[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Phanes Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,72],{"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":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100472391","phase-1-dose-escalationexpansion-study-of-mavrostobart-pt199-an-anti-cd73-mab-administered-alone-and-in-combination-with-a-pd-1-inhibitor-or-chemotherapy-the-morningstar-study-100472391",false,"NCT05431270","Dose Escalation\u002FExpansion Study of Mavrostobart (PT199), an Anti-CD73 mAb, Administered Alone and in Combination With a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study)","A Phase 1, Open-Label, Dose Escalation and Expansion Study of Mavrostobart (PT199) Administered Alone in Adult Patients With Advanced Solid TuMORs, in CombiNation With a Checkpoint INhibitor TreatinG Wild-type Non-Small Cell Lung Cancer, or in Combination With ChemoTherapy for Metastatic or Advanced PAncreatic Ductal AdenocaRcinoma (MORNINGSTAR)","Key Inclusion Criteria\n\n1. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.\n2. For Part A: a histologically or cytologically confirmed unresectable advanced or metastatic solid tumors previously treated with therapies, or for which treatment is not available or not tolerated.\n\n   For Part B: A histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutations and radiological documentation of disease progression on prior treatments, which may include a checkpoint inhibitor, or patients diagnosed with metastatic and\u002For advanced (m\u002Fa) PDAC who have disease progression after previously treated with therapies, or for which treatment is not available or not tolerated.\n\n   For Part C: A histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations such as EGFR or ALK mutations and radiological documentation of disease progression on prior treatments, which may include a checkpoint inhibitor.\n\n   For Part D:\n   * Cohort D1: a histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC), treatment naïve for advanced or metastatic disease, and eligible to receive standard of care treatment with gemcitabine plus nab-paclitaxel.\n   * Cohort D2: a histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutations and radiological documentation of disease progression on prior treatments, which may include a checkpoint inhibitor. Patients have progressed under first-line (1L) SOC chemotherapy with or without ICI or later lines of therapy, or for which standard 1L therapy has proven to be ineffective, intolerable, or is considered inappropriate.\n   * Cohort D3: a histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutations. Patients are treatment naïve and have no contra indication to receive carboplatin plus pemetrexed.\n   * Cohort D4: a histologically or cytologically confirmed diagnosis of NSCLC without actionable genomic alterations (AGAs) such as EGFR or ALK mutations. Patients are treatment naïve and are eligible for 1L therapy with pembrolizumab and carboplatin plus pemetrexed.\n3. In all Parts, should be able to provide a tumor tissue sample (archival or newly acquired biopsy) to be assessed for CD73 and other biomarkers (PD-L1), unless deemed by the Investigator to cause risk to the patient or per Investigator's discretion.\n4. ECOG performance status of 0 or 1.\n5. Adequate organ function confirmed at screening and within 72 hours of initiating 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. Active autoimmune disease or a history of autoimmune diseases that may relapse.\n4. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment.\n5. Patients who have experienced Grade ≥ 3 immune-related events, such as (non-infectious) pneumonitis, interstitial lung disease, myocarditis.\n6. Patients with untreated brain or central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed.\n7. Impaired cardiac function or significant diseases.\n8. Patients who have ≥ Grade 3 neuropathy.\n9. Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy.\n10. Patients who are currently receiving (last dose within 5 days from C1D1) treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.\n\nAdditional inclusion and exclusion criteria will apply.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a first-in-human, Phase 1\u002F2, open-label, study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Mavrostobart (PT199) alone and in combination with a PD-1 inhibitor or chemotherapy.",[27,28],"Non Small Cell Lung Cancer","Pancreatic Ductal Adenocarcinoma",[30,31,32,33,34,35],"Advanced","Metastatic","Refractory","Anti-CD73","Checkpoint immunotherapies","PD-1\u002FPD-L1 inhibitors","RECRUITING","2026-05-15",{"date":39,"type":40},"2026-05-19","ACTUAL",{"date":42,"type":40},"2022-08-11",{"date":44,"type":20},"2028-08",{"name":46,"class":47},"Phanes Therapeutics","INDUSTRY",6,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100476358","phase-1-spevatamig-pt886-as-monotherapy-or-in-combination-with-chemo-andor-ici-for-the-treatment-of-patients-with-advanced-gastric-gastroesophageal-junction-pancreatic-ductal-or-biliary-tract-carcinomas-the-twinpeak-study-100476358","NCT05482893","Spevatamig (PT886) as Monotherapy or in Combination With Chemo and\u002For ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)","A Phase 1\u002F2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and\u002For an Immune ChecKpoint Inhibitor. The TWINPEAK Study","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. 3\\. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated.\n\n   Part C, Cohort C1: 2L m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible.\n\n   Part C, Cohort C2: 1L m\u002Fa PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).\n\n   Part C, Cohort C3: 1L m\u002Fa PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX\u002FmFFX.\n\n   Cohort C4: Patients with m\u002Fa BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment.\n\n   Cohort C5: Patients with m\u002Fa HER2 negative GC\u002FGEJC and present a PD-L1 CPS score of \\\u003C1%, who are treatment naïve for their m\u002Fa disease and eligible for treatment with SOC chemotherapy (mFOLFOX6 or CAPOX).\n\n   Part D, Cohort D2: Patients with m\u002Fa GC\u002FGEJ-C, that have progressed under 1L SOC chemotherapy, and zolbetuximab, will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).\n\n   Part D, Cohort D3: 2L or 3L m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).\n\n   Part D, Cohort D4: 1L HER2 negative m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).\n4. Biopsies:\n\n   Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers.\n\n   Parts C and D: Patients must present with ≥ 10%; ≥ 2+ CLDN18.2 positive TC in their tumor tissue.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function confirmed at screening and within 72 hours of initiating treatment.\n\nKey Exclusion Criteria\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Women who are pregnant or lactating.\n2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.\n3. Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment.\n5. Patients with a history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or have a history of interstitial lung disease. History of COVID-19 pneumonia with fibrotic changes.\n6. Patients with untreated brain or central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain\u002FCNS metastases).\n7. Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. For Part D, Cohort D2, prior treatment with zolbetuximab is allowed.\n8. Impaired cardiac function or significant diseases.\n9. Prior hemolytic anemia or Evans Syndrome in the last 3 months.\n10. Active gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention.\n11. Patients who have experienced any thromboembolic event such as deep vein thrombosis (DVT) or pulmonary embolism in the past 6 months.\n\nAdditional inclusion and exclusion criteria will apply.",{"count":57,"type":20},258,[23,24],"This is a first-in-human, Phase 1\u002F2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig (PT886). Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, biliary tract carcinoma (BTC) and pancreatic ductal adenocarcinoma (PDAC).",[61,28,62],"Gastric or Gastroesophageal Junction Adenocarcinoma","Biliary Tract Cancer (BTC)","2025-10-31",{"date":65,"type":40},"2025-11-04",{"date":67,"type":40},"2023-03-15",{"date":69,"type":20},"2028-04",{"name":46,"class":47},11,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":112,"locationsCount":113},"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":80,"type":20},203,[23,24],"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.",[84,85,86,87,88,89],"Small Cell Lung Cancer (SCLC)","Large Cell Neuroendocrine Cancer (LCNEC)","Neuroendocrine Prostate Cancer (NEPC)","Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)","Neuroendocrine Carcinomas (NEC)","Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)",[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"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","2025-09-18",{"date":108,"type":40},"2025-09-23",{"date":110,"type":40},"2023-09-05",{"date":44,"type":20},{"name":46,"class":47},12,""]