[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-ductal-adenocarcinoma-pdac\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-ductal-adenocarcinoma-pdac":34},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,59,0,25,[9,60,86,117,141,167,194,223,262,295,329,359,381,412,434,462,485,513,541,564,585,610,637,670,698],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100636166","phase-3-atebimetinib--gnp-as-a-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100636166",false,"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","ALL","18 Years",{"count":21,"type":22},510,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32,33,34,35],"Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Adenocarcinoma Metastatic","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma",[37,38,39,40,41,42,43,44,45,46],"mitogen-activated protein kinase (MAPK)","MAPK","MEK","metastatic cancer","gemcitabine","nab-paclitaxel","nab-p","atebimetinib","KRAS","pan-RAS","RECRUITING","2026-08-20",{"date":50,"type":51},"2026-08-21","ACTUAL",{"date":53,"type":51},"2026-06-05",{"date":55,"type":22},"2029-02",{"name":57,"class":58},"Immuneering Corporation","INDUSTRY",38,{"id":61,"slug":62,"hasResults":12,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100641682","phase-3-study-of-zoldonrasib--chemo-of-investigators-choice-vs-placebo--chemo-of-investigators-choice-as-first-line-treatment-in-metastatic-kras-g12d-mutated-pancreatic-adenocarcinoma--rasolute-305--100641682","NCT07621718","Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )","RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma","RASolute 305","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to screening.\n* Documented KRAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.\n* Prior systemic RAS-targeted therapy any time prior to randomization.\n* Presence of other known driver mutations with approved targeted therapies\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":69,"type":22},670,[25],"The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.",[28,29,30,31,34,33,35,73],"Pancreatic Adenosquamous Carcinoma",[28,30,32,75,45,76,29,33,73,35],"RAS","RAS Mutation","2026-08-19",{"date":50,"type":51},{"date":80,"type":51},"2026-05-22",{"date":82,"type":22},"2030-04-22",{"name":84,"class":58},"Revolution Medicines, Inc.",6,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100634619","artidis-nanomechanical-signature-profiling-of-pancreatic-cancer-specimens-100634619","NCT07542041","Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens","Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)","ANoPs","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to understand and willingness to sign a written informed consent form\n* Clinical indication for fine needle biopsy (FNB) of a suspicious pancreatic lesion accessible for biopsy\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study",{"count":95,"type":22},200,[97],"NA","The goal of this clinical study is to evaluate whether the NEO-Match® test, based on ARTIDIS nanomechanical profiling technology, can help predict treatment outcomes and improve clinical decision-making in patients with suspected pancreatic cancer undergoing biopsy.\n\nThe main questions this study aims to answer are:\n\n* Can the NEO-Match® test predict how patients respond to neoadjuvant (pre-surgical) treatment for pancreatic cancer?\n* How well does the NEO-Match® test detect malignant pancreatic lesions compared to standard histopathological assessment?\n\nThis is a prospective, single-arm study. Researchers will compare results from the NEO-Match® test with standard clinical outcomes, imaging findings, and pathology results to evaluate its predictive and diagnostic performance.\n\nParticipants will:\n\n* Undergo a standard-of-care pancreatic biopsy or surgical procedure\n* Provide an additional biopsy sample for research analysis using the ARTIDIS ART-1 device\n* Continue to receive standard treatment and care, which is not influenced by the study\n* Have clinical data, imaging results, and treatment outcomes collected\n* Be followed every 3 months for up to 2 years\n\nThe study does not involve experimental treatment or changes to standard medical care. The information collected may help improve future diagnosis, prognosis, and treatment selection for patients with pancreatic cancer.",[28,100,34,101],"Pancreatic Neoplasms","Pancreatic Lesions Located at the Body or the Tail",[103,104,105,106,32,28],"Atomic Force Microscopy","Neoadjuvant Therapy","Nanomechanical Profiling","NEO-Match","2026-08-15",{"date":109,"type":51},"2026-08-18",{"date":111,"type":51},"2026-04-17",{"date":113,"type":22},"2030-05",{"name":115,"class":58},"ARTIDIS AG",1,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":7},"100630728","phase-3-study-of-daraxonrasib-and-daraxonrasib--gnp-as-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100630728","NCT07491445","Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma","RASolute 303","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.\n* Documented RAS mutation status, either mutant or wild-type.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":126,"type":22},900,[25],"The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.",[28,29,30,31,34,33,35,73],[28,30,32,75,45,131,132,133,76,29,33,73,35],"NRAS","HRAS","RAS Wild-Type","2026-08-14",{"date":109,"type":51},{"date":137,"type":51},"2026-03-09",{"date":139,"type":22},"2029-03",{"name":84,"class":58},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100641650","phase-2-a-phase-2-study-of-vs-7375-in-patients-with-kras-g12d-mutated-pancreatic-cancer-100641650","NCT07644559","A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer","A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON\u002FOFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)","Inclusion Criteria:\n\n* Histopathology confirmed PDAC\n* Measurable disease per RECIST 1.1\n* Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)\n* ECOG PS=0 or 1\n\nAdequate organ function\n\nVS-7375 + cetuximab (2L PDAC) :\n\n-Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months\n\nVS-7375 + cetuximab (1L PDAC) :\n\n-Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease\n\nExclusion criteria:\n\n* Have any other documented co-existing common RAS mutation(s)\n* Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter\n* Major surgery within 4 weeks of first treatment dose\n* Radiation therapy (RT) within 1 week of first treatment dose; RT to brain or lung within 2 weeks of first treatment dose\n* History of drug-induced Interstitial Lung Disease\n* Receipt of prior direct RAS inhibitor\n* Untreated or symptomatic CNS metastasis\n* Receipt of strong CYP3A4 inhibitor\u002Finducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter\n* Receipt of PPI or H2 blocker within 5 days\n* Inability to swallow oral medication\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":149,"type":22},180,[151],"PHASE2","This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer",[34,154],"G12D Mutated KRAS",[156,45,30,32,28,100,75],"KRAS G12D mutation","2026-08-13",{"date":159,"type":51},"2026-08-17",{"date":161,"type":51},"2026-06-16",{"date":163,"type":22},"2028-12",{"name":165,"class":58},"Verastem, Inc.",24,{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":85},"100627609","phase-2-a-study-of-nuzefatide-pevedotin-bt5528-in-patients-with-metastatic-pancreatic-ductal-adenocarcinoma-pdac-100627609","NCT07450859","A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria\n\n* At least 18 years of age at the time of signature of the informed consent form (or at least 19 years where locally defined as minimum age of consent).\n* Measurable disease as defined by RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 12 weeks.\n* Histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).\n* Participants must have failed whose disease has progressed on or after only 1 prior line of therapy or on or after second line therapy with a KRAS inhibitor, with evidence of radiographic progression. Neoadjuvant or adjuvant systemic therapy may count as the first line if the participant progressed less than 6 months from the end of systemic therapy. Prior treatment with KRAS inhibitors in the first-line setting is permitted if there was no intervening treatment prior to enrollment.\n* Participants must have sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers.\n* Adequate organ function (hematologic, renal, and hepatic).\n* Negative pregnancy test for participants of childbearing potential (POCBP)\n* Must be willing and able to comply with the protocol and study procedures and agree to participate in the study by providing written informed consent.\n\nExclusion Criteria\n\n* Chemotherapy or radiotherapy within 14 days prior to the first dose of study treatment\n* Experimental treatments within 28 days or 5 half-lives, whichever is longer, of first dose of nuzefatide study treatment\n* Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer or prior treatment with any MMAE-containing agent\n* Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy\n* Prior toxicities must have resolved to Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0\n* Untreated central nervous system (CNS) metastases\n\nNote: Additional protocol defined Inclusion\u002FExclusion criteria apply",{"count":175,"type":22},39,[151],"This is a Phase 2 study for nuzefatide pevedotin (BT5528) in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and worsened after one previous treatment or two prior lines of treatment if treated with KRAS inhibitor.\n\nThe drug, nuzefatide pevedotin (nuzefatide), is designed to find a specific protein called EphA2.\n\nThe main aims of the study are to see how well the drug works against the tumor (efficacy), what side effects it may have (safety), and how the body processes it (pharmacokinetics). All participants in this study will receive nuzefatide, and both they and their doctors will know what is being administered (single-arm, open-label). The trial will take place at several different medical centers.",[34],[28,180,181,182,183,184,32,30,185],"BT5528","EphA2","Bicycle Drug Conjugate","MMAE","Metastatic","Nuzefatide Pevedotin","2026-08-11",{"date":157,"type":51},{"date":189,"type":51},"2026-03-05",{"date":191,"type":22},"2029-05",{"name":193,"class":58},"BicycleTx Limited",{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":220,"locationsCount":222},"100493513","phase-1-a-study-to-assess-safety-tolerability-and-imaging-characteristics-of-68gaga-dpi-4452-and-to-assess-safety-tolerability-and-efficacy-of-177lulu-dpi-4452-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100493513","NCT05706129","A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Non-Randomized Phase 1\u002F2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Written informed consent, dated and signed by the patient prior to any study-specific procedure.