[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-ductal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-ductal-adenocarcinoma":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,83,0,25,[9,60,90,114,141,198,225,254,280,334,361,393,421,449,477,497,519,548,572,608,638,662,687,708,743],{"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":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":73,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100610328","prediction-of-neoadjuvant-chemotherapy-response-in-pancreatic-cancer-100610328","NCT07226154","Prediction of Neoadjuvant Chemotherapy Response in Pancreatic Cancer","An Exosomal miRNA Based Predictive Model for Personalized Neoadjuvant Chemotherapy Selection in Pancreatic Ductal Adenocarcinoma","PRECEPT","Inclusion Criteria:\n\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Underwent neoadjuvant chemotherapy (FOLFIRINOX or Gemcitabine\u002Fnab-paclitaxel).\n* Availability of pre-treatment plasma samples.\n* Underwent curative-intent resection (R0 or R1).\n\nExclusion Criteria:\n\n* Inadequate plasma samples or poor RNA quality for exosomal miRNA analysis.\n* Non-adenocarcinoma histology.\n* Presence of synchronous or multiple primary malignancies.\n* Receipt of chemotherapy regimens other than standard FOLFIRINOX or gemcitabine plus nab-paclitaxel (GEM-NABP).\n* Presence of active inflammatory or autoimmune diseases.",{"count":69,"type":22},200,"OBSERVATIONAL","This study aims to develop and validate a predictive microRNA (miRNA) panel to assess the response to neoadjuvant chemotherapy (NACT) in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC).",[32],[30,74,75,76,77,78],"Exosome","miRNA","FOLFIRINOX","gemcitabine plus nab-paclitaxel","neoadjuvant chemotherapy","2026-08-18",{"date":81,"type":51},"2026-08-19",{"date":83,"type":51},"2024-11-15",{"date":85,"type":22},"2026-12-01",{"name":87,"class":88},"City of Hope Medical Center","OTHER",1,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100567809","phase-1-ptm-101-in-pancreatic-ductal-adenocarcinoma-pdac-100567809","NCT06673017","PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)","A Phase Ib Dose Escalation\u002FDose Expansion Study of PTM-101 as an Adjunct to Neoadjuvant Therapy for Treatment Naïve, Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)","Inclusion Criteria:\n\n* Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology\u002Fcytology either at study-mandated laparoscopy or by prior biopsy\u002Fcytology\n* Indicated for laparoscopy\n* No prior therapy of any kind for PDAC\n* Acceptable laboratory values\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2\n* Ability to provide informed consent\n* No symptomatic pancreatitis\n* No other active medical issues which would confound interpretation of safety monitoring, efficacy results or prevent the subject from study participation\n* Subjects with childbearing potential must agree to use adequate contraception throughout study participation\n\nExclusion Criteria:\n\n* Active non-pancreatic cancer that currently requires treatment or is being treated; diagnosis of another malignancy within the past 2 years. This criterion excludes a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancers, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to screening). Other potentially indolent cancers may be considered.\n* Contraindications or allergies to paclitaxel, PLGA (poly(lactic-co-glycolic ) acid), or contraindications to implantation of PTM-101 or chemotherapies in protocol (e.g., FOLFIRINOX, gemcitabine, nab-paclitaxel)\n* Known history of human immunodeficiency virus (HIV) or active viral hepatitis\n* Active ongoing infection or autoimmune disease which may preclude laparoscopy, placement of PTM-101, administration of chemotherapy or surgical resection of pancreatic tumor\n* Inability to comply with activities and therapeutic interventions as outlined in the schedule of events\n* Currently enrolled in another investigational drug or device trial\n* Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeed; men who plan to donate sperm or conceive a child\n* Any other medical or surgical conditions, including prior abdominal surgery, that would preclude safe laparoscopy or implantation in the opinion of the investigator",{"count":98,"type":22},26,[100],"PHASE1","This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation\u002Fdose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC).",[32,103,104,28],"Borderline Resectable Pancreatic Adenocarcinoma","Locally Advanced Pancreatic Adenocarcinoma","2026-08-17",{"date":79,"type":51},{"date":108,"type":51},"2025-04-14",{"date":110,"type":22},"2028-06",{"name":112,"class":58},"PanTher Therapeutics",8,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100652165","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-with-treatment-combinations-with-telisotuzumab-adizutecan-in-adults-participants-with-pancreatobiliary-cancers-100652165","NCT07769502","A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers","A Phase 2, Open-Label, Master Protocol Study to Evaluate Safety and Efficacy of Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Pancreatobiliary Cancers (AndroMETa-118)","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.