutics",12]