\n* Part B and C are not conducted in the United States of America.\n* Has histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:\n* Clear cell renal cell cancer (ccRCC) - participants must have received at least one line containing Tyrosine kinase inhibitor (TKI) treatment and at least one line containing immune checkpoint inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting.\n* Pancreatic ductal adenocarcinoma (PDAC) - participants must have received at least one line of platinum- and\u002For gemcitabine-based regimen.\n* Colorectal cancer (CRC) - participants must have received at least one line of FOLFIRINOX or FOLFOX\u002FFOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR).\n* Participants with CRC or PDAC: availability of fresh biopsy, OR an archival biopsy\u002Fsurgical specimen of the tumor (preferably, taken after last prior line of therapy).\n* For Part B and C only: Urothelial cancer (UC) patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab.\n* Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography \u002F magnetic resonance imaging (CT\u002FMRI)) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration.\n* Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nPart D:\n\nParticipants with imaging evidence of a single indeterminate renal mass (IDRM) of ≤ 7 cm in largest diameter (tumor stage cT1) on any conventional diagnostic imaging technique, suspicious for ccRCC and planned for total or partial nephrectomy, or interventional diagnostic (cystoscopy and retrograde pyelography or biopsy) within 90 days from planned \\[68Ga\\]Ga-DPI-4452 administration.\n\nPart E:\n\nRegardless of lines of treatment, participants with histologically or cytologically confirmed progressive, unresectable locally advanced or metastatic solid tumors of\n\n* UC, including MIBC\n* H\\&N cancer\n* TNBC\n* Squamous NSCLC\n* Any other indication with confirmed carbonic anhydrase IX (CA IX) expression excluding ccRCC, PDAC and CRC, upon Sponsor agreement.\n\nPresence of at least 1 non-irradiated tumor lesion detected at conventional imaging (CT\u002FMRI) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration (for scans dated more than 4 weeks prior to D1, the Sponsor should be contacted to assess conventional imaging suitability)\n\nExclusion Criteria:\n\n* Any major surgery within 12 weeks before enrolment.\n* Inability to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan.\n\nPart A:\n\n* Has known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and\u002For stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\]).\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Previous Carbonic anhydrase (CA) IX-targeting treatment.\n* Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator.\n\nPart B and Part C:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, active clinically significant cardiac disease, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, or stable Grade 2 sensory neuropathy, according to NCI-CTCAE).\n* Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment for non-oncological indication within 3 months prior to the \\[177Lu\\]Lu-DPI-4452 infusion; any previous CA IX-targeting treatment for any oncological indication.\n* Participants who received any systemic antineoplastic therapy for the underlying disease and\u002For other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).\n* Inflammatory bowel disease (e.g Crohn's disease, ulcerative colitis, etc).\n\nPart D:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Any previous CA IX-targeting treatment within 3 months prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n* Ongoing treatment with sulfonamides and\u002For coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 half-lives, whichever is longer) prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n\nPart E:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment within 3 months prior to \\[68Ga\\]Ga-DPI-4452 injection.\n* EBRT to more than 25% of the bone marrow, as judged by the Investigator.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n\nNote: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.",{"count":202,"type":22},270,[204,151],"PHASE1","The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \\[68Ga\\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \\[maximum tolerated dose (MTD) or lower dose\\] for \\[177Lu\\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \\[177Lu\\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \\[68Ga\\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \\[68Ga\\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.",[207,34,208,209,210,211,212,213,214],"Clear Cell Renal Cell Cancer (ccRCC)","Colorectal Cancer (CRC)","Urothelial Carcinoma (UC)","Indeterminate Renal Mass (IDRM)","Muscle Invasive Bladder Cancer (MIBC)","Head and Neck Cancer (H&N)","Triple Negative Breast Cancer (TNBC)","Squamous Non-Small Cell Lung Cancer (NSCLC)","2026-08-07",{"date":186,"type":51},{"date":218,"type":51},"2023-03-14",{"date":139,"type":22},{"name":221,"class":58},"Lumara Bio Oncologics GmbH",10,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":258,"leadSponsor":260,"locationsCount":116},"100649317","phase-1-study-of-203pb-rmx-vh-pib-dosimetry-and-biodistribution-in-patients-with-glioblastoma-multiform-gbm-and-pancreatic-ductal-adenocarcinoma-pdac-100649317","NCT07733674","Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Glioblastoma Multiform (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC)","Dosimetry and Bio-distribution of 203Pb-RMX-VH-PIB in Newly Diagnosed or Recurrent Patients With Solid Tumors: A Phase I Exploratory Study","RMX-VH","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Subjects aged ≥18 years.\n3. Karnofsky status ≥60.\n4. Negative urine pregnancy test in women of childbearing potential.\n5. Histologically confirmed and \u002For highly suspicious GBM (Adult type Astrocytoma grade IV both IDH-Mutant and IDH-Wild Type) including primary, recurrent or stable enhancing residual or primary, recurrent or stable enhancing residual PDAC.\n\n   a. GBM group i. Contrast enhanced Brain MRI image with results compatible with GBM within the 2 weeks of dosing day.\n\n   ii. Tumor size of ≥ 1.0 cm in any dimension by MRI. iii. No antiangiogenic therapy within 4 weeks of the day of dosing. iv. No chemotherapy within 2 weeks of the day of dosing. v. Subjects receiving corticosteroids must be on a stable or decreasing dose regimen prior to enrollment b. PDAC group i. No chemotherapy within 2 weeks of the day of dosing ii. Tumor size of ≥ 1.0 cm in any dimension by MRI or CT\n6. Recent blood test results (within 4 weeks pre-dose) as follows:\n\n   1. WBC: ≥ 2 x 109\u002FL\n   2. Haemoglobin: ≥ 8 g\u002FdL\n   3. Platelets: ≥75 x 109\u002FL\n   4. ALT, AST, AP ≤ 5 times ULN\n   5. Bilirubin: ≤ 2 times ULN\n   6. Creatinine clearance ≥ 60 mL\u002Fmin, calculated by the Cockcroft-Gault equation\n\nExclusion Criteria:\n\n1. Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB.\n2. Inability to undergo MRI or CT\u002FSPECT\u002FCT scans\n3. Current somatic or psychiatric disease\u002Fcondition that may interfere with consent or the objectives and assessments of the study.\n4. Pregnancy or plans to conceive during the course of study participation.\n5. In GBM groups participants requiring MRI: History of hypersensitivity or contraindication to gadolinium-based contrast agents, including prior allergic or anaphylactoid reactions to gadolinium contrast media, or any condition (e.g., severe renal impairment, acute kidney injury) that, in the investigator's judgment, increases the risk associated with gadolinium administration.\n6. In PDAC groups participants requiring CT scans: Any contraindications to iodinated contrast agents include a history of severe hypersensitivity or allergic reaction to iodinated contrast media, significant renal impairment (e.g., eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² or acute kidney injury), uncontrolled hyperthyroidism or other thyroid disorders that may worsen with iodine exposure, prior contrast-induced nephropathy, pregnancy, and any unstable medical condition such as severe heart failure or hemodynamic instability that, in the investigator's judgment, increases the risk of contrast administration.\n7. Male and female participants of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of the study.\n8. Women who are breastfeeding\n9. Participants who are currently receiving treatment with statins (HMG-CoA reductase inhibitors), including but not limited to atorvastatin, rosuvastatin, pitavastatin, simvastatin, lovastatin, pravastatin, or fluvastatin, are excluded unless the medication has been discontinued for at least four (4) drug half-lives prior to administration of the investigational product",{"count":232,"type":22},20,[204],"The goal of this Phase I clinical trial is to evaluate how the imaging drug 203Pb- RMX-VH-PIB distributes in the body and how much radiation different organs receive in patients with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC).\n\nThe main questions it aims to answer are:\n\nHow does 203Pb-RMX-VH-PIB spread in the body (biodistribution)? What is the radiation dose delivered to organs (dosimetry)?\n\nParticipants will:\n\nReceive a single intravenous (IV) injection of 203Pb-RMX-VH-PIB. Undergo multiple single-photon emission computed tomography\u002Fcomputed tomography (SPECT\u002FCT) imaging scans.\n\nHave blood, urine, vital signs, and electrocardiogram (ECG) monitored for safety.\n\nBe followed for any side effects for up to 30 days.",[236,34],"Glioblastoma Multiforme (GBM)",[236,34,238,239,240,241,28,242,243,244,245,246,247,248,249,250,251,252,253,254],"203Pb-RMX-VH-PIB","SPECT\u002FCT Imaging","Radiopharmaceutical","Brain Tumor","RMX-VH-02","lead-203","radiolabeled peptide","investigational radiopharmaceutical","diagnostic radiopharmaceutical","tumor-targeted radiopharmaceutical","malignant glioma","high-grade glioma","malignant brain tumor","astrocytoma","IDH-wildtype glioblastoma","brain tumor targeting","Astrocytoma grad IV","2026-08-04",{"date":215,"type":51},{"date":107,"type":22},{"date":259,"type":22},"2027-06-30",{"name":261,"class":58},"Radiomedix, Inc.",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":281,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":294},"100610406","phase-1-a-study-of-stro-004-in-adults-with-refractoryrecurrent-metastatic-cancer-100610406","NCT07227168","A Study of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Cancer","A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal\u002FGastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma\n* Age 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies\n* Availability of tumor tissue\n* Measurable disease per RECIST 1.1\n* Adequate organ function\n* Participants receiving anticoagulants must be on a stable dose\n\nExclusion Criteria:\n\n* Eye disorders\n* Untreated brain metastases\n* Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition\n* Previous solid organ or bone marrow transplantation\n* Concurrent participation in another therapeutic treatment trial",{"count":95,"type":22},[204],"This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts:\n\n* Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF).\n* Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity.\n* Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.",[273,274,275,276,277,34,278,279,280],"Head and Neck Squamous Cell Carcinoma HNSCC","Non-Small Cell Lung Cancer NSCLC","Esophageal Cancer","Gastric Cancer","Colorectal Cancer","Cervical Cancer","Endometrial Cancer","Urothelial Cancer",[282,283,284,285],"Tissue Factor (TF)","STRO-004","Antibody Drug Conjugate","ADC",{"date":287,"type":51},"2026-08-06",{"date":289,"type":51},"2025-11-07",{"date":291,"type":22},"2028-04",{"name":293,"class":58},"Sutro Biopharma, Inc.",9,{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":303,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":318,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":116},"100643204","ctdna-monitoring-after-pancreatic-cancer-surgery-k-4care-lite-study-100643204","NCT07597252","ctDNA Monitoring After Pancreatic Cancer Surgery (K-4CARE Lite Study)","A Prospective Observational Study of Circulating Tumor DNA Dynamic Monitoring Using K-4CARE Lite Platform After Curative Resection of Pancreatic Cancer","K4CARE-PDAC","Inclusion Criteria:\n\n* Age 20 years or older\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), including its histological subtypes\n* Has undergone curative-intent resection (R0 or R1, defined as margin \\\u003C1 mm), via pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy\n* Post-operative pathologic stage at least pT1, with N0 or N1 or higher\n* Computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks before enrollment confirming no evidence of residual tumor and no distant metastasis\n* Intent to receive adjuvant chemotherapy\n* Sufficient surgical FFPE tumor tissue available for genomic sequencing\n* Able to understand and provide signed informed consent\n* Patients with or without prior neoadjuvant chemotherapy are both eligible\n\nExclusion Criteria:\n\n* Post-operative pathologic stage IV (distant metastasis), or R2 resection\n* Concurrent active primary malignancy (except cured non-melanoma skin cancer or carcinoma in situ within the past 5 years)\n* Severe post-operative complications precluding initiation of adjuvant chemotherapy within 12 weeks\n* Receipt of post-operative radiation therapy\n* Known hematologic disease or myeloproliferative disorder that may significantly affect ctDNA assay accuracy\n* Pregnant or breastfeeding women\n* Unable to comply with the protocol-specified blood draw schedule","20 Years",{"count":305,"type":22},30,"OBSERVATIONAL","Pancreatic ductal adenocarcinoma (PDAC) carries one of the worst prognoses among solid tumors. Even after curative-intent resection, 70-80% of patients recur within two years. Current post-operative surveillance relies on computed tomography (CT) imaging and the serum tumor marker CA 19-9, but both have limited sensitivity for detecting microscopic residual disease.\n\nThis single-center, prospective observational study evaluates the use of the K-4CARE Lite platform-a tumor-informed plus tumor-agnostic circulating tumor DNA (ctDNA) assay with a limit of detection of 0.005%-for dynamic monitoring of minimal residual disease (MRD) in patients with resected PDAC.\n\nThirty adult patients who have undergone R0 or R1 (margin \\\u003C1 mm) resection at Linkou Chang Gung Memorial Hospital will be enrolled over 24 months. Each participant will provide one baseline tumor tissue sample (formalin-fixed paraffin-embedded) and three serial blood samples at three pre-specified study timepoints: Timepoint 1 (Week 4 to Week 10 after surgery, before adjuvant chemotherapy); Timepoint 2 (12 weeks after Timepoint 1, approximately 3 months into adjuvant chemotherapy); and Timepoint 3 (at completion of adjuvant chemotherapy, approximately Month 6 after surgery). A fourth long-term follow-up phase (Timepoint 4) collects results from patient-funded ctDNA testing performed as part of routine care.\n\nThe primary outcome is the cumulative MRD detection rate across the three pre-specified post-surgical timepoints (Timepoint 1, Timepoint 2, and Timepoint 3). Secondary outcomes include the association between ctDNA status and disease-free survival (DFS) and overall survival (OS), molecular clearance rate at Timepoint 3, lead time of molecular relapse over imaging, and platform performance. ctDNA results are reported back to the treating physician for reference but do not mandate treatment changes-all clinical decisions remain at the physician's discretion per standard guidelines.\n\nThis study aims to generate the prospective evidence base needed to design future ctDNA-guided interventional trials in pancreatic cancer.",[34,309],"NGS Monitor MRD",[311,312,313,314,315,316,317],"pancreatic cancer","circulating tumor DNA","minimal residual disease","tumor-informed sequencing","adjuvant chemotherapy","liquid biopsy","K-4CARE Lite","NOT_YET_RECRUITING","2026-07-31",{"date":321,"type":51},"2026-08-03",{"date":323,"type":22},"2026-09-01",{"date":325,"type":22},"2029-04-30",{"name":327,"class":328},"Chang Gung Memorial Hospital","OTHER",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":166},"100612578","phase-2-a-clinical-trial-testing-the-safety-of-pumitamig-an-investigational-drug-and-how-well-it-works-when-combined-with-chemotherapy-for-people-who-have-not-been-treated-yet-for-pancreatic-cancer-100612578","NCT07255404","A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer","A Phase II, Multi-site, Randomized, Open-label, Trial of Pumitamig in Combination With Chemotherapy in Patients With Metastatic Pancreatic Cancer","Key Inclusion Criteria:\n\n* Have a histologically or cytologically confirmed metastatic PDAC. A tissue sample, archival or fresh, must be provided during the screening period, unless biopsy is not feasible due to safety concerns.\n* Have not received prior systemic therapy for unresectable metastatic PDAC. For participants who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant\u002Fneoadjuvant chemotherapy for curative-intent, the interval should be at least 6 months from the end of the last treatment to relapse.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures) are not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system \\[CNS\\] metastasis should not be considered as a measurable lesion).\n* Agree to discontinue strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A), CYP2C8, glucuronosyltransferase 1 family, polypeptide A cluster 1A (UGT1A1) at least 2 weeks prior to starting study treatment, and change to other treatment regimens at screening if such drugs are used.\n\nKey Exclusion Criteria:\n\n* Have received any of the following therapies or drugs before study enrollment:\n\n  * Have received prior systemic anticancer therapy for unresectable metastasis disease. Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment\n  * Any immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting study treatment.\n  * PD(L)-1\u002FVEGF bispecific antibody, including monotherapy with either category or combinations thereof.\n  * Systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 14 days before starting study treatment. Exception: Excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergies) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).\n  * Vaccinations with live attenuated vaccine(s) within 4 weeks before starting study treatment.\n  * Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before initiation of study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study.\n* Have undergone major organ surgery (core needle biopsies are allowed \\>7 days before starting study treatment), open biopsy, significant trauma, or invasive dental procedures (such as dental implants) within 28 days before starting study treatment, or a planned\u002Fanticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and\u002For complications from the treatment before starting study treatment.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* Have spinal cord compression or CNS metastases that are untreated and symptomatic or require treatment with corticosteroids or anticonvulsants for associated-symptom control. Exception: Treated brain metastases which are no longer symptomatic and for which no corticosteroid or anticonvulsant treatment is needed (the participant must have recovered from the acute toxic effect of radiotherapy).\n* Have active autoimmune disease or history of autoimmune diseases with anticipated relapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for those with clinically stable autoimmune thyroid disease or type 1 diabetes mellitus.\n* Have had other malignant tumors within 5 years before starting study treatment. Exception: Those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer).\n* Have heart conditions as specified in the protocol within 6 months before starting study treatment.\n* History of myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months before starting study treatment.\n* History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (e.g., inferior vena cava filter placed) and\u002For adequately anticoagulated on a prophylactic dose.\n* Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fractures. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders as specified in the protocol.\n* Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Those with indwelling catheters (e.g., PleurX) are allowed.\n* Participants with a history of serious Grade 3 or higher immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy. Participants with a history of Grade 3 or higher irAEs that did not lead to treatment discontinuation of a prior immunotherapy may be enrolled at the investigator's discretion.\n* Have adverse events (AEs) from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain AEs pose no safety risk to participants, such as hair loss, or stable hypothyroidism under hormone replacement therapy).\n* Have gastrointestinal symptoms or conditions as specified in the protocol.\n* Have a known or suspected hypersensitivity to the study treatments including any active ingredient or excipients thereof.