\n* Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade \\\u003C= 1 prior to study entry (except for alopecia of any grade).\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nExclusion Criteria:\n\n* Prior cellular-Mesenchymal Epithelial Transition (c-MET) protein targeting therapy\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug induced pneumonitis, or idiopathic pneumonitis.\n* Has had major surgery or significant traumatic injury within 28 days prior to randomization\u002Fenrollment, or anticipation of the need for major surgery during the course of study intervention. Placement of biliary stent\u002Ftube is permitted.",{"count":122,"type":22},168,[124],"PHASE2","Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The goal of this study is to evaluate the safety and efficacy of telisotuzumab adizutecan in combination with gemcitabine and nab-paclitaxel in adult participants with pancreatobiliary cancers.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatobiliary cancers. In Substudy 1, participants will be randomized into two groups. One group will receive different doses of telisotuzumab adizutecan with gemcitabine. The other group will receive standard of care (SOC) - gemcitabine and nab-paclitaxel. Approximately 168 participants will be enrolled in this study in approximately 50 sites worldwide.\n\nSubstudy 1 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage, participants will receive escalating doses of Intravenous (IV) telisotuzumab adizutecan + Gemcitabine. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with Gemcitabine or SOC. The study will run for a duration of approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[127,32],"Pancreatobiliary Cancers",[127,32,30,129,130],"Telisotuzumab Adizutecan","Cancer","NOT_YET_RECRUITING","2026-08-13",{"date":79,"type":51},{"date":135,"type":22},"2026-09-22",{"date":137,"type":22},"2028-11",{"name":139,"class":58},"AbbVie",4,{"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":151,"conditions":152,"keywords":156,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100639442","a-first-in-human-trial-of-blu-924-sar449336-in-advanced-solid-tumors-harboring-kras-mutations-100639442","NCT07629960","A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations","A Phase 1\u002F2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of metastatic Kirsten rat sarcoma viral oncogene homolog (KRAS)-mutant pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) with evidence of a single KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA).\n2. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n4. Patients must have received all standard therapies for their cancer type in the metastatic setting, unless they are unable to receive such therapies due to clinical characteristics, comorbidities, or other medically justified reasons.\n\nExclusion Criteria:\n\n1. History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.\n2. Active brain metastases (participants with asymptomatic brain metastases may be eligible).\n3. Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.\n4. Active or uncontrolled systemic infection, such as tuberculosis, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":149,"type":22},265,[100,124],"A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 \u002F SAR449336, a pan-KRAS inhibitor, in participants with advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer harboring KRAS mutations.",[153,154,155,32],"Advanced Solid Tumor","Non-Small Cell Lung Cancer","Colorectal Neoplasms",[157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,30,183,184,185,186,187],"Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","Metastatic Pancreatic Ductal Adenocarcinoma","KRAS G12A","KRAS G12C","KRAS G12D","KRAS G12S","KRAS G12V","Solid Tumor, Adult","KRAS-mutant","KRAS-positive","KRAS G13D","Pan-KRAS inhibitor","KRAS inhibitor","First-in-human","Solid tumor","Advanced cancer","Adult solid tumor","Metastatic solid tumor","Colorectal cancer","Colon cancer","Rectal cancer","Metastatic colorectal cancer","Pancreatic cancer","Pancreatic ductal adenocarcinoma","Metastatic pancreatic cancer","Lung cancer","NSCLC","Precision oncology","Targeted therapy","2026-08-06",{"date":190,"type":51},"2026-08-10",{"date":192,"type":51},"2026-06-04",{"date":194,"type":22},"2031-07",{"name":196,"class":58},"Blueprint Medicines Corporation",2,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100449440","phase-2-neoadjuvant-folfirinox-combined-with-pembrolizumab-followed-by-surgery-for-patients-with-resectable-pancreatic-cancer-100449440","NCT05132504","Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer","Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Pembrolizumab Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas","Inclusion Criteria:\n\n1. Patient is ≥18 years of age and has histologically or cytologically confirmed localized adenocarcinoma of the pancreas that is potentially resectable. Patients with islet cell or other neuroendocrine neoplasms are excluded.