[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-ductal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-ductal-adenocarcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,86,0,25,[9,44,79,105,133,161,182,220,250,276,307,340,365,387,417,440,477,498,546,570,590,611,667,691,724],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100549007","phase-1-a-clinical-study-of-mk-2870-alone-or-with-other-treatments-to-treat-gastrointestinal-cancers-mk-9999-02a-100549007",false,"NCT06428409","A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)","A Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has one of the following cancers:\n\n  * Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer\n  * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer\n  * Advanced and\u002For unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer\n  * Advanced and\u002For unresectable BTC and has not received prior therapy for the cancer\n* For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of severe eye disease\n* For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening","ALL","18 Years",{"count":20,"type":21},220,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:\n\n* About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it\n* How many people have the cancer respond (get smaller or go away) to treatment",[28,29,30],"Colorectal Cancer","Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2024-06-20",{"date":39,"type":21},"2029-10-16",{"name":41,"class":42},"Merck Sharp & Dohme LLC","INDUSTRY",55,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100532907","phase-1-phase-1-study-to-investigate-tcrts-kras-mutation-in-unresectable-advanced-andor-metastatic-solid-tumors-100532907","NCT06218914","Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor\n* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\\*08:02 positive, HLA-A\\*11:01 or HLA-A\\*11:02 positive in at least one allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Presence of at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n\nKey Exclusion Criteria:\n\n* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment\n* Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.",{"count":52,"type":21},108,[24],"Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and\u002For Metastatic Solid Tumors.",[56,57,29,58,59,60],"Non-small Cell Lung Cancer","Colorectal Carcinoma","Endometrial Cancer","Solid Tumor, Adult","KRAS G12D",[62,63,60,64,65,66,28,67,29,68,69,70],"TCR-T cell therapy","KRAS","Autologous","PDAC","NSCLC","Solid tumors","HLA-C*08:02","HLA-A*11:01","HLA-A*11:02",{"date":34,"type":35},{"date":73,"type":35},"2024-03-22",{"date":75,"type":21},"2043-11-18",{"name":77,"class":42},"AstraZeneca",18,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":83,"conditions":89,"keywords":92,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100645104","phase-1-a-study-of-gfh276-combined-with-cetuximab-or-chemotherapy-in-participants-with-solid-tumors-and-pancreatic-ductal-adenocarcinoma-pdac-harboring-ras-mutation-100645104","NCT07678593","A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","A Multi-center, Open-label Phase Ib\u002FII Study Exploring the Safety\u002FTolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification\n3. At least one measurable lesion according to RECIST v1.1\n4. ECOG performance status 0 or 1\n5. Life expectancy \\> 3 months\n6. Adequate organ function\n7. Willing to provide written informed consent\n8. Fertile participants must use effective contraception\n\nExclusion Criteria:\n\n1. Other active malignancy within 3 years\n2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor\n3. History of active clinically significant cardiovascular dysfunction\n4. For participants with known concomitant second oncodriver for PDAC or for solid tumors.\n5. With active infection (HIV, HBV, HCV, syphilis)\n6. The presence of clinical or radiological evidence of intestinal obstruction.\n7. Prior anticancer therapy within 28 days or 5 half-lives\n8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months\n9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.\n10. History of central nervous system (CNS)disease\n11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.\n12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.",{"count":87,"type":21},222,[24,25],[90,29,91],"Advanced Solid Tumors Cancer","RAS Mutation",[93,65,91,94],"GFH276","solid tumors","NOT_YET_RECRUITING","2026-06-24",{"date":34,"type":35},{"date":99,"type":21},"2026-09",{"date":101,"type":21},"2028-09",{"name":103,"class":42},"Genfleet Therapeutics (Shanghai) Inc.",3,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":132},"100436960","pancreatic-cancer-early-detection-consortium-100436960","NCT04970056","Pancreatic Cancer Early Detection Consortium","PRECEDE","Inclusion Criteria:\n\nIndividuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:\n\nCohort 1\n\nIndividuals without history of PDAC meeting any of the following criteria:\n\n1. 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.\n2. 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family\n3. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family\n4. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+\n5. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+\n6. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+\n\nCohort 2\n\nIndividuals without history of PDAC meeting any of the following criteria:\n\n1. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+\n2. 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family\n3. 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member\n\nCohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)\n\nCohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.\n\nCohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and\u002For buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.\n\nCohort 6a\n\nIndividuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:\n\n1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other\n2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11\n\nCohort 6b\n\nIndividuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:\n\n1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other\n2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11\n3. Diagnosed ≤ age 45\n\nCohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.\n\nCohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.\n\nCyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)\n\nExclusion Criteria:\n\n* Individuals not meeting the criteria above.",true,"90 Years",{"count":115,"type":21},20000,"OBSERVATIONAL","The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and\u002For individuals carrying pathogenic\u002Flikely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.",[119,120,29,121],"Pancreas Cancer","Pancreas Cyst","Genetic Predisposition","2026-06-23",{"date":124,"type":35},"2026-06-26",{"date":126,"type":35},"2020-09-18",{"date":128,"type":21},"2030-12-31",{"name":130,"class":131},"Arbor Research Collaborative for Health","OTHER",60,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100626207","phase-1-18ffpyqcp-pet-imaging-of-fibroblast-activation-protein-in-selected-oncology-indications-100626207","NCT07432633","[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","A Phase 1\u002F2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","Inclusion Criteria:\n\n1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.\n2. Participants must be ≥ 18 years and \\\u003C 80 years of age and competent to give informed consent.\n3. Eastern Cooperative Oncology Group performance status ≤ 2.\n4. Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).\n5. Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET\u002FCT imaging visit (Visit 2) prior to \\[18F\\]FPyQCP administration.\n6. WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study\n7. Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease \\[5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of \\[18F\\]FPyQCP administration.\n8. Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before \\[18F\\]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.\n9. Either:\n\n   1. Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42.\n   2. Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42. \\[18F\\]FPyQCP PET\u002FCT imaging should be performed as close to scheduled procedure as clinically feasible.\n   3. Suspected recurrence after definitive therapy\n\nExclusion Criteria:\n\n1. Participants administered any radioisotope within 5 physical half-lives prior to \\[18F\\]FPyQCP administration.\n2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to \\[18F\\]FPyQCP administration.\n3. Participants who have recently received any other contrast agent (\\\u003C 24 hours for intravenous agents and \\\u003C 5 days for oral agents) before the day of \\[18F\\]FPyQCP administration.\n4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.\n5. Known hypersensitivity to \\[18F\\]FPyQCP or any of its constituents.\n6. Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.\n7. Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgment, excluding disorders directly related to the index cancer (e.g. tumor-associated pancreatitis or biliary stasis for PDAC).\n8. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.\n9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgment.\n10. Significant renal or hepatic impairment.\n11. Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \\[18F\\]FPyQCP administration.