\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n* Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease. Those with a history of pulmonary fibrosis or with currently diagnosed severe lung diseases such as interstitial pneumonia, pneumoconiosis, chemical pneumonitis, or any other condition resulting in significant impairment in lung function. Exception: Asymptomatic interstitial changes caused by previous radiotherapy, chemotherapy, or other factors such as smoking are allowed.\n* Have active infection (e.g., bacterial or fungal infections or tuberculosis) requiring systemic treatment or any uncontrolled infection within 14 days prior to the first dose of study treatment.\n* Have active syphilis. Participants with inactive previous infection could be eligible: Infection with a positive non-specific antibody test for syphilis (e.g., TRUST \\[Toluidine Red Unheated Serum Test\\], Rapid Plasma Reagin \\[RPR\\], TP-PA \\[Treponema pallidum Particle Agglutination\\]) or have a positive syphilis-specific antibody test (e.g., TPPA) (a positive \"syphilis-specific antibody test\" but a negative \"non-specific antibody test for syphilis\" for more than 1 year) infection.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":337,"type":22},105,[151],"This study will enroll adults with confirmed metastatic pancreatic ductal adenocarcinoma (PDAC, systemic PDAC treatment naïve), Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, and adequate organ function. Participants will receive pumitamig (also known as BNT327, BMS-986545, or PM8002) in combination with chemotherapy.",[34],[30,342,343,344,345,346,347,348,349],"Bispecific antibody","Metastatic pancreatic cancer","Immunotherapy","Immunotherapy in combination with chemotherapy","Programmed death-ligand 1 (PD-L1)","Vascular endothelial growth factor(-A) (VEGF-A)","Pumitamig","BNT327","2026-07-27",{"date":352,"type":51},"2026-07-28",{"date":354,"type":51},"2025-12-04",{"date":356,"type":22},"2028-08",{"name":358,"class":58},"BioNTech SE",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":371,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":116},"100438540","phase-2-eus-rfa-pancardinal-1-trial-100438540","NCT04990609","EUS-RFA PANCARDINAL-1 Trial","A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer","Inclusion Criteria:\n\n* Diagnosed and histologically-confirmed PDAC by biopsy\n* Permanent street address\n* Consent to study participation\n* Axial CT scan consistent with PDAC\n* No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n\nExclusion Criteria:\n\n* Male or female patients \\\u003C 18 years of age\n* No permanent street address or telephone number\n* Pregnant patients\n* Inmates or prisoners\n* Unable to provide informed consent",{"count":367,"type":22},60,[151],"The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.",[34],[372],"Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)",{"date":374,"type":51},"2026-07-29",{"date":376,"type":51},"2021-08-13",{"date":378,"type":22},"2028-05-30",{"name":380,"class":328},"The University of Texas Health Science Center, Houston",{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":390,"conditions":391,"keywords":398,"overallStatus":318,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":85},"100647926","breath-research-narrow-validation-for-gastrointestinal-cancer-detection-100647926","NCT07714538","Breath Research Narrow Validation for Gastrointestinal Cancer Detection","BRAVE","Inclusion Criteria:\n\nAdult participants ≥ 18 years old who meet at least one of the following criteria\n\nColorectal arm:\n\n1. Cancer: Histologically-confirmed CRC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign colonoscopy findings\n\nPancreatic arm:\n\n1. Cancer: Histologically-confirmed PDAC\\*\n2. Control: Non-specific abdominal symptoms with a radiologically-normal pancreas\n\nOesophagogastric arm:\n\n1. Cancer: Histologically-confirmed OGC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings\n\nOesophageal squamous arm:\n\n1. Cancer: Histologically-confirmed OSCC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings\n\nLiver arm:\n\n1. Cancer: Histologically- or radiologically-confirmed HCC or CCC\\*\n2. Control: Non-specific abdominal symptoms with a radiologically-normal liver\n\n   * Patients with suspected cancer (e.g. based on imaging) but who do not have histological confirmation prior to participating in the study may still be recruited and followed up to determine whether or not a diagnosis of cancer was subsequently confirmed.\n\nExclusion Criteria:\n\n* Patients who have already received chemotherapy, radiotherapy or surgery for their cancer\n* History of another cancer (other than non-melanoma skin cancers) within three years\n* Participants with co-morbidities preventing breath collection\n* Unable or unwilling to provide informed consent\n* (For Oesophagogastric arm only): Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid\n* (For Colorectal arm only): Participants receiving bowel prep in the previous 7 days",{"count":389,"type":22},1000,"The investigators of this study are developing a simple breath test to help detect gastrointestinal (gut) cancers earlier, including cancers of the oesophagus (food pipe), stomach, pancreas, liver and bowel. These cancers often cause non-specific symptoms that are similar to benign conditions, making early diagnosis difficult. Delays between the onset of symptoms and referral for a diagnostic test such as an endoscopy or a scan, can allow the cancer to progress.\n\nThe breath test detects small molecules called volatile organic compounds (VOCs) that are released in exhaled breath. Some of these VOCs are strongly associated with these cancers and may help identify high-risk patients who require urgent investigation.\n\nIn practice, patients who come to their GP with concerning symptoms will be offered the breath test. If the test is positive, patients can be referred promptly for a diagnostic test, while those with a negative result can be reassured and offered re-testing if symptoms persist. Earlier diagnosis could improve access to curative treatment while reducing unnecessary invasive investigations.\n\nPrevious studies have identified a panel of VOCs that appear to distinguish patients with gastrointestinal cancers from those without cancer. This study aims to confirm these findings in a new group of participants to determine whether the same biomarkers can be reliably identified.\n\nParticipants will provide a breath sample, usually before a hospital procedure they are already scheduled to undergo, and complete a short questionnaire about their medical history and medications. Some participants will also be asked to drink a nutritional supplement before providing a second breath sample. The results will help determine whether the breath test is reliable enough for further clinical evaluation",[392,393,394,34,395,396,397],"Oesophageal Squamous Cell Carcinoma","Oesophageal Adenocarcinoma","Gastric Adenocarcinoma","Cholangiocarcinoma","Hepatocellular Carcinoma (HCC)","Colorectal Adenocarcinoma",[399,400,401,276,277,402,28],"Early Detection","Volatile Organic Compunds","Oesophageal Cancer","Liver Cancer","2026-07-21",{"date":405,"type":51},"2026-07-23",{"date":407,"type":22},"2026-07-20",{"date":409,"type":22},"2028-08-02",{"name":411,"class":328},"Imperial College London",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":421,"conditions":422,"keywords":423,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":433},"100640724","panuri-performance-study-100640724","NCT07587866","Panuri Performance Study","Evaluation of the Performance of Panuri - Test for Detection of Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Arm 1 (Target Arm):\n\n  * Adults 18 years and older\n  * Presenting with symptoms supporting a clinical suspicion for pancreatic cancer by the healthcare provider, including but not limited to jaundice, abdominal or back pain, fatty stools, unexplained weight loss, loss of appetite, chronic fatigue, nausea, vomiting, indigestion, bloating, gas, diarrhea, constipation, itching, dark urine, fever, and swelling of the legs.\n* Arm 2 (Enriched Arm):\n\n  * Adults 18 years and older\n  * Scheduled for a procedure involving pancreatic histopathological assessment due to suspicion of pancreatic cancer.\n\nExclusion Criteria:\n\n* For subjects in the enriched arm, imaging results are highly suspicious for non-PDAC pancreatic cancer.\n* Patients enrolled in a pancreatic cancer screening program.\n* Prior diagnosis of pancreas malignancy, including pathological diagnoses and suspicion of pancreatic cancer based on clinical, histopathological or radiological results. Exceptions include: pancreatic intraepithelial neoplasia (PanIN), intraductal papillary mucinous neoplasms (IPMN), mucinous cystadenoma of the pancreas (MCN), serous cystadenomas (SCN) or other benign pancreatic lesions and cystic lesions without features suggestive of malignancy.\n* History of pancreatic resection\n* Presenting with concurrent symptoms or suspicion of urinary tract infection Diagnosis of any urinary tract infection within the last 30 days, except for cases that have been resolved with antibiotics discontinued at least 14 days prior to enrollment\n* Diagnosed with stage 3b to 5 chronic kidney diseases (CDK3b-CDK5), acute kidney disease in last 3 months, nephrotic syndrome in the last 6 months, or other kidney diseases associated with proteinuria\n* Diagnosed with any conditions that increase bilirubin levels within the last 6 months\n* Self-reported or documented elevated blood bilirubin levels within the past 3 months, defined as exceeding 1.5 times the upper limit of normal specific to the test laboratory\n* Diagnosis of any cancer within the past 5 years\n* Chemotherapy or anti-neoplastic therapy within the last 5 years\n* Any medical or psychological conditions that preclude compliance with study procedures.\n* Patients without any clinical signs or symptoms of pancreatic cancer\n* Inability to provide written informed consent.\n* Pregnant or breastfeeding women\n* Current participation in another drug or device study or planned participation prior to completion of sample collection procedures (i.e., approximately 1.5 months)",{"count":420,"type":22},1100,"The main purpose of the study is to assess the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma (PDAC) the most common type of pancreatic cancer that accounts for approximately 90% of all pancreatic cancer cases.