\n2. Definition of localized, potentially resectable disease: a) Adequate CT or MRI to determine staging and eligibility based on radiologic interpretation. b) No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior mesenteric vein\u002Fportal vein (SMV\u002FPV) with \\\u003C 180-degree abutment and no evidence of invasion. c) Clear fat plane between the SMA and celiac axis. d) No extension to celiac axis and hepatic artery. e) Patent superior mesenteric vein and portal vein. f) No evidence of distant metastatic disease 3. If a female patient is of childbearing potential, she must have a negative urine pregnancy test documented within 72 hours of first intervention. 4. Fertile participants must use contraception considered adequate and appropriate as stated in Appendix 3 (pages 61-62).\n\n5\\. Male participants: A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 220 days after the last dose of study treatment and refrain from donating sperm during this period.\n\n6\\. Patient must not have received prior chemotherapy or radiation for pancreatic cancer. 7. Patient has an ECOG performance status PS 0-1. 8. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form before participation in any study-related activities.\n\n9\\. A female participant is eligible to participate if:\n\na. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 (pages 61-62). OR b. A WOCBP who is not pregnant, not breastfeeding, and agreeing to use proper contraception defined by the protocol (Appendix 3 \\[pages 61 - 62\\] and Table 18 \\[page 63\\]) for at least 160 days after the last dose of study treatment.\n\n10\\. Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 14 days before the start of interventions.\n\nHematological Absolute neutrophil count (ANC) ≥1500\u002FμL Platelets ≥100 000\u002FμL Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FLa Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\n1. Patient has borderline resectable, locally advanced unresectable, or advanced metastatic disease. Patients with neuroendocrine tumors, adenosquamous cancer, lymphoma of the pancreas, or ampullary cancer are also ineligible.\n2. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.\n3. Patient has known infection with HIV.\n4. Patient has undergone major surgery, other than diagnostic surgery (-e.g. diagnostic laparoscopy or placement of a central venous catheter), within 4 weeks before registration.\n5. Patient has a history of allergy or hypersensitivity to the study drugs.\n6. Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and\u002For radiation therapy.\n7. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n8. Patient has had clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before registration.\n9. Patient is unwilling or unable to comply with study procedures.\n10. Patient is enrolled in any other therapeutic clinical protocol or investigational trial.\n11. Patients aged ≥ 80 are not excluded. However, candidates in this age group should be thoroughly evaluated before registration in the study, to ensure they are fit to receive chemotherapy, and to potentially undergo pancreaticoduodenectomy. In addition to meeting all of the baseline patient selection criteria, clinical judgment on their susceptibility to infection and expected stability of their performance status and suitability to receive intensive chemotherapy cycles, should be paid special attention to. Patients should not be enrolled in the study should there be any hesitation on any of these considerations. Baseline criteria for all patients enrolled in the study must be carefully evaluated and all criteria followed appropriately.\n12. Patient has evidence of peripheral neuropathy Grade 2 or higher.\n13. A WOCBP who has a positive urine pregnancy test within 72 hours prior to first intervention (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a second urine pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another urine pregnancy test must be performed and must be negative in order for the subject to start receiving study medication.\n14. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n15. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.\n16. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n17. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n18. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n19. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n20. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as detectable HCV by RNA) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authorities.\n21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n23. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":206,"type":22},30,[124],"Abbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional prospective Type of control: Historical Route of administration: IV Treatment Groups: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Number of trial participants: 30 Estimated enrollment period: 24 months Estimated duration of trial: 3.5 Years Duration of Participation:16 months Estimated average length of treatment per patient: 16 months",[32],[211,212,213,214],"pembrolizumab","pancreatic cancer","pancreas adenocarcinoma","folfirinox","2026-08-03",{"date":217,"type":51},"2026-08-04",{"date":219,"type":51},"2022-08-31",{"date":221,"type":22},"2027-05-21",{"name":223,"class":88},"Baylor College of Medicine",3,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100439243","phase-1-ab122-platform-study-100439243","NCT04999761","AB122 Platform Study","Platform Study of AB122 Based Treatments