\n12. Cohort A Specific Exclusion Criteria: 12. No prior history of any other cancer, unless treated with curative-intent and disease-free for at least 5 years before Visit 1 (at least 1 year before Visit 1 for basal cell carcinoma, localized squamous cell carcinoma of the skin and in situ carcinoma of cervix).","80 Years",{"count":142,"type":21},71,[24,25],"This is a multi-center, open-label, single-arm, Phase 1\u002F2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \\[18F\\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).",[28,146,147,148,29],"Epithelial Ovarian Cancer","Gastric Cancer","Invasive Lobular Breast Carcinoma",[150,151],"Positron emission tomography","Fibroblast activation protein","2026-06-22",{"date":122,"type":35},{"date":155,"type":35},"2026-02-19",{"date":157,"type":21},"2028-01-31",{"name":159,"class":42},"Blue Earth Diagnostics",1,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":160},"100520733","phase-2-durvalumab-and-oleclumab-in-resectable-pdac-100520733","NCT06060405","Durvalumab and Oleclumab in Resectable PDAC","Durvalumab and Oleclumab in Resectable PDAC: A Window of Opportunity Study (DORA Trial)","DORA","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Weight ≥ 35 kg\n* Have a life expectancy ≥ 12 weeks\n* Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Upfront resectable PDAC\n* Have adequate organ and marrow function required for the study\n* Baseline images taken prior to treatment must undergo central review\n* Participants must agree to use study approved methods to prevent pregnancy for study required period\n\nExclusion Criteria:\n\n* Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment\n* Prior receipt of any immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1 including durvalumab antibodies and agents targeting CD73, CD39, or adenosine receptors, excluding therapeutic anticancer vaccines.\n* Concurrent enrolment in another therapeutic clinical study. Enrolment in observational studies will be allowed.\n* Have a history of Grade 3 or greater thromboembolic events in the prior 3 months or thromboembolic event of any grade with ongoing symptoms.\n* Have prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment.\n* Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment with the following exceptions\n\n  * Vitiligo or alopecia\n  * Hypothyroidism not requiring systemic treatment or stable on hormone replacement\n  * Psoriasis not requiring systemic treatment\n  * Any chronic skin condition that does not require systemic therapy\n* Have known active hepatitis infection. Participants with a past or resolved Hepatitis B (HBV) infection are eligible. Participants positive for Hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection\n* Other invasive malignancy within 5 years.\n* Known allergy or hypersensitivity to investigational product formulations.\n* Active grade 3 or greater edema\n* Uncontrolled intercurrent illness\n* Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment with the following exceptions:\n\n  * Intranasal, topical, inhaled corticosteroids or local steroid injections\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or equivalent\n  * Steroids as premedication for hypersensitivity reaction\n* Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment\n* Major surgery within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery. Local are allowed, without needing to wait for the 28 day recovery period.\n* Are pregnant, lactating, or intend to become pregnant during their participation in the study\n* Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results",{"count":170,"type":21},22,[25],"This is a multi-site Canadian, window of opportunity study to evaluate the immune activity of durvalumab and oleclumab in resectable pancreatic ductal adenocarcinoma (PDAC) when given prior to surgery.",[29],"2026-06-19",{"date":122,"type":35},{"date":177,"type":35},"2023-11-29",{"date":179,"type":21},"2026-10-30",{"name":181,"class":131},"University Health Network, Toronto",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":194,"conditions":195,"keywords":202,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100636166","phase-3-atebimetinib--gnp-as-a-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100636166","NCT07562152","Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)","MAPKeeper 301","Inclusion Criteria:\n\n* Must be ≥18 years of age\n* Must have confirmed diagnosis according to AJCC staging as follows:\n\n  * Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants must be treatment naive as follows:\n\n  * First-line PDAC participants will have received no previous systemic anti-cancer therapy\n* Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria\n* Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values\n\nExclusion Criteria:\n\n* Inability to swallow oral medications\n* Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma\n* Participants with only locally advanced disease\n* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases",{"count":191,"type":21},510,[193],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.",[196,197,65,198,29,199,200,201],"Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Adenocarcinoma Metastatic","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma",[203,204,205,206,207,208,209,210],"mitogen-activated protein kinase (MAPK)","MAPK","MEK","metastatic cancer","gemcitabine","nab-paclitaxel","nab-p","atebimetinib","2026-06-18",{"date":152,"type":35},{"date":214,"type":21},"2026-06",{"date":216,"type":21},"2029-02",{"name":218,"class":42},"Immuneering Corporation",19,{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100561158","phase-1-moonray-01-a-study-of-ly3962673-in-participants-with-kras-g12d-mutant-solid-tumors-100561158","NCT06586515","MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors","A Phase 1a\u002F1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors","MOONRAY-01","Inclusion Criteria:\n\n* Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and\u002For metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA\n* Have an ECOG performance status of ≤ 1\n* Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease\n* Participants with asymptomatic or treated CNS disease may be eligible.\n\nExclusion Criteria:\n\n* Have known active CNS metastases and\u002For carcinomatous meningitis.\n* Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.\n* Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction.\n* Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.\n* Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).\n* Have other active malignancy unless in remission with life expectancy greater than (\\>) 2 years.",{"count":229,"type":21},630,[24],"The main purpose of this study is to assess safety \\& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.",[29,56,28],[60,63,234,235,208,236,237,238,239,240],"LY3962673","Cetuximab","Gemcitabine","Oxaliplatin","Leucovorin","Irinotecan","5-fluorouracil","2026-06-17",{"date":211,"type":35},{"date":244,"type":35},"2024-09-12",{"date":246,"type":21},"2029-03",{"name":248,"class":42},"Eli Lilly and Company",52,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":160},"100465885","liquid-biopsy-and-pancreas-cancer-detection-of-axl-ctcs-ctc-axl-panc-100465885","NCT05346536","Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) CTCs (CTC-AXL-PANC)","Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) Functional CTCs Using EPIDROP","CTC-AXL-PANC","Inclusion Criteria:\n\n* The patient is at least 18 years old;\n* Patients with pancreatic cancer with remote metastases, naïve of any treatment, that is, eligible for a first line of treatment;\n* Patients with oral consent\n\nExclusion Criteria:\n\n* Non-affiliation or non-beneficiary of a Social Security regimen;\n* Frailty persons according to Article L1121-6 of the CSP;\n* Adult protected or unable to give consent as per Article L1121-8 of the CPMP;\n* Pregnant or lactating women as per MSC L1121-5.\n* Not included for monitoring difficulties (mutation, insufficient motivation, predictable poor compliance, priority associated pathology in care, etc.)",{"count":259,"type":21},63,[261],"NA","In solid cancers, some more aggressive tumor cells actively detach from the primary lesion and then travel through the circulating compartment to reach distant organs and form micro-metastases. These circulating tumor cells (CTCs) that have become disseminated tumor cells (DTCs) flourish in their new environments and may remain dormant for many years after the complete resection of the primary tumor. Detecting CTCs in the blood is also relevant for assessing tumor progression, prognosis and therapeutic follow-up. The non-invasive, highly sensitive for CTCs analysis is called \"liquid biopsy\". Pancreatic adenocarcinoma and breast cancer remain among cancers of very poor prognosis and thus represent a major therapeutic challenge. In recent years, the Axl membrane tyrosine kinase receptor has been the target of growing interest. Activation of the Gas6\u002FAxl signaling pathway is associated with, among other things, tumor cell growth and survival, epithelial to mesenchymal transition (EMT) or drug resistances. In addition, Axl overexpression is frequently identified in patients with pancreatic adenocarcinoma and is associated with a poor prognosis. For example, the Laboratoire des Cellules Circulantes Rares Humaines (LCCRH) at the CHU and the University of Montpellier has developed two new \"CTC-AXL\" tests to detect CTCs expressing Axl: one using the CellSearch® (gold standard and FDA-approved) system and the other using the EPIDROP technique. The purpose of this research project is to assess the concordance of the \"CTC-AXL\" measurement by the innovative EPIDROP technique and the CellSearch® technique in patients with metastatic pancreatic or breast cancer.",[29,264,265],"Metastatic Pancreatic Cancer","Circulating Tumor Cell",[264,265,267,268],"AXL","CellSearch",{"date":152,"type":35},{"date":271,"type":35},"2022-06-16",{"date":273,"type":21},"2027-12-31",{"name":275,"class":131},"University Hospital, Montpellier",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":293,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100613057","phase-1-phase-i-study-of-177lulu-dfc413-in-patients-with-solid-tumors-100613057","NCT07261631","Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors","A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years with one of the following indications:\n* Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic HR+\u002FHER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to, immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy\n* (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy\n* Patients must have lesions showing 68Ga-NNS309 uptake\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL, hemoglobin \\\u003C 9 g\u002FdL, or platelet count \\\u003C 100 x 109\u002FL\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2, calculated using CKD-EPI 2021 or measured\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy\n* Any prior radioligand therapy\n* Radiation therapy within 4 weeks prior to the first dose of \\[177Lu\\]Lu-DFC413\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":285,"type":21},180,[24],"The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[177Lu\\]Lu-DFC413 and safety and imaging properties of \\[68Ga\\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors",[29,289,290,291,28,292],"Non-Small Cell Lung Cancer","HR+\u002FHER2- Ductal and Lobular Breast Cancer","Triple Negative Breast Cancer","Soft Tissue Sarcoma",[65,66,294,295,296,297],"Breast cancer","CRC","STS","Radioligand therapy (RLT)","2026-06-16",{"date":241,"type":35},{"date":301,"type":35},"2025-11-24",{"date":303,"type":21},"2029-05-09",{"name":305,"class":42},"Novartis Pharmaceuticals",8,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":321,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":339},"100609796","phase-2-study-to-evaluate-the-diagnostic-performance-of-geh300079-68ga-injection-petct-for-detection-of-pc-in-patients-with-colorectal-gastric-ovarian-or-pancreatic-cancers-periscope-100609796","NCT07219238","Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET\u002FCT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)","A Phase 2\u002F3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)\u002FComputed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)","Inclusion Criteria:\n\n* Participant is ≥18 years of age\n* Participant has provided signed informed consent before any study-specific screening procedures\n* Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC\n* Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings.\n* Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 ( 68Ga) PET\u002FCT Imaging Visit\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Participant is able and willing to comply with all study procedures as described in the protocol\n\nExclusion Criteria:\n\n* Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening up to 30 days after receiving the investigational medicinal product (IMP)\n* Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures\n* Participant needs any intervention that would delay study participation\n* Participant has non-resectable extra-abdominal metastasis and\u002For \\>3 hepatic metastases on standard work up\n* Participant will not be able to complete the study, based on their anticipated life expectancy\n* Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted)\n* Participant has renal function impairment as defined by:\n\n  1. For Phase 2: estimated glomerular filtration rate less than 60 mL\u002Fmin\n  2. For Phase 3: estimated glomerular filtration rate less than 30 mL\u002Fmin\n* Participant has severe hepatic function impairment as defined by:\n\n  1. Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) and alanine aminotransferase (serum glutamic-pyruvic transaminase): ≤2.5 × upper limit of normal (ULN; ≤5 × ULN for participants with liver metastases)\n  2. Bilirubin: ≤1.5 × ULN or direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n* Participant has autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Participant has serious co-morbidities or serious non-malignant disease that in the opinion of the investigator, could compromise participant safety and\u002For protocol objectives\n* Participant either received or is planning to receive any other investigational agent within the 28 days prior to the first imaging visit or during study participation (with the exception of the 3-month follow-up period)\n* Participant has known or suspected hypersensitivity to any excipients used in GEH300079 (68Ga)\n* Participant has severe claustrophobia, is unable to lie flat or fit into the scanner, or is unable to tolerate the PET\u002FCT scan for any reason\n* (Phase 3 only) Participant was previously included in Phase 2 of this study",{"count":315,"type":21},175,[25,193],"This study is a Phase 2\u002F3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET\u002FCT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET\u002FCT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study.\n\nThe study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET\u002FCT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET\u002FCT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.",[28,319,320,29],"Gastric Cancers","Ovarian Cancers",[322,323,324,325,326,327,328,329,330,331],"Peritoneal Carcinomatosis (PC)","Pancreatic Cancers","Colorectal cancer","Gastric cancer","FAPI","Ovarian cancer","68Ga","PET\u002FCT imaging","Diagnostic imaging","Diagnostic performance",{"date":241,"type":35},{"date":334,"type":21},"2026-10",{"date":336,"type":21},"2029-08",{"name":338,"class":42},"GE Healthcare",2,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":78},"100586941","phase-1-study-for-azd4360-in-participants-with-advanced-solid-tumours-100586941","NCT06921928","Study for AZD4360 in Participants With Advanced Solid Tumours","A Phase I\u002FII Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Participant must be ≥ 18 at the time of signing the ICF.\n2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n3. Minimum life expectancy of 12 weeks in the opinion of the Investigator.\n\n4 Adequate organ and marrow function, as defined by protocol.\n\n5\\. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.\n\n6\\. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G\u002FGEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.\n\n7\\. Participants must have received at least one prior line of systemic therapy in the advanced\u002Fmetastatic disease.\n\n8\\. At least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G\u002FGEJC participants.\n2. Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n3. Participants with clinically significant ascites that require drainage.\n4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.\n5. With spinal cord compression or with high risk of paralysis.\n6. History of non-infectious interstitial lung disease\u002Fpneumonitis.\n7. Participant has cardiac abnormalities, as defined by protocol.\n8. History of another primary malignancy within 2 years prior to screening.\n9. Known serologic status reflecting active hepatitis B or hepatitis C.\n10. Known HIV infection that is not well controlled.\n11. Active tuberculosis infection.","130 Years",{"count":349,"type":21},117,[24,25],"The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.",[147,353,30,29],"Gastroesophageal Junction Cancer",[147,353,30,29,355,356,357],"Advanced Solid Tumours","AZD4360","Claudin 18.2","2026-06-15",{"date":298,"type":35},{"date":361,"type":35},"2025-04-29",{"date":363,"type":21},"2027-12-16",{"name":77,"class":42},{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":160},"100608300","phase-2-maintenance-combinatorial-myeloid-immunotherapy-for-unresectable-pancreatic-cancer-100608300","NCT07199764","Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer","IGNITE: A Phase 2 Study of Maintenance Combinatorial Myeloid Immunotherapy in Patients With Unresectable Pancreatic Ductal Adenocarcinoma","IGNITE","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent\n* Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is either locally advanced and unresectable, or metastatic\n* Have received a minimum of 16 and no more than 32 weeks of a first line chemotherapy-based standard of care regimen, resulting in either a PR or SD with no evidence of progression within 14 days prior to first dose of study treatment.\n\n  o Note: Patients must demonstrate at least stable disease (SD) or partial response (PR) by imaging. A single assessment showing PR at the end of chemotherapy (up to 32 weeks) is sufficient; confirmation is not required. If chemotherapy was discontinued between 16-32 weeks due to legitimate medical reasons (as determined by the investigator), the patient may still be eligible if they demonstrated SD or PR prior to discontinuation.\n* Have resolution of all chemotherapy-related toxicities to pre-treatment levels with exception of alopecia (which can be ongoing) and neuropathy (which can be ≤ Grade 2).\n* Eastern Cooperative Oncology (ECOG) performance status of 0 to 1.\n* Measurable disease per RECIST v1.1 (Section 17.2) is a requirement for study entry.\n* Willingness to undergo pre-treatment and on-treatment tumor biopsies. Tumor biopsies are mandatory for all patients with accessible disease, unless determined to be medically infeasible by the investigator.\n* Adequate organ function confirmed by the following laboratory values obtained ≤14 days prior to first administration of study treatment on Day 1:\n\n  * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n  * Platelets ≥100 x 109\u002FL\n  * Hemoglobin ≥9 g\u002FdL\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN); if liver metastases, then ≤5 x ULN\n  * Total bilirubin ≤1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert's syndrome, then ≤2.5 x ULN\n  * Estimated glomerular filtration rate (GFR) (CLCr) ≥45 mL\u002Fmin using Cockcroft Gault formula\n* Females of childbearing potential \\[defined as a sexually mature woman who (1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time during the preceding 24 consecutive months)\\] must:\n\n  * Have a negative serum or urine pregnancy test (β-human chorionic gonadotropin, β-hCG) as verified by the study investigator within 14 days prior to study treatment.\n  * Commit to complete abstinence from heterosexual contact or agree to use medical doctor-approved contraception throughout the study without interruption while receiving study treatment and for at least 120 days following last dose of study treatment.\n* Males must practice complete abstinence or agree to use a condom (even if he has undergone a successful vasectomy) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 120 days following last dose of study treatment.