\n\nThe study aims to characterize the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma in patients with symptoms supporting a clinical suspicion of pancreatic cancer The Panuri test is intended for professional laboratory use for diagnostic purposes.",[34],[424,425],"in vitro diagnostic assay","clinical performance study",{"date":405,"type":51},{"date":428,"type":51},"2026-06-10",{"date":430,"type":22},"2028-01",{"name":432,"class":58},"Urteste S.A",32,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":441,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":450,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":85},"100645452","phase-2-68gabed003-pet-imaging-of-fibroblast-activation-protein-in-selected-oncology-indications-100645452","NCT07702292","[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","A Phase 2 Study of [68Ga]BED003 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. Women of childbearing potential (WOCBP) must have a negative serum test at screening and a negative urine pregnancy test at the PET\u002FCT imaging visit (Visit 2) prior to \\[68Ga\\]BED003 administration.\n\n   Note: If combining screening (Visit 1) and the PET\u002FCT imaging visit (Visit 2) into a single visit, a serum pregnancy test must be used to exclude pregnancy.\n5. WOCBP, and men who are sexually active with WOCBP, must agree to use a highly-effective method(s) of contraception from the PET\u002FCT imaging visit (Day 1\u002FVisit 2) to the safety follow-up telephone call (Day 3\u002FVisit 3).\n6. 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).\n\n   Note: Invasive breast cancer with mixed ductal\u002Flobular histology is permitted.\n7. Conventional imaging performed within 8 weeks of screening (Visit 1) and no later than 24 hours before \\[68Ga\\]BED003 administration and available for sending to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.\n8. 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. Cytology of the primary lesion is acceptable for participants with PDAC who are not surgical candidates.\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.\n   3. Suspected recurrence after definitive therapy.\n\nExclusion Criteria:\n\n1. Participants administered any radioisotope within 5 physical half-lives prior to \\[68Ga\\]BED003 administration.\n2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to \\[68Ga\\]BED003 administration.\n3. Participants who have recently received any other contrast agent (\\\u003C 24 hours for IV agents and \\\u003C 5 days for oral agents) before the day of \\[68Ga\\]BED003 administration.\n4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.\n5. Known hypersensitivity to \\[68Ga\\]BED003 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, including, but not limited to, the following:\n\n   1. Any other primary cancers that could confound the interpretation of the study results.\n   2. Major surgery (such as laparoscopy\u002Flaparotomy\u002Fthoracotomy) over the 3 months preceding screening that could confound the interpretation of the study results.\n   3. Serious, non-healing wound, ulcer, or bone fracture.\n   4. Active hepatitis.\n   5. Significant cardiac disorders including recent (in last 3 months) myocardial infarction or clinically significant electrocardiogram (ECG) findings.\n7. Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgement, excluding disorders directly related to the index cancer (e.g. tumour-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 judgement.\n10. Significant renal impairment, defined as an estimated glomerular filtration rate (as determined by the Modification of Diet in Renal Disease formula) below 45 mL\u002Fmin\u002F1.73m2 or a serum creatinine \\> 1.5 × the upper limit of normal.\n11. Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from from the PET\u002FCT imaging visit (Day 1\u002FVisit 2) to the safety follow-up telephone call (Day 3\u002FVisit 3).","79 Years",{"count":443,"type":22},65,[151],"This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of \\[68Ga\\]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).",[277,447,448,34,449],"Epithelial Ovarian Cancer","Gastric Cancer (GC)","Invasive Lobular Breast Carcinoma",[451,452],"Positron emission tomography","Fibroblast activation protein","2026-07-14",{"date":455,"type":51},"2026-07-15",{"date":457,"type":51},"2026-06-30",{"date":459,"type":22},"2028-02",{"name":461,"class":58},"Blue Earth Diagnostics",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":318,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":481,"leadSponsor":483,"locationsCount":4},"100647517","predictive-biomarkers-for-early-diagnosis-of-pancreatic-ductal-adenocarcinoma-pdac-100647517","NCT07709052","Predictive Biomarkers for Early Diagnosis of Pancreatic Ductal Adenocarcinoma (PDAC)","B-PDAC","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients undergoing pancreatic surgical resection for suspected pancreatic neoplasm.\n* Histopathologic diagnosis of intraductal papillary mucinous neoplasm (IPMN), pancreatic intraepithelial neoplasia (PanIN), or pancreatic ductal adenocarcinoma (PDAC).\n* Availability of residual tumor tissue from the surgical procedure not required for diagnostic purposes.\n* Signed written informed consent for the use of biological samples for research purposes\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Surgical procedure performed for neoplasms other than IPMN, PanIN, or PDAC.\n* Absence of written informed consent.",{"count":149,"type":22},"Pancreatic ductal adenocarcinoma (PDAC) is one of the cancers with the poorest prognosis and is often diagnosed at an advanced stage, resulting in very low 5-year survival rates. Many PDACs arise from non-invasive precursor lesions that develop over years, including pancreatic intraepithelial neoplasia (PanIN) and intraductal papillary mucinous neoplasms (IPMN). Only a minority of pancreatic cystic lesions progress to invasive carcinoma, and current clinical and radiologic criteria have limited accuracy in predicting which patients are at high risk. This observational translational study will enroll adult patients undergoing pancreatic surgical resection for suspected pancreatic neoplasm (IPMN, PanIN, or PDAC) at IRCCS \"Saverio de Bellis\". Residual tumor tissue not required for diagnostic purposes, and when available adjacent non-neoplastic tissue, will be collected, coded, and pseudonymized for molecular analyses. Tumor cells will be used to generate three-dimensional cultures (tumorspheres and organoids) and will undergo genomic characterization by next-generation sequencing, RNA-sequencing-based transcriptomic profiling, protein expression analyses, advanced imaging, and in-vitro drug response assays. The main goal is to identify and validate molecular biomarkers predictive of progression to PDAC, improve risk stratification of patients with pancreatic precursor lesions, and support the development of innovative precision medicine strategies.",[34,472,473],"Intraductal Papillary Mucinous Neoplasm of Pancreas","Pancreatic Intraepithelial Neoplasia",[30,475,476],"IPMN","PanIN","2026-07-13",{"date":479,"type":51},"2026-07-16",{"date":323,"type":22},{"date":482,"type":22},"2028-09-01",{"name":484,"class":328},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":495,"conditions":496,"keywords":502,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":294},"100619816","phase-1-study-of-rmc-5127-in-patients-with-advanced-kras-g12v-mutant-solid-tumors-100619816","NCT07349537","Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.\n* Measurable per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and\u002For inhibitors).\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":493,"type":22},574,[204],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.",[497,208,35,34,30,498,499,28,500,501],"Non-small Cell Lung Cancer (NSCLC)","CRC","NSCLC","Lung Cancer (NSCLC)","Advanced Solid Tumors",[501,28,32,30,277,498,503,504,499,75,45,76],"Lung Cancer","Non-small Cell Lung Cancer","2026-07-08",{"date":507,"type":51},"2026-07-10",{"date":509,"type":51},"2026-01-08",{"date":511,"type":22},"2028-10",{"name":84,"class":58},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":520,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":306,"phases":4,"briefSummary":522,"conditions":523,"keywords":526,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":116},"100610220","a-noninvasive-and-screening-mirna-signature-for-gastrointestinal-cancer-100610220","NCT07224750","A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer","MiGIC","Inclusion Criteria:\n\n1. Adults aged 18 years or older at the time of blood sample collection.\n2. Patients with a confirmed diagnosis of one of the following gastrointestinal cancers: Hepatocellular carcinoma (HCC), Cholangiocarcinoma (CCA), Pancreatic ductal adenocarcinoma (PDAC), Esophageal squamous cell carcinoma (ESCC), Gastric cancer (GC), Colorectal cancer (CRC), Non-cancer control participants, including healthy volunteers or patients with benign gastrointestinal conditions.\n3. Availability of retrospective blood samples collected according to institutional protocols.\n4. Willingness to allow use of de-identified clinical and demographic data for research purposes.\n\nExclusion Criteria:\n\n* other active malignancies; insufficient sample quality\u002Fvolume; recent chemotherapy\u002Fradiotherapy\u002Fsurgery; any condition preventing reliable participation.",true,{"count":389,"type":22},"Gastrointestinal (GI) cancers remain a major global health burden, largely due to the lack of effective and accessible early screening strategies. Current diagnostic approaches-including endoscopy, computed tomography (CT), and magnetic resonance imaging (MRI)-are either invasive, resource-intensive, or insufficiently sensitive for detecting early-stage disease, and are therefore not suitable for population-wide screening or for simultaneously identifying multiple GI tumor types. As a result, many patients are diagnosed at advanced stages, when therapeutic options are limited and prognosis is poor.\n\nCirculating microRNAs (miRNAs) offer a promising alternative, as they are stable in peripheral blood and reflect tumor-related molecular alterations. In this study, the investigators aim to develop and validate a robust, noninvasive miRNA-based signature capable of distinguishing GI cancers from non-malignant controls. By integrating multi-cohort datasets and applying machine learning-based feature selection and predictive modeling, the investigators will construct a screening panel optimized for reproducibility, scalability, and early-stage detection. This noninvasive miRNA signature has the potential to support accessible, cost-effective, and clinically practical population-level screening for GI cancers, ultimately facilitating earlier diagnosis and improving outcomes for participants.",[396,395,34,524,448,525],"Esophageal Squamous Cell Carcinoma (ESCC)","Colorectal Cancer Screening",[527,528,529,530,531],"Noninvasive screening","Circulating miRNA","Machine learning","Gastrointestinal cancer","Blood-based cancer detection","2026-07-06",{"date":534,"type":51},"2026-07-07",{"date":536,"type":51},"2024-06-21",{"date":538,"type":22},"2028-06-18",{"name":540,"class":328},"City of Hope Medical Center",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":318,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":116},"100646108","phase-2-a-multicenter-single-arm-study-to-evaluate-the-preliminary-efficacy-and-safety-profile-of-inavolisib-in-previously-treated-pancreatic-ductal-adenocarcinoma-patients-100646108","NCT07694973","A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients","Inclusion Criteria:\n\n* 1.Signed Informed Consent Form 2.Age ≥ 18 years at time of signing Informed Consent Form 3.Ability to comply with the study protocol, in the investigator's judgment 4.Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.\n\n  5.The disease must have progressed after previous chemotherapy given in a neoadjuvant, adjuvant (only if distant metastases occurred within 6 months of completing adjuvant therapy), 1st line therapy of locally advanced, or metastatic setting.\n\n  6.Availability of a representative tumor specimen that is suitable for pathological evaluation and biomarker expression analysis.\n* A formalin-fixed, paraffin-embedded (FFPE) tumor specimen in approximately 8-10 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report within 4 weeks of randomization.\n* If fewer than 8 slides are obtained, but there are enough slides for E-cadherin testing by local lab of each site patients are still eligible.\n\n  7.ECOG Performance status (PS) of 0 or 1 within 7 days prior to initiation of study treatment.\n\n  8.At least one measurable lesion per RECIST v1.1 9.Adequate hematologic and organ function, defined by the following laboratory test results, obtained within 7 days prior to initiation of study treatment:\n* ANC ≥ 1.5 × 109\u002FL (1500\u002FμL) without granulocyte colony-stimulating factor support\n* Lymphocyte count ≥ 0.5 × 109\u002FL (500\u002FμL)\n* Platelet count ≥ 100 × 109\u002FL (100,000\u002FμL) without transfusion\n* Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL) Patients may be transfused to meet this criterion, but must not have been transfused within 2 weeks prior to screening\n* Fasting glucose \\\u003C 6.1.mmol\u002FL and HbA1c \\\u003C 5.7%\n* AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN).\n* Total bilirubin ≤ 1.5 × ULN with the following exception:\n\nPatients with known Gilbert disease: total bilirubin ≤ 3 × ULN\n\n* Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n* Albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n* For patients not receiving therapeutic anticoagulation: INR and aPTT ≤ 1.5 × ULN\n* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen 10.Negative HIV test at screening 11.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined below: Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 week after the final dose of study treatment. Women must refrain from donating eggs during this same period.\n\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n12.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for at least 1 week after the final dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, information about the reliability of abstinence will be described in the local Informed Consent Form.\n\nExclusion Criteria:\n\n* 1.Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway.\n\n  2.Prior treatment with any RAS inhibitor or BRCA inhibitor. 3.Known hypersensitivity to any of the components of study treatments. 4.Histology consistent with small cell carcinoma, Neuroendocrine carcinoma, or mixed carcinoma.\n\n  5.Type 2 diabetes requires ongoing systemic treatment at the time of study entry;or pre-diabetes, or any history of Type 1 diabetes；or any other type of diabetes.\n\n  6.Inability or unwillingness to swallow pills 7.Malabsorption syndrome or other condition that would interfere with enteral absorption 8.Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:\n* Measurable disease outside the CNS\n* No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment and no ongoing symptoms attributed to CNS metastases\n* Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic assessments\n* Screening CNS radiographic assessments ≥ 4 weeks since completion of radiotherapy\n* No history of intracranial hemorrhage or spinal cord hemorrhage 9.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently Indwelling pleural or abdominal catheters may be allowed, provided the patient has adequately recovered from the procedure, is hemodynamically stable and symptomatically improved, and has prior approval from the Medical Monitor.\n\n  10.Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1 11.Any concurrent ocular or intraocular condition excluding cataracts (e.g. , diabetic retinopathy) that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition.\n\n  12.Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis, keratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye 13.Requirement for daily supplemental oxygen 14.Symptomatic active lung disease, including pneumonitis 15.History of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Patients currently receiving immunosuppressants for inflammatory bowel disease (e.g., sulfasalazines) are considered to have active disease and are therefore ineligible.\n\n  16.Any active bowel inflammation (including diverticulitis) 17.Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study 18.Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy Bisphosphonate and denosumab therapy for bone metastases or osteopenia\u002Fosteoporosis is allowed.\n\n  19.Clinically significant and active liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis 20.Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic, or infectious disease) or any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that renders the patient at high risk from treatment complications 21.Chemotherapy, radiotherapy, or any other anti-cancer therapy within 2 weeks before study treatment 22.Investigational drug(s) within 4 weeks before study treatment 23.Prior radiotherapy to ≥ 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation 24.Unresolved toxicity from prior therapy, except for hot flashes, alopecia, and Grade ≤ 2 peripheral neuropathy 25.History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer 26.History of or active clinically significant cardiovascular dysfunction, including the following:\n* History of stroke or transient ischemic attack within 6 months prior to first dose of study treatment\n* History of myocardial infarction within 6 months prior to first dose of study treatment\n* New York Heart Association Class III or IV cardiac disease or congestive heart failure requiring medication\n* Uncontrolled arrhythmias, history of or active ventricular arrhythmia requiring medication\n* Coronary heart disease that is symptomatic or unstable angina\n* Congenital long QT syndrome or QT interval corrected through use of Fridericia's formula \\> 470 ms demonstrated by at least two ECGs \\> 30 minutes apart, or family history of sudden unexplained death or long QT syndrome 27.Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia) 28.Chronic corticosteroid therapy of ≥ 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease 29.Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment 30.Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment.\n\nWomen of childbearing potential (including those who have had a tubal ligation) must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment or negative urine pregnancy test if serum pregnancy test is not available.\n\n31.Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1 or anticipation of the need for major surgery during the course of study treatment 32.Minor surgical procedures \\\u003C7 days prior to first dose of study treatment. Patients must have sufficiently recovered from surgery, including adequate wound healing.",{"count":548,"type":22},62,[151],"This is a phase II, multicenter, single arm study designed to evaluate the efficacy and safety of Inavolisib in second line pancreatic ductal adenocarcinoma（PDAC） patients.\n\nThis study will be conducted in two stages and expected to enroll up to approximately 62 patients. In the safety run in stage, approximately up to 12 patients will be enrolled to receive Inavolisib under 3+3 design. After safety run-in, if the tolerability allows, an additional 50 patients will be enrolled.（expansion stage）.\n\nDose Modification Guidelines for Inavolisib-Related Adverse Events: Inavolisib started at dose 9 mg QD, first reduction to 6 mg QD, second reduction to 3 mg QD. If the patient continues to experience specified drug-related adverse events after the second dose reduction, Inavolisib should be permanently discontinued.\n\nTumor assessments will be performed every 8 weeks, including enhanced chest CT, abdominal CT \u002F MRI and pelvic CT \u002F MRI.Head CT\u002FMRI also can be performed if necessary. Additional scans will be performed as clinically indicated.\n\nTumor specimens acquired from biopsy will be collected for E-cadherin testing by IHC at each site. Tumor tissue (via biopsies and\u002For surgical resection) and blood samples from eligible patients will be provided to a local laboratory and tested and analyzed for biomarkers that might be associated with clinical benefit, tumor immunobiology, mechanisms of resistance, et al.\n\nPatients will be closely monitored for adverse events throughout the study, including the incidence, nature and severity of adverse events and laboratory abnormalities graded per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE 5.0).",[34],[553,554,555],"Pancreatic ductal adenocarcinoma (PDAC)","INAVOLISIB","Phase II","2026-07-05",{"date":507,"type":51},{"date":559,"type":22},"2026-08-29",{"date":561,"type":22},"2028-07-29",{"name":563,"class":328},"Fudan University",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":571,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":318,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":4},"100646975","phase-1-mrg003-with-gemcitabine-for-second-line-advanced-pdac-100646975","NCT07685470","MRG003 With Gemcitabine for Second-line Advanced PDAC","A Prospective, Single-arm, Ib\u002FII Exploratory Study of Becotatugvedotin(MRG003) in Combination With Gemcitabine for Second-line Advanced Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\nECOG performance status score of 0-2;\n\nHistopathologically confirmed locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC);\n\nFailure of prior first-line systemic therapy:\n\n1. Radiographic progression or worsening of clinical symptoms; disease progression occurring within 6 months after completion of neoadjuvant\u002Fadjuvant therapy is also considered first-line treatment failure.\n2. Intolerance to first-line therapy, as fully assessed by the investigator, may also allow enrollment into the study. Intolerance to prior study treatment is defined as follows:\n\ni. Any grade ≥3 hematologic toxicity (per NCI-CTCAE v5.0) that does not recover to grade 1 or pre-treatment level after 14 days of best supportive care; ii. Any grade ≥3 non-hematologic toxicity (excluding alopecia and asymptomatic laboratory abnormalities) per NCI-CTCAE v5.0 that does not recover to normal after 14 days of best supportive care.\n\nAdequate organ and bone marrow function;\n\nEstimated life expectancy \\> 3 months;\n\nSubjects must agree to provide sufficient tumor tissue samples for EGFR and PD-L1 immunohistochemistry (IHC) expression testing, next-generation sequencing (NGS), and multi-omics analysis. This includes archived tumor samples (paraffin blocks or unstained sections meeting the testing requirements specified in the study); if no archived tumor tissue sample is available, the subject agrees to undergo re-biopsy of the tumor lesion.\n\nExclusion Criteria:\n\n* Failure of first-line gemcitabine-based therapy.\n\nOther histologic types of pancreatic tumors, such as neuroendocrine tumors, acinar cell carcinoma, cystic carcinoma, etc.\n\nPrior treatment with an MMAE-loaded ADC (antibody-drug conjugate).\n\nCongenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL), or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).\n\nKnown hypersensitivity to the study drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.\n\nOccurrence of the following within 6 months before randomization: myocardial infarction, severe\u002Funstable angina pectoris, New York Heart Association (NYHA) Class ≥2 cardiac insufficiency, or symptomatic congestive heart failure.\n\nVaccination with a live vaccine within 4 weeks before the first dose of study drug. Inactivated virus vaccines for seasonal influenza (administered by injection) are permitted, but live attenuated influenza vaccine administered via the intranasal route is not allowed.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown history of substance abuse (psychoactive drugs) or drug addiction.\n\nPregnant or breastfeeding women.\n\nDiagnosis of any other malignancy within 5 years before study entry, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma that have been treated with local therapy and cured.\n\nPresence of any other serious physical or psychiatric illness, or laboratory abnormalities that may increase the risk of study participation, interfere with the study results, or render the patient unsuitable for participation in the opinion of the investigator.\n\nNote: Subjects with hepatitis B meeting the following criteria may also be enrolled:\n\nHBV viral load \\\u003C 1000 copies\u002FmL (\\\u003C200 IU\u002FmL) before the first dose, and the subject must receive anti-HBV therapy during the entire study treatment period to prevent viral reactivation.\n\nFor subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.\n\nSubjects with active HCV infection (positive HCV antibody and HCV-RNA levels above the lower limit of detection).\n\nVaccination with a live vaccine within 30 days before the first dose (Cycle 1, Day 1).\n\nNote: Inactivated injectable vaccines for seasonal influenza are permitted within 30 days before the first dose; live attenuated influenza vaccine administered intranasally is not allowed.\n\nPresence of any serious or uncontrolled systemic disease, for example:\n\nClinically significant and severe, difficult-to-control abnormalities in cardiac rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation.\n\nUnstable angina pectoris, congestive heart failure, or chronic heart failure of NYHA Class ≥2.\n\nAny arterial thrombotic, embolic, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months before study treatment.\n\nPoorly controlled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg).\n\nActive tuberculosis.\n\nActive or uncontrolled infection requiring systemic therapy.\n\nClinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n\nLiver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.\n\nPoorly controlled diabetes mellitus (fasting blood glucose \\> 10 mmol\u002FL).\n\nUrinalysis showing proteinuria ≥ 2+, with confirmed 24-hour urine protein \\> 1.0 g.\n\nPsychiatric disorders that prevent the patient from cooperating with treatment.\n\nHistory or evidence of disease, treatment, or laboratory abnormalities that could interfere with the study results or prevent the subject from completing full participation in the study, or any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment, including potential risks that are not explicitly listed above.","75 Years",{"count":305,"type":22},[204,151],"This is a Phase Ib\u002FII clinical study aimed to evaluate the tolerability of becotatugvedotin in combination with gemcitabine, determine the clinically recommended dose for the combination regimen, and assess the efficacy and safety of becotatugvedotin combined with gemcitabine in patients with advanced second-line pancreatic ductal adenocarcinoma (PDAC). The study plans to enroll 27-30 patients, including 3-6 patients in the first stage (Phase I) and 24 patients in the second stage (Phase II).\n\nThe study consists of three periods: screening period (including baseline), treatment period, and follow-up period (safety follow-up and survival follow-up). Eligible patients must have locally advanced unresectable or metastatic pancreatic cancer confirmed by histopathology.\n\nPhase I: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. Becotatugvedotin will be administered at doses of 1.5 mg\u002Fkg or 2.0 mg\u002Fkg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg\u002Fm² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II.\n\nPhase II: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. The dose of becotatugvedotin will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg\u002Fm² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Tumor imaging assessments will be performed using RECIST v1.1 every 6 weeks (i.e., every 2 treatment cycles). Safety assessments will be conducted using the NCI-CTCAE version 5.0 criteria from the first dose through 30 days after the last dose.",[34,576],"Second Line Treatment","2026-07-01",{"date":532,"type":51},{"date":580,"type":22},"2026-06-08",{"date":582,"type":22},"2029-06-07",{"name":584,"class":328},"Peking Union Medical College Hospital",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":571,"enrollmentInfo":592,"targetDuration":594,"studyType":306,"phases":4,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":116},"100646959","patient-derived-organoid-on-a-chip-model-for-personalized-prediction-of-chemotherapy-efficacy-in-pancreatic-cancer-100646959","NCT07683845","Patient-Derived Organoid-on-a-Chip Model for Personalized Prediction of Chemotherapy Efficacy in Pancreatic Cancer","A Study on the Consistency Between Patient-Derived Pancreatic Cancer Organoid-on-a-Chip Drug Sensitivity Test Results and Clinical Chemotherapy Efficacy","Inclusion Criteria:\n\n* Age 18-75 years, both sexes\n* Pathologically confirmed pancreatic ductal adenocarcinoma (PDAC) in treatment-naïve patients\n* Ability to obtain sufficient fresh tumor tissue samples for organoid establishment through surgery or biopsy\n* Planned to receive neoadjuvant therapy for borderline resectable disease, conversion therapy for locally advanced disease, or first-line therapy for metastatic disease, using single-agent or combination chemotherapy\n* At least one measurable lesion per RECIST 1.1 criteria\n* ECOG performance status 0-2\n* Life expectancy ≥3 months\n* Adequate organ and bone marrow function: hemoglobin ≥9.0 g\u002FdL; absolute neutrophil count ≥1.5×10⁹\u002FL; platelet count ≥100×10⁹\u002FL; total bilirubin ≤1.5×ULN (or ≤3×ULN with biliary obstruction); ALT\u002FAST ≤2.5×ULN (or ≤5×ULN with biliary obstruction); serum creatinine ≤1.5×ULN or CrCl \\>60 mL\u002Fmin\n* Willing to sign informed consent, good compliance, and able to comply with follow-up\n\nExclusion Criteria:\n\n* Sample quantity, quality, or preservation does not meet requirements\n* Expected transport time \\>24 hours (including samples stored overnight before delivery)\n* Organoid culture failure or testing quality control failure\n* Inability to tolerate chemotherapy regimens\n* Severe comorbidities, uncontrolled conditions, or active infections\n* Pregnancy or breastfeeding\n* History of severe autoimmune diseases\n* Any unstable condition that may compromise patient safety or compliance\n* Deemed unsuitable for inclusion by the investigator",{"count":593,"type":22},164,"18 Months","1. Background Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies worldwide, with a 5-year survival rate below 10%. Systemic chemotherapy is the mainstay of treatment for the majority of patients who present with unresectable disease. However, the objective response rates for standard first-line regimens, such as nab-paclitaxel plus gemcitabine (AG) and FOLFIRINOX, are only 15-30%. Currently, there are no validated predictive biomarkers to guide chemotherapy selection, leading to a trial-and-error approach that exposes patients to unnecessary toxicity and delays effective treatment.\n\n   Patient-derived organoids (PDOs) are three-dimensional in vitro models that recapitulate the genetic, histological, and phenotypic features of their source tumors. PDOs have shown promise as a functional precision medicine platform for predicting individual patient responses to anticancer therapies. Several retrospective and prospective studies across various tumor types have demonstrated high sensitivity and specificity for PDO-based drug sensitivity testing in predicting clinical outcomes. However, prospective data specifically focused on pancreatic cancer remain limited.\n2. Study Objective The primary objective of this study is to evaluate the concordance between PDO-based drug sensitivity test results and clinical efficacy in PDAC patients receiving standard first-line chemotherapy. Secondary objectives include optimizing culture conditions and drug testing protocols for pancreatic cancer PDOs derived from surgical and biopsy specimens.\n3. Study Design This is a prospective, observational, multicenter cohort study. The study will enroll treatment-naïve patients aged 18-75 years with histologically confirmed PDAC who are scheduled to receive first-line chemotherapy. Fresh tumor tissue will be obtained from routine surgical resection or biopsy procedures. PDOs will be established from the collected specimens and subjected to in vitro drug sensitivity testing against the corresponding chemotherapy regimens. The testing results will be classified as \"sensitive\" or \"insensitive\" based on IC50 values and maximum inhibition rates.