\n\nExclusion Criteria:\n\n* Prior exposure to CD40 antibodies or any other immunomodulatory agent for the treatment of cancer\n* Prior exposure to odetiglucan\n* Received any systemic treatment for pancreatic adenocarcinoma within 14 days prior to the first dose of study therapy. For investigational agents, patients must not have had treatment within a time interval less than at least 5 half-lives of the investigational agent prior to the first scheduled day of dosing in this study\n* Had any active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years, or currently requires systemic therapy with disease-modifying agents, corticosteroids, or immunosuppressive drugs. Examples include but are not limit to: rheumatoid arthritis, systemic sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g. Granulomatosis with polyangiitis, formerly Wegener's Granulomatosis), multiple sclerosis, inflammatory bowel disease, or motor neuropathies of autoimmune origin (e.g. Guillain-Barre Syndrome)\n\n  o Note: Patients are permitted to enroll if they have vitiligo or resolved childhood asthma\u002Fatopy, hypothyroidism stable on hormone replacement, controlled asthma, psoriasis not requiring systemic treatment, Type I diabetes, Graves' disease, or Hashimoto's disease, or with medical monitor approval.\n* An ongoing or active infection requiring intravenous antibiotics, antivirals, or antifungals during the 14 days prior to first dose of study drug\n* An uncontrolled concurrent illness, symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, or cardiac arrhythmia\n* History of (non-infectious) pneumonitis that required steroids, current pneumonitis, or a history of interstitial lung disease\n* QT interval corrected for heart rate using Fridericia's (QTcF) method \\>450 msec for males and \\>460 msec for females\n* A history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months of the first dose of investigational agent\n* A history of human immunodeficiency virus (HIV), hepatitis B (HB), or hepatitis C, except for the following:\n\n  * Patients with anti-HB core antibody but with undetectable HB virus deoxyribonucleic acid (DNA) and negative for HB surface antigen\n  * Patients with resolved or treated hepatitis C virus (HCV) (i.e. HCV antibody positive but undetectable HCV RNA)\n* Received concurrent or prior use of an immunosuppressive agent within 14 days of the first dose of investigational agent, with the following exceptions and notes:\n\n  * Systemic steroids at physiologic doses (equivalent to dose of 10 mg oral prednisone) are permitted\n  * Intranasal, inhaled, topical intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted\n* Patients must not have known, symptomatic brain or leptomeningeal metastases\n* Major surgical procedure within 21 days prior to first dose of study drug. Non-study related minor surgical procedures requiring local\u002Fepidural anesthesia must be completed at least 72 hours before study drug administration. In all cases, patients must be sufficiently recovered and stable before treatment administration\n* Other malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancer; or any other cancer from which the patient has been disease-free for at least 3 years\n* Received a live vaccine within 28 days before the first dose of study drug. If enrolled, patients should not receive live vaccines during the study or for 28 days after the last dose of study treatment (Note: seasonal influenza vaccines for injection are generally inactivated and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed)\n* Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate\n* Known alcohol or drug abuse\n* Any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent",{"count":374,"type":21},100,[25],"Phase II, open-label, single-arm study of CD40\u002FDectin-1 immunotherapy as maintenance treatment in patients with unresectable pancreatic ductal adenocarcinoma (PDA) who have not progressed following 4-8 months of first line (1L) chemotherapy.",[29],"2026-06-08",{"date":380,"type":35},"2026-06-10",{"date":382,"type":35},"2025-11-25",{"date":384,"type":21},"2028-12",{"name":386,"class":131},"University of Pennsylvania",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":339},"100643672","phase-2-a-phase-ii-study-of-gv20-0251-in-combination-with-anti-pd-1-monoclonal-antibodies-in-patients-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100643672","NCT07623642","A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.","An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.\n2. Able and willing to participate in and comply with study procedures throughout the study.\n3. Age ≥ 18 and ≤ 80 years, any gender.\n4. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.\n5. Must have failed standard of care (SOC), be intolerant to SOC, or be deemed by the investigator to be unsuitable for a specific form of SOC. If SOC failure, documented progression from SOC is required.\n6. No more than 2 prior lines of systemic therapy. Subjects with more lines may be enrolled after sponsor approval. Treatment-naive subjects with locally advanced or metastatic melanoma who have not received systemic therapy may enroll.\n7. Tumor types include: endometrial cancer, cervical cancer, ovarian cancer, triple-negative breast cancer, prostate cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma (HCC), biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; excluding ampullary carcinoma), pMMR\u002FMSS colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer, and melanoma (assessed per local institutional standard practice).\n8. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.\n9. If the subject has received prior anti-PD-1\u002FPD-L1 therapy, documented disease progression during treatment with anti-PD-1\u002FPD-L1 monoclonal antibody (as monotherapy or combined with other checkpoint inhibitors\u002Ftherapies) is required.\n10. Eligible subjects of childbearing potential (female and male) must agree to use effective contraception (hormonal or barrier method) starting 28 days prior to the first dose of GV20-0251, throughout the treatment period, and for at least 4 months after the last dose.\n11. Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.\n12. Must provide archival tumor tissue collected within 3 years prior to signing the ICF. If archival tissue is \\>3 years old, enrollment requires medical confirmation with the sponsor.\n13. ECOG performance status of 0-1 prior to the first dose on C1D1.\n14. Expected survival ≥ 24 weeks.\n15. No history of other primary malignancies, except: (a) a curatively treated malignancy with no active disease for at least 2 years prior to consent and low risk of subsequent relapse; or (b) curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n16. Adequate organ, Hepatic, and Coagulation function at screening.\n17. All adverse events related to prior anticancer therapy have resolved to ≤ Grade 1 (per NCI CTCAE v5.0). For persistent Grade 2 toxicities deemed by the investigator unlikely to resolve, eligibility may be discussed with the sponsor.\n18. For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.\n\nExclusion Criteria\n\n1. Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase\u002Flipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.\n2. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)\n3. Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy \\> 30 Gy within 6 months prior to C1D1.\n4. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.\n5. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy.\n6. History of gastrointestinal perforation and\u002For fistula within 6 months prior to consent; or active gastric\u002Fduodenal ulcer, ulcerative colitis, or other GI conditions the investigator believes may cause bleeding or perforation.\n7. Clinically significant and\u002For uncontrolled cardiac disease, including NYHA Class III or IV heart failure, uncontrolled hypertension (systolic BP \\> 160 mmHg), clinically significant arrhythmia assessed by the investigator to affect study participation safety, or myocardial infarction within 6 months prior to C1D1.\n8. Severe hypersensitivity reaction (≥ Grade 3) to anti-PD-1 monoclonal antibody and\u002For any of its excipients; or prior severe hypersensitivity to biologic therapies that the investigator considers may increase subject risk.\n9. Acute leukemia or chronic lymphocytic leukemia (CLL).\n10. QTcF \\> 470 msec, or history of congenital long QT syndrome, or clinically significant ECG abnormalities (including pericarditis) that the investigator considers may affect subject safety.\n11. Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.\n12. History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or current pneumonitis\u002Finterstitial lung disease.\n13. Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1\n14. HIV infection.\n15. Active HBV or HCV infection\n16. Prior major organ transplantation\n17. Prior autologous or allogeneic bone marrow transplantation.\n18. Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.\n19. Major surgery (excluding diagnostic procedures) or severe trauma within 28 days prior to the first dose of GV20-0251, or currently in recovery that the investigator deems would interfere with the study, or anticipated major surgery during the study.\n20. Received a live or attenuated vaccine within 30 days prior to the first dose.\n21. Requires treatment with interferon-α or related\u002Fsimilar agents within 3 weeks prior to C1D1 or during the entire study period.\n22. Requires more than one paracentesis per 8 weeks to manage ascites; or single ascites drainage volume \\> 1.5 liters within 8 weeks prior to C1D1.\n23. Psychiatric illness or substance abuse disorder (e.g., drug abuse, alcohol dependence) that may interfere with the subject's ability to comply with study requirements.\n24. Other serious non-malignant conditions or laboratory abnormalities that, in the opinion of the investigator and\u002For sponsor, make the subject unsuitable for the study; or other circumstances that the investigator believes may confound study results or prevent the subject from completing the study.\n25. Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.",{"count":395,"type":21},227,[25],"This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.",[399,400,401,402,403,404,405,406,29,407,408],"Uterine Cervical Neoplasms","Triple Negative Breast Neoplasms","Prostatic Neoplasms","Squamous Cell Carcinoma of Head and Neck","Esophageal Squamous Cell Carcinoma","Cholangiocarcinoma","Gallbladder Neoplasms","Colorectal Neoplasms","Carcinoma, Non-Small-Cell Lung","Small Cell Lung Carcinoma","2026-06-04",{"date":378,"type":35},{"date":412,"type":21},"2026-06-02",{"date":414,"type":21},"2029-08-15",{"name":416,"class":42},"GV20 Therapeutics",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":439},"100504714","phase-2-a-study-of-nalirifox-in-combination-with-radiation-therapy-in-people-with-pancreatic-ductal-adenocarcinoma-pdac-100504714","NCT05851924","A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)","Total Neoadjuvant NALIRIFOX Plus Ablative Dose Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n1. Subject has been informed about the nature of the study, has agreed to participate in the study, and has signed the informed consent form before participation in any study-related activities.\n2. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.\n\n   Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, DCIS, stage I prostate cancer, and basal cell or squamous cell carcinoma of the skin.\n3. A multidisciplinary discussion has been undertaken\u002Fplanned which can include (a) discussion with medical\u002Fsurgery oncology, (b) Hepatopancreaticobiliary Disease Management Team conference presentation, (c) direct consultation, with confirmation on consensus plan for TNT strategy and potential for future surgery. This plan needs to be documented in the medical record prior to initiation of treatment.\n4. Male or nonpregnant and nonlactating female aged ≥18 years.\n\n   1. Women of child-bearing potential (i.e., fertile, following menarche, and until becoming postmenopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must test negative for pregnancy at the time of screening on the basis of a urine or serum pregnancy test. Postmenopausal women are defined as those who have had an absence of menstruation for at least 2 years. If necessary, follicle-stimulating hormone results \\>50 IU\u002FL at screening are confirmatory in the absence of a clear postmenopausal history.\n   2. Female subjects of reproductive potential must agree to use two effective methods of birth control during the study and for 9 months after the last dose of study medication.\n   3. Male subjects must agree to use condoms during the study and for 4 months after the last dose of study medication'\n\nDisease-specific inclusion criteria:\n\n1. Histologically or cytologically confirmed PDAC that has not been previously treated.\n2. Radiographically BR or LA PDAC in accordance with the NCCN 2.2021 definition, without evidence of distant metastases by CT.\n3. Inoperable status after surgical exploration due to presence of locally advanced, unresectable disease without metastases, in patients who have recovered from surgery, is allowed.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Hematological, biochemical, and organ function inclusion criteria:\n\n   1. Absolute neutrophil count (ANC) ≥1500\u002Fmm\\^3 without the use of hemopoietic growth factors within 7 days before treatment\n   2. Platelet count ≥100,000\u002Fmm\\^3 .\n   3. International normalized ratio (INR) \\\u003C1.5 unless the patient is receiving anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecularweight heparin or warfarin, whether medically indicated, is permitted.\n   4. Adequate renal function, as evidenced by serum\u002Fplasma creatinine level \\\u003C1.6 mg\u002FdL\n\nExclusion Criteria:\n\n1. Presence of metastatic pancreatic cancer (M1 disease)\n2. Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or who is likely to interfere with the interpretation of the results.\n3. Unwilling or unable to comply with study procedures and\u002For study visits.\n4. Medical co-morbidities, that preclude major abdominal surgery\n5. Histologic diagnosis other than adenocarcinoma; however, adenosquamous variants are acceptable.\n6. Receipt of chemotherapy, prior abdominal radiotherapy, and\u002For definitive resection for pancreatic cancer.\n7. Grade \\>2 neuropathy.\n8. Pregnant and\u002For nursing.\n9. Uncontrolled active infection, which would preclude with the exception of resolving cholangitis which in the investigator opinion would render the treatment hazardous.\n10. Known hypersensitivity to any of the components of the chemotherapeutic agents\n11. Receipt of concurrent investigational therapy or within 30 days of protocol initiation.\n\n    Additional criterion for the immunoPET imaging sub-study (n=20)\n12. Previous anaphylactic reaction to human, humanized or chimeric antibody.\n13. Refusal or inability to tolerate the scanning procedure (e.g. due to claustrophobia).",{"count":132,"type":21},[25],"The researchers are doing this study to find out whether using the chemotherapy regimen NALIRIFOX in combination with ablative dose radiation therapy (AD-XRT) and the standard chemotherapy drug capecitabine is an effective treatment approach for people with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) before surgery. This type of treatment approach is called total neoadjuvant therapy (TNT). The researchers will also look at whether the sequence of the treatment approach (NALIRIFOX + ADXRT and capecitabine followed by surgery, when it is possible) is effective and causes few or mild side effects in participants. An important purpose of the study is to see how the study treatment (NALIRIFOX + AD-XRT and capecitabine) affects participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires",[29],[429,430,431],"NALIRIFOX","Ablative Dose Radiation","23-027",{"date":378,"type":35},{"date":434,"type":35},"2023-05-12",{"date":436,"type":21},"2027-05",{"name":438,"class":131},"Memorial Sloan Kettering Cancer Center",7,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":457,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":306},"100570708","phase-1-lead-212-psv359-therapy-for-patients-with-solid-tumors-100570708","NCT06710756","Lead-212 PSV359 Therapy for Patients With Solid Tumors","A Phase I\u002FIIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients With Solid Tumors That Are Known to be Fibroblast Activation Protein (FAP)-Positive","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Satisfactory organ function as determined by laboratory testing\n* Eastern Cooperative Oncology Group performance (ECOG) status of 0 to 1\n* Life expectancy \\> 3 months\n* Progressive disease despite standard therapy or for whom no standard therapy exists\n* Positive \\[203Pb\\]Pb-PSV359 SPECT\u002FCT scan showing uptake of \\[203Pb\\]Pb-PSV359 in at least 1 known lesion on the 1-hour SPECT\u002F CT scan\n* Histological, pathological, and\u002For cytological confirmation of solid tumor malignancy that is locally advanced or metastatic\n\nExclusion Criteria:\n\n* Known hypersensitivity to the active agent or any of the excipients\n* Active secondary malignancy\n* Pregnancy or breastfeeding a child\n* Known brain metastases\n* Known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to enrollment\n* Known medical condition which would make this protocol unreasonably hazardous for the patient\n* Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions\n* Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the investigational product or excipients\n* Major surgery within 21 days prior to the administration of \\[212Pb\\]Pb-PSV359; the subject must be sufficiently recovered and stable before treatment administration\n* Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to enrollment into the study\n* Current abuse of alcohol or illicit drugs\n* Treatment with any live\u002Fattenuated vaccine in the 7 days prior to enrollment\n* Previous treatment with any systemic anticancer therapy within 4 weeks prior to treatment on study",{"count":448,"type":21},112,[24,25],"Phase I\u002FIIa image-guided, alpha-particle therapy study of \\[203Pb\\]Pb-PSV359 and \\[212Pb\\]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive.",[29,147,452,28,453,454,455,456],"Esophageal Cancer","Ovarian Cancer","Head and Neck Cancer","Sarcoma","Mesothelioma",[458,459,325,460,324,327,461,462,463,464,465,466,467],"Fibroblast Activation Protein","Solid tumor malignancy","Esophageal cancer","Head and neck cancer","Theronostic","Radiopharmaceutical","Radiotherapy","Alpha Particle","Pb-203","Pb-212","2026-06-03",{"date":470,"type":35},"2026-06-05",{"date":472,"type":35},"2025-04-28",{"date":474,"type":21},"2032-05-28",{"name":476,"class":42},"Perspective Therapeutics",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":160},"100630121","phase-2-ibi343-in-combination-therapy-for-advanced-malignant-solid-tumors-100630121","NCT07483554","IBI343 in Combination Therapy for Advanced Malignant Solid Tumors","A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of IBI343 in Combination Therapy for Patients With Advanced Malignant Solid Tumors.","Inclusion criteria:\n\n1. Signed written informed consent, willing and able to comply with the protocol-specified visits and related procedures.\n2. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n3. Age ≥ 18 years, no gender restrictions.\n4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Expected survival ≥ 12 weeks.\n6. Adequate bone marrow and organ function.\n7. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the end of treatment.\n8. Confirmed CLDN18.2 positive by central laboratory pathological tissue testing.\n\nExclusion criteria:\n\n1. Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.\n2. Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug.\n3. Received the last anti-tumor treatment within 4 weeks or 5 half-lives of the anti-tumor therapy (whichever is shorter) before the first dose of the investigational drug.\n4. Received therapeutic or palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.\n5. Underwent biliary stent placement within 7 days prior to the first dose of the investigational drug.\n6. Planning to receive other anti-tumor treatments during the period of treatment with the investigational drug.\n7. Received any live vaccine within 4 weeks prior to the first dose of the investigational drug or planning to receive any live vaccine during the study.\n8. Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has unhealed wounds, ulcers, or fractures; or plans to undergo major surgery during the study.\n9. Has not recovered from toxicity caused by previous treatment to grade 0 or 1 according to NCI CTCAE v5.0 prior to the first dose of the investigational drug.\n10. History of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of the investigational drug that was not cured by surgical treatment.\n11. Presence of pyloric obstruction and\u002For persistent recurrent vomiting.\n12. Post-procedure of stent implantation in the digestive tract or trachea.\n13. Symptomatic central nervous system metastasis.\n14. Bone metastasis with risk of paraplegia.\n15. Interstitial lung disease requiring steroid treatment, or history of interstitial lung disease, non-infectious pneumonia, severe impairment of pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having these diseases during the screening period.\n16. Presence of uncontrolled disease.\n17. History of other primary malignant tumors.\n18. Known history of immunodeficiency.\n19. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n20. Previous treatment with topoisomerase inhibitor-based antibody-drug conjugates.\n21. For subjects receiving drug treatment, a history of allergy to the corresponding drug or formulation.\n22. For subjects receiving drug treatment, contraindications for the corresponding drug.\n23. For subjects receiving drug treatment, a history of permanent discontinuation of the corresponding drug due to related adverse reactions.\n24. Pregnant or lactating female subjects.\n25. Other conditions deemed unsuitable for participation in this study by the investigator.",{"count":485,"type":21},389,[25],"A Phase II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of IBI343 in combination therapy for patients with advanced malignant solid tumors.To evaluate the efficacy and safety of IBI343 in combination therapy for patients with advanced malignant solid tumors.Enrollment of subjects with advanced gastric\u002Fgastroesophageal junction adenocarcinoma positive for CLDN18.2, and subjects with pancreatic ductal adenocarcinoma positive for CLDN18.2.",[489,490,29],"CLDN18.2 Positive","Gastric\u002FGastroesophageal Junction Adenocarcinoma",{"date":468,"type":35},{"date":493,"type":35},"2026-04-20",{"date":495,"type":21},"2028-03-31",{"name":497,"class":42},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":542,"leadSponsor":544,"locationsCount":160},"100639442","phase-1-a-first-in-human-trial-of-blu-924-sar449336-in-advanced-solid-tumors-harboring-kras-mutations-100639442","NCT07629960","A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations","A Phase 1\u002F2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of metastatic Kirsten rat sarcoma viral oncogene homolog (KRAS)-mutant pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) with evidence of a single KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA).\n2. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n4. Patients must have received all standard therapies for their cancer type in the metastatic setting, unless they are unable to receive such therapies due to clinical characteristics, comorbidities, or other medically justified reasons.\n\nExclusion Criteria:\n\n1. History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.\n2. Active brain metastases (participants with asymptomatic brain metastases may be eligible).\n3. Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.\n4. Active or uncontrolled systemic infection, such as tuberculosis, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":506,"type":21},265,[24,25],"A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 \u002F SAR449336, a pan-KRAS inhibitor, in participants with advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer harboring KRAS mutations.",[510,289,406,29],"Advanced Solid Tumor",[512,513,514,515,516,517,60,518,519,59,520,521,522,523,524,525,526,527,528,529,324,530,531,532,533,534,65,535,536,66,537,538],"Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","Metastatic Pancreatic Ductal Adenocarcinoma","KRAS G12A","KRAS G12C","KRAS G12S","KRAS G12V","KRAS-mutant","KRAS-positive","KRAS G13D","Pan-KRAS inhibitor","KRAS inhibitor","First-in-human","Solid tumor","Advanced cancer","Adult solid tumor","Metastatic solid tumor","Colon cancer","Rectal cancer","Metastatic colorectal cancer","Pancreatic cancer","Pancreatic ductal adenocarcinoma","Metastatic pancreatic cancer","Lung cancer","Precision oncology","Targeted therapy","2026-06-01",{"date":470,"type":35},{"date":32,"type":21},{"date":543,"type":21},"2031-07",{"name":545,"class":42},"Blueprint Medicines Corporation",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":568,"locationsCount":104},"100594835","phase-1-a-study-of-asp2138-given-before-surgery-then-chemotherapy-after-surgery-in-people-with-pancreatic-ductal-cancer-100594835","NCT07024615","A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer","A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression","Inclusion Criteria:\n\n* Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional multi-disciplinary review. Participant with localized pancreatic adenocarcinoma cannot have received any prior therapy.\n* Participant has confirmation of positive claudin (CLDN)18.2 test result by local laboratory prior to first dose of study intervention (ASP2138 dosing may be allowed after discussion with the medical monitor, if results are pending or a biopsy for CLDN18.2 testing is not clinically appropriate). Site should contact the sponsor to assess potential eligibility based on a local test result.\n* Participant has an available pretreatment tumor sample, if clinically appropriate and meets requirements.\n* Participant is able to undergo surgery and treatment with adjuvant chemotherapy per institutional standard of care.\n* Participant with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function of class 2B or better using the New York Heart Association Functional Classification.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy package insert \\[PI\\]\u002Fprescribing information, whichever is longer).\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (6 months) after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Female participant must not donate ova starting at first administration of neoadjuvant ASP2138, throughout the investigational period, and for 6 months after final ASP2138 administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must not donate sperm during the treatment period and for 6 months after ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Participant has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to the first dose of study intervention per investigator assessment.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has a corrected QT interval by Fridericia (QTcF) ≤ 470 msec.\n* Participant must meet all of the criteria based on laboratory tests within 7 days prior to the first dose of study intervention. Participant has adequate organ and marrow function. If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.\n* Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.\n* Participant has uncontrolled serious psychiatric illness or social situations that would preclude study compliance.\n* Participant has another malignancy for which treatment is required.\n* Participant has a history or complication of interstitial lung disease.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. NOTE: Applicable if participant is receiving fluoropyrimidine containing chemotherapy. Screening for DPD deficiency should be conducted per local requirements.\n* Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with full dose warfarin (coumadin) is not allowed.\n\n  * Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).\n* Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade ≥ 2 bleeding events in the month prior to treatment).\n* Participant has uncontrolled intercurrent illness or infection.\n* Participant is known to have human immunodeficiency virus (HIV) infection. However, participants with cluster of differentiation (CD) 4+ T cell counts ≥ 350 cells\u002FµL and no history of acquired immunodeficiency syndrome (AIDS) defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for HIV infection should be conducted per local requirements.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[hBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted per local requirements.\n\n  * For participant who is negative for hBsAg, but hepatitis B core (HBc) Ab positive, an HBV DNA test will be performed and if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has a known history of UGT1A1 gene polymorphism resulting in complete loss of function of the UGT1A1 gene product (for participants receiving irinotecan containing chemotherapy).\n* Participant has any pre-existing severe gastric conditions such as active gastritis or ulcer that could be exacerbated by treatment.\n* Participant has received any prior chemotherapy, radiation therapy, immunotherapy, or biologic (\"targeted\") therapy or investigational therapy for treatment of the participant's pancreatic tumor.\n* Participant has received a live vaccine within 30 days of planned start of study therapy. NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed.\n* Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.\n* Participant has had a major surgical procedure 28 days before start of study intervention and has not fully recovered.",{"count":7,"type":21},[24],"Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell \"tells\" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery.\n\nIn this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine.\n\nPeople will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.",[29],[558,559,560,561],"Claudin (CLDN) 18.2","ASP2138","Safety","Tolerability","2026-05-27",{"date":564,"type":35},"2026-05-28",{"date":566,"type":35},"2025-10-16",{"date":157,"type":21},{"name":569,"class":42},"Astellas Pharma Global Development, Inc.",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":22,"phases":579,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":160},"100562041","phase-1-a-study-to-determine-the-effect-of-ct3001-in-patients-with-advanced-solid-tumors-100562041","NCT06598007","A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors","A Phase 1\u002F2 First-In-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CT3001 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.\n* Aged ≥ 18 years (or adult age as per local regulations).\n* Histologically\u002Fcytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists. Note: In Phase 2b, only participants with advanced CRC who are eligible for re-engaging FOLFOX will be enrolled.\n* Has measurable disease per RECIST Version 1.1. that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.\n* Life expectancy ≥ 3 months, in the opinion of the PI or designee.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, liver, and kidney function as follows:\n\nBone marrow reserve:\n\n1. Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL without growth factor support in the 2 weeks prior to study entry.\n2. Hemoglobin ≥9.0 g\u002FdL without transfusion, growth factor support, or other supportive medication in the 2 weeks prior to study entry.\n3. Platelet count ≥ 75 × 10\\^9\u002FL without transfusion in 2 weeks prior to study entry.\n\nHepatic function:\n\n1. Serum TBIL \\\u003C 1.5 × ULN.\n2. AST and ALT \\\u003C 3 × ULN.\n\nRenal function:\n\nSerum creatinine clearance (CrCL) \\> 60 mL\u002Fmin, as per the Cockcroft-Gault Equation:\n\nCGGFR = \\[(140 - age in years) × weight in kg\\] \u002F (7.2 × serum creatinine in mg\u002FdL) (× 0.85 for females) (for urine protein \\\u003C 2+; if urine protein \\> 2+, 24-hour urinary protein quantity should be measured and must be \\\u003C 1.0 g).\n\n* Coagulation tests: international normalized ratio (INR) \\\u003C 1.5, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (Note: for those on oral anticoagulants, an INR in the range of 2 to 3 is acceptable).\n* Participants (both males and females) of childbearing potential should be willing to use a viable contraception method that is deemed effective by the PI or designee from Screening, during the study, and for at least 3 months following the last dose of IP. Postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential; postmenopausal status, if not known, is to be confirmed through testing of follicle-stimulating hormone (FSH) levels of ≥ 40 IU\u002FL. Male participants must be willing not to donate sperm until 3 months following the last IP administration.\n\nExclusion Criteria:\n\n* During Phase 1 Dose Escalation, receiving concurrent anticancer treatment (including chemotherapy, targeted drugs, radiotherapy \\[excluding the following small-area radiotherapy for bone metastasis\\], endocrine therapy, antitumor traditional Chinese Medicine), except during Phase 2b, Standard Care Chemotherapy (FOLFOX-based regimen) for advanced CRC patients is allowed.\n* Use of other IP within 5 half-lives of the product (if the IP is a small molecule) or anti-cancer investigational medical device within two weeks prior to the first administration of CT3001. Prior use of investigational monoclonal antibody IP can be permitted upon obtaining an approval from the Sponsor. Use of these investigational IP or devices are not permitted for the duration of treatment with CT3001.\n* Evidence of severe or uncontrolled systemic diseases, infection, or laboratory finding that in the view of the PI or designee makes it undesirable for the patient to participate in the trial.\n* Females who are pregnant or nursing, or any participant who is planning to become pregnant (self or partner) at any time during the study, including the Follow-up Period.\n* Has had major surgery or significant traumatic injury within 4 weeks of start of CT3001; participants have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or participant might require major surgery during the course of the study.\n* Has a prolonged QT interval corrected by Fredericia's formula (QTcF interval) of \\> 470 ms (determined by average of 3 readings on triplicate 12-lead ECG) or has a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long-QT syndrome) or current use of medications that prolong the QTcF interval.\n* Any psychiatric, psychological, familial or geographical condition that, in the judgment of the PI or designee, may interfere with the treatment and follow-up, affect compliance or place the participant at high risk of treatment-related complications will be excluded.\n* Blood donation or significant blood loss within 60 days prior to the first administration of CT3001.\n* History of severe allergic or anaphylactic reactions, or sensitivity to the CT3001 or its constituents.\n* Vaccination with a live vaccine within 4 weeks prior to the first administration of CT3001.\n* Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 5 half-lives of the product prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.\n* Use of any medications with a narrow therapeutics index that are sensitive substrates of and metabolized mainly through CYP2C8 within 5-half-lives of the products prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.\n* Use of any gastric acid reducing agents during the time period between 6 hours prior to and 2 hours after the administration of CT3001.\n* Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibodies (HIV-1\u002F-2) at Screening, unless the participant meets 1 of the following criteria:\n\n  1. Has chronic hepatitis B virus (HBV) infection or virologically suppressed (VS) HBV AND has been on suppressive antiviral therapy (unless it is a prohibited medication per exclusion criteria #12) for at least 4 weeks.\n  2. Has chronic HCV infection but has completed curative antiviral treatment (note: patients may be HCV antibody positive but must be HCV RNA negative to be eligible).\n\nPlease note: the eligibility of patients with HBV or HCV infection should be considered on a case-by-case basis by the PI in consultation with the independent Medical Monitor.\n\n* Anything that the PI considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.",{"count":578,"type":21},78,[24,25],"This is an FIH, multicenter, open-label, dose escalation and dose expansion\u002Fdose optimization study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2b. Phase 1 will be a standard 3+3 dose escalation and dose finding study in patients with advanced solid tumors for whom there is no available therapy (or patients are not candidates for such therapy) for the assessment of DLTs at up to 7 dose levels of CT3001. Phase 2b is a dose finding\u002Fdose optimization study of CT3001 in combination with SOC chemotherapy (FOLFOX) to evaluate the safety and preliminary efficacy of CT3001 in patients with advanced CRC who are eligible for re-engaging FOLFOX-based chemotherapy.",[59,28,29],{"date":583,"type":35},"2026-05-29",{"date":585,"type":35},"2024-09-20",{"date":587,"type":21},"2027-06-30",{"name":589,"class":42},"Crossignal Therapeutics, Inc.",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":22,"phases":598,"briefSummary":600,"conditions":601,"keywords":603,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":339},"100525527","early-phase-1-prospective-screening-for-pancreatic-ductal-adenocarcinoma-in-high-risk-individuals-100525527","NCT06122896","Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals","Inclusion Criteria:\n\nParticipants must meet any of the following:\n\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in STK11, and age ≥30 years.\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND\n\n  • Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic\u002Flikely pathogenic germline variant.\n* Individuals with pathogenic\u002Flikely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).\n* Individuals with familial pancreatic cancer including:\n\n  * Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant, OR\n  * Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant, OR\n  * Family history of exocrine pancreatic cancer in ≥3 first- and\u002For second-degree relatives from the same side of the family, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant.\n* Individuals who are undergoing clinically recommended pancreatic cancer surveillance.\n\nExclusion Criteria:\n\n* Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.\n* Individuals with any active metastatic cancer.\n* Individuals who are unable to give informed consent.\n* Individuals who are under the age of 18 (infants, children, teenagers).\n* Individuals unable to tolerate Magnetic Resonance Imaging\u002FMagnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.\n* Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.",{"count":597,"type":21},5000,[599],"EARLY_PHASE1","The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.",[196,29,65,198,602],"Pancreatic Neoplasm",[196,29,65,198,602],{"date":583,"type":35},{"date":606,"type":35},"2023-11-21",{"date":608,"type":21},"2041-10-31",{"name":610,"class":131},"Dana-Farber Cancer Institute",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":347,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":626,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":666},"100527382","phase-1-a-phase-1-dose-escalation-study-of-225ac-fpi-2068-in-adult-patients-with-advanced-solid-tumours-100527382","NCT06147037","A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours","A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours","Key Inclusion Criteria:\n\nHistologically and\u002For cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable.\n\nDisease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the participant refuses standard therapy.