\n\n   Clinical treatment decisions will be made by the treating physicians according to standard guidelines and multidisciplinary team recommendations, independent of the PDO test results. Patients will be followed up every three treatment cycles with imaging assessments (CT or MRI) and laboratory evaluations. Clinical efficacy will be assessed using RECIST v1.1 criteria after six cycles or at the time of early surgery in the neoadjuvant setting. The concordance between PDO test results and clinical outcomes will be analyzed by calculating sensitivity, specificity, and overall accuracy.\n4. Study Population Approximately 164 patients will be screened to achieve 80 evaluable cases, accounting for a PDO culture success rate of 85%, a follow-up rate of 90%, and exclusions due to non-PDAC pathology or non-first-line treatment regimens. Eligible patients must have adequate organ and bone marrow function, an ECOG performance status of 0-2, and a life expectancy of at least 3 months. Exclusion criteria include inadequate sample quality, PDO culture failure, pregnancy, severe comorbidities, and unstable medical conditions.\n5. Study Sites This multicenter study is being conducted at six tertiary medical centers in China: Ruijin Hospital (Shanghai, lead site), Peking University Cancer Hospital, Beijing Friendship Hospital, The Second Hospital of Tianjin Medical University, The Second Xiangya Hospital of Central South University, and Shenzhen People's Hospital.\n6. Risks and Benefits This observational study poses no additional physical risk to participants, as samples are collected from residual tissue during routine diagnostic or therapeutic procedures. No investigational interventions are administered. Participants will not receive direct medical benefit from study participation; however, the findings may contribute to the development of a clinically applicable predictive tool to guide chemotherapy selection for future pancreatic cancer patients, potentially improving treatment outcomes and quality of life.\n7. Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki and applicable Chinese regulations. The protocol has been reviewed and approved by the institutional ethics committee. Written informed consent will be obtained from all participants prior to enrollment. All data will be anonymized and handled in strict compliance with privacy protection regulations.\n8. Timeline The study is planned from February 2026 to February 2028.",[34],[32,598,599,600,601],"Patient-Derived Organoids","Drug Sensitivity Testing","Precision Medicine","Chemotherapy Response Prediction","2026-06-28",{"date":532,"type":51},{"date":605,"type":51},"2026-02-20",{"date":607,"type":22},"2028-02-20",{"name":609,"class":58},"Beijing Daxiang Biotech Co., Ltd",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":636},"100609679","phase-3-using-18f-fapi-pet-to-detect-metastatic-disease-in-patients-that-have-pancreatic-ductal-adenocarcinoma-pdac-100609679","NCT07217717","Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)","A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET\u002FCT for the Detection of Metastatic Disease in Adults With Pancreatic Ductal Adenocarcinoma","FAPI-PRO","Inclusion Criteria:\n\n* Male and female adults ≥ 18 years.\n* Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2:\n* Provided signed, written informed consent obtained prior to any study-related procedures.\n* Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \\[¹⁸F\\]FAPI-74 administration.\n* For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and\u002For uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner , during the trial intervention period.\n\nExclusion Criteria:\n\n* Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.\n* Known hypersensitivity to \\[¹⁸F\\]FAPI-74.\n* Administration of another investigational therapeutic or diagnostic product within 30 days prior to \\[¹⁸F\\]FAPI-74 administration.\n* Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \\[¹⁸F\\]FAPI-74 administration.\n* Previous cancer diagnosis (except basal cell carcinoma of the skin or in situ carcinoma of the cervix\u002Futerus). Participants treated with curative intent and disease-free for more than 5 years are permitted.\n* Hepatic function: T. bili \\>1.5X ULN or alk phos, ALT, or AST \\>5X ULN\n* Renal function: GFR \\\u003C 30 mL\u002Fmin\n* Pregnant or breast feeding (a negative pregnancy test is required in women of childbearing potential)\n* Inability to undergo the PET\u002FCT scanning procedure.\n* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* Sarcoidosis\n* Treatment, including chemotherapy, radiation or surgery for curative intent of PDAC.",{"count":95,"type":22},[25],"This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \\[¹⁸F\\]FAPI-74 PET\u002FCT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo \\[¹⁸F\\]FAPI-74 PET\u002FCT screening. SOC procedures and interventions will be captured during 3 months +\u002F-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \\[¹⁸F\\]FAPI-74 PET\u002FCT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \\[¹⁸F\\]FAPI-74 PET\u002FCT.",[34],[30,623,624,625,626,627],"FAP","FAPI","PET","Fibroblast Activation Protein","Fibroblast Activation Protein Inhibitor","2026-06-26",{"date":457,"type":51},{"date":631,"type":51},"2025-12-11",{"date":633,"type":22},"2027-12-31",{"name":635,"class":58},"SOFIE",15,{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":643,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":23,"phases":647,"briefSummary":648,"conditions":649,"keywords":655,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":59},"100518120","phase-1-ko-2806-monotherapy-and-combination-therapies-in-advanced-solid-tumors-100518120","NCT06026410","KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors","Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients With Advanced Solid Tumors","FIT-001","Inclusion Criteria:\n\n* At least 18 years of age.\n* Histologically or cytologically confirmed advanced solid tumors\n\n  * Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: HRAS-mutant and\u002For amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and\u002For NRAS, and\u002For HRAS-mutant and\u002For amplified NSCLC or CRC; KRAS-mutant and\u002For amplified PDAC\n  * Arm #2 (Combination): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype; non-clear cell RCC patients who are either treatment-naïve or have received any prior systemic treatment for locally advanced and metastatic RCC.\n  * Arm #3 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC.\n  * Arm #4 (Combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #5 (Cabozantinib monotherapy): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #6 (Cabozantinib rollover to combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #7 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.\n* Acceptable liver, renal, endocrine, and hematologic function.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1.\n* Prior treatment with an FTI or HRAS inhibitor.\n* Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.\n* Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.\n* Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.\n* Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.\n* Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.\n* Inadequate cardiac and\u002For vascular function, including receipt of treatment for unstable angina, myocardial infarction, and\u002For cerebrovascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.\n* Other invasive malignancy within 2 years.\n* Other protocol-defined exclusion criteria may apply.",{"count":646,"type":22},300,[204],"This first-in-human (FIH) dose-escalation and dose-validation\u002Fexpansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.",[650,651,208,34,652,653,654],"Solid Tumors With HRAS Alterations","Non Small Cell Lung Cancer (NSCLC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Renal Cell Carcinoma (Kidney Cancer)","Non Clear Cell Renal Cell Carcinoma (nccRCC)",[132,45,131,656,657,658,659,499,660,661,30,498],"Farnesyltransferase inhibitor (FTI)","Tyrosine Kinase inhibitor (TKI)","Phase 1","KRAS G12C inhibitor","ccRCC","RCC","2026-06-04",{"date":580,"type":51},{"date":665,"type":51},"2023-10-18",{"date":667,"type":22},"2027-04",{"name":669,"class":58},"Kura Oncology, Inc.",{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":4,"eligibilityCriteria":676,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":23,"phases":679,"briefSummary":680,"conditions":681,"keywords":682,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":689,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":697},"100519207","phase-1-study-of-rmc-9805-in-participants-with-kras-g12d-mutant-solid-tumors-100519207","NCT06040541","Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors","Inclusion Criteria:\n\n* Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage\n* ECOG performance status 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Known or suspected leptomeningeal or active brain metastases or spinal cord compression\n* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication\n* Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":678,"type":22},604,[204],"This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.",[497,208,34,501],[683,499,498,30,504,503,277,684,28,685,32,100,686,687,45,688],"KRAS G12D (ON)","Colon Cancer","Metastatic Cancer","Colorectal Neoplasms","Gastrointestinal Neoplasms","Colonic Neoplasms","2026-06-02",{"date":691,"type":51},"2026-06-03",{"date":693,"type":51},"2023-09-07",{"date":695,"type":22},"2027-04-30",{"name":84,"class":58},17,{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":703,"acronym":4,"eligibilityCriteria":704,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":705,"targetDuration":4,"studyType":23,"phases":707,"briefSummary":708,"conditions":709,"keywords":4,"overallStatus":318,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":712,"completionDateStruct":714,"leadSponsor":716,"locationsCount":116},"100637602","phase-1-study-of-lt-010391-in-participants-with-kras-g12d-mutant-solid-tumors-100637602","NCT07624214","Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors","A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation;\n* Failed standard therapy, intolerant to standard therapy, or no standard therapy is available;\n* ECOG Performance Status of 0 or 1;\n* Adequate organ function\n\nExclusion Criteria:\n\n* History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured;\n* Primary central nervous system (CNS) tumors\n* leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion\u002Fexclusion criteria may apply.",{"count":706,"type":22},198,[204],"This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors",[497,208,34,501],"2026-05-31",{"date":691,"type":51},{"date":713,"type":22},"2026-07",{"date":715,"type":22},"2029-04",{"name":717,"class":58},"Leadingtac Pharmaceutical (Shaoxing) Co., Ltd."]