\n\nMeasurable disease as defined by RECIST Version 1.1\n\nECOG Performance status of 0 or 1\n\nAdequate organ function\n\nKey Exclusion Criteria:\n\nPrevious treatment with any systemic radiopharmaceutical\n\nPrior anti-cancer therapy unless adequate washout and recovery from toxicities\n\nContraindications to or inability to perform the imaging procedures required in this study\n\nRadiation therapy (RT) within 28 days prior to the first dose of \\[111In\\]-FPI-2107\n\nUncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month)\n\nPatients with known CNS metastatic disease unless treated and stable",{"count":619,"type":21},70,[24],"This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \\[225Ac\\]-FPI-2068, \\[111In\\]-FPI-2107, and FPI-2053 in metastatic and\u002For recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC).",[510,623,624,56,29,147,625],"Metastatic Colorectal Carcinoma","Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma",[627,628,629,630,631,632,633,67,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,66,65,652,653,654,655,656,657],"FPI-2068","FPI-2107","FPI-2053","Actinium-225","225Ac","Indium-111","111In","Targeted alpha therapy","TAT","Epidermal growth factor receptor","EGFR","Mesenchymal-epithelial transition factor","cMET","Bispecific antibody","Radioimmuno-SPECT agent","Radioimmuno-therapeutic agent","Monoclonal antibody","Bifunctional chelating agent","Radiopharmaceutical therapy","Alpha particle emitter","Directed bispecific monovalent antibody","bsAb","Bifunctional chelate","mCRC","HNSCC","GC","RCC","RLT","Radioligand Therapy","EGFRm","EGFRwt","2026-05-22",{"date":660,"type":35},"2026-05-26",{"date":662,"type":35},"2024-07-31",{"date":664,"type":21},"2028-05-12",{"name":77,"class":42},15,{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":674,"targetDuration":4,"studyType":22,"phases":676,"briefSummary":677,"conditions":678,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":690},"100567809","phase-1-ptm-101-in-pancreatic-ductal-adenocarcinoma-pdac-100567809","NCT06673017","PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)","A Phase Ib Dose Escalation\u002FDose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)","Inclusion Criteria:\n\n* Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology\u002Fcytology either at study-mandated laparoscopy or by prior biopsy\u002Fcytology\n* Indicated for laparoscopy\n* No prior therapy of any kind for PDAC\n* Acceptable laboratory values\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2\n* Ability to provide informed consent\n* No symptomatic pancreatitis\n* No other active medical issues which would confound interpretation of safety monitoring, efficacy results or prevent the subject from study participation\n* Subjects with childbearing potential must agree to use adequate contraception throughout study participation\n\nExclusion Criteria:\n\n* Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years. This criterion excludes a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancers, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to screening). Other potentially indolent cancers may be considered.\n* Contraindications or allergies to paclitaxel, PLGA (poly(lactic-co-glycolic ) acid), or contraindications to implantation of PTM-101 or chemotherapies in protocol (e.g., FOLFIRINOX, gemcitabine, nab-paclitaxel)\n* Known history of human immunodeficiency virus (HIV) or active viral hepatitis\n* Active ongoing infection or autoimmune disease which may preclude laparoscopy, placement of PTM-101, administration of chemotherapy or surgical resection of pancreatic tumor\n* Inability to comply with activities and therapeutic interventions as outlined in the schedule of events\n* Currently enrolled in another investigational drug or device trial\n* Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child\n* Any other medical or surgical conditions, including prior abdominal surgery, that would preclude safe laparoscopy or implantation in the opinion of the investigator",{"count":675,"type":21},26,[24],"This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation\u002Fdose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC).",[29,679,680,196],"Borderline Resectable Pancreatic Adenocarcinoma","Locally Advanced Pancreatic Adenocarcinoma","2026-05-19",{"date":683,"type":35},"2026-05-20",{"date":685,"type":35},"2025-04-14",{"date":687,"type":21},"2028-06",{"name":689,"class":42},"PanTher Therapeutics",6,{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":697,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":699,"phases":4,"briefSummary":700,"conditions":701,"keywords":710,"overallStatus":719,"whyStopped":4,"lastUpdateSubmitDate":720,"lastUpdatePostDateStruct":721,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":722,"locationsCount":4},"100599360","expanded-access-protocol-of-eli-002-102-in-subjects-with-krasnras-mutated-pancreatic-ductal-adenocarcinoma-100599360","NCT07083479","Expanded Access Protocol of ELI-002-102 in Subjects With KRAS\u002FNRAS Mutated Pancreatic Ductal Adenocarcinoma","Expanded Access Protocol for ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)\u002FNeuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC)","AMPLIFY-EAP","Inclusion Criteria:\n\n* Has at least 1 of the 7 KRAS\u002FNRAS mutated alleles (G12D, G12R, G12V, G12A, G12C, G12S, G13D)\n* The following must be met: (1) the patient has no alternative therapy to diagnose, monitor, or treat the disease or condition; (2) enrollment in a clinical trial is not possible; and (3) the potential benefit to the patient justifies the potential risks of treatment.\n* Screening CT scan negative for recurrent disease\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n\nExclusion Criteria:\n\n* Use of immunosuppressive drugs\n* Known brain metastases","EXPANDED_ACCESS","This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \\[Amph-CpG-7909\\] plus a mixture of lipid-conjugated peptide-based antigens \\[Amph-Peptides 7P\\]) as adjuvant treatment in patients with KRAS\u002FNRAS-mutated pancreatic ductal adenocarcinoma who are at high risk for relapse (ie, presence of isolated tumor cells in a patient whose primary tumor has been removed and is currently without clinical signs of disease). This protocol builds on the experience being obtained with ELI-002 7P (with Amph-Peptides G12D, G12R, G12V, G12A, G12C, G12S, G13D), which is being studied in protocol ELI-002-201.",[29,60,519,518,516,517,702,522,703,704,705,706,707,708,709],"KRAS G12R","NRAS G12D","NRAS G12V","NRAS G12S","NRAS G12A","NRAS G12C","NRAS G12R","NRAS G13D",[711,712,713,714,715,716,717,718],"Pancreatic ductal adenocarcinoma (PDAC)","Kirsten rat sarcoma (KRAS)","Neuroblastoma ras viral oncogene homolog (NRAS)","Adjuvant therapy","Immunotherapy","Vaccine therapy","Expanded access","Expandd access protocol (EAP)","AVAILABLE","2026-05-18",{"date":681,"type":35},{"name":723,"class":42},"Elicio Therapeutics",{"id":725,"slug":726,"hasResults":12,"nctId":727,"briefTitle":728,"officialTitle":729,"acronym":4,"eligibilityCriteria":730,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":731,"targetDuration":4,"studyType":22,"phases":733,"briefSummary":734,"conditions":735,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":720,"lastUpdatePostDateStruct":739,"startDateStruct":740,"completionDateStruct":742,"leadSponsor":744,"locationsCount":160},"100332465","phase-1-iexosomes-in-treating-participants-with-metastatic-pancreas-cancer-with-krasg12d-mutation-100332465","NCT03608631","iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation","Phase I Study of Mesenchymal Stromal Cells-Derived Exosomes With KrasG12D siRNA for Metastatic Pancreas Cancer Patients Harboring KrasG12D Mutation","Inclusion Criteria:\n\n* Patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma harboring KrasG12D mutation\n* Patients must have documented progression or stable disease on one or more lines of systemic therapy. If stable disease, patient must have completed at least 4 months of chemotherapy with cytotoxic therapy\n* KrasG12D mutation status will be informed from any previous routine molecular profiling (using commercial assays such as Foundation One, Caris, Oncomine or other) of tissue or blood. Additional KrasG12D mutation status may be confirmed using tissue biopsy or blood prior to enrolling into the trial\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0-1\n* Absolute neutrophil count (ANC) more or equal to 1,500 cells\u002Fmm3\n* Platelets more or equal to 100,000\u002Ful\n* Hemoglobin more than 9.0 g\u002FdL\n* Total bilirubin between 1 and 1.5 mg\u002FdL\n* AST (aspartate aminotransferase) and ALT (alanine transaminase) less than 2.5 x ULN (upper limit of normal)\n* Alkaline phosphatase less than 2.5 x ULN\n* Creatinine less than 1.5 gm\u002FdL\n* In patients with known Gilbert's syndrome, direct bilirubin less or equal to 1.5 x ULN will be used as organ function criteria, instead of total bilirubin\n* Negative serum pregnancy test in women with childbearing potential (WOCBP) defined as not post-menopausal for 12 months or no previous surgical sterilization, within one week prior to initiation of treatment. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy\n* A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. If the partner is pregnant or breastfeeding, the subject must use a condom\n* Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved\n\nExclusion Criteria:\n\n* Concurrent severe and\u002For uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection\n* Pregnancy (positive pregnancy test) or lactation\n* Known CNS (central nervous system) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging-MRI or computerized tomography-CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, linear accelerator \\[LINAC\\], or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded",{"count":732,"type":21},28,[24,25],"This phase I trial studies the best dose and side effects of mesenchymal stromal cells-derived exosomes with KrasG12D siRNA (iExosomes) in treating participants with pancreatic cancer with KrasG12D mutation that has spread to other places in the body. iExosomes may work better at treating pancreatic cancer.",[736,737,29,738],"KRAS NP_004976.2:p.G12D","Metastatic Pancreatic Adenocarcinoma","Stage IV Pancreatic Cancer AJCC v8",{"date":683,"type":35},{"date":741,"type":35},"2021-01-27",{"date":743,"type":21},"2027-04-30",{"name":745,"class":131},"M.D. Anderson Cancer Center"]