in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;\n* Has adequate organ function as defined by the following criteria:\n\n  • AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN\n  * T-Bil of ≤ 1.5 × ULN\n  * ANC ≥ 1500 \u002Fmm3 (ie, ≥ 1.5 × 109 \u002FL by International System of Units \\[SI\\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \\[G-CSF\\])\n  * Platelet count ≥ 100000 \u002Fmm3 (SI: ≥ 100 × 109 \u002FL) (excluding measurements obtained within 7 days after a transfusion of platelets)\n  * Hemoglobin value of ≥ 9.0 g\u002FdL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood\n* Has a life expectancy of at least 90 days;\n\nCohort A-1 and A-2\n\n* Japanese male and female;\n* Has a histologically or cytologically confirmed diagnosis of solid tumor;\n* Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;\n\nCohort B-1\n\n* Has a histologically or cytologically confirmed diagnosis of PDAC;\n* Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease\n\nCohort B-2\n\n* Has a histologically or cytologically confirmed diagnosis of CRC.\n* Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy\n\nCohort B-3\n\n* Has a histologically or cytologically confirmed non-squamous NSCLC;\n* Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment\n* Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met:\n\n  * Received at least 2 doses at the most recent ICI therapy\n  * Radiographic complete response or partial response based on investigator assessment with ICI therapy\n  * Documented radiographic disease progression with above most recently received regimen\n\nCohort C-1\n\n* Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma\n* Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).\n* Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):\n\n  * fluoropyrimidines and platinum\n  * taxane or irinotecan\n  * ramucirumab\n\nCohort C-2 - Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)\n\n* RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \\[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\\].\n* Has received at least 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose , or intolerance to their last regimen, and all of the following criteria must be met:\n\n  * Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody\n  * For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above\n\nCohort D-1\n\n* Has histologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.\n\nCohort D-2\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease.\n\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-3\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease, or refractory or intolerant to at least 1 cycle of standard first-line therapy.\n\n  * Treatment discontinued due to intolerable toxicity or because the same drug cannot be re-treated before the disease progresses is considered as intolerable to the previous treatment.\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-4\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  • The confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n\n  • Patient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-5\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the HPV in cancers of the mid-pharynx.\n  * Patient background such as CPS and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-6\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous NSCLC.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-7\n\n* Has histologically confirmed unresectable or advanced biliary tract cancer (intrahepatic bile duct, extrahepatic bile duct, gallbladder, or duodenal papillary region) with a diagnosis of adenocarcinoma or adenosquamous carcinoma.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-8\n\n* Has histologically confirmed unresectable or advanced pancreatic ductal adenocarcinoma (highly differentiated, moderately differentiated, or poorly differentiated).\n* No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-9 - Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\nThe confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n\nPatient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n\n\\- No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nTreatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort E-1\n\n* Has a histologically or cytologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).\n* Has been received 1-4 regimen for advanced or metastatic disease\n* Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met:\n\n  * Received at least 2 doses of the ICI therapy\n  * Documented radiographic disease progression with or after ICI therapy\n\nCohort E-2\n\n* Has a histologically or cytologically confirmed advanced or metastatic ASPS\n* Is male or female aged ≥ 16 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedure\n\nExclusion Criteria:\n\n* Clinically significant history or current evidence of cardiac arrhythmia and\u002For conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;\n* Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:\n\n  * Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);\n  * Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;\n  * Any anticancer therapy within 2 weeks;\n  * Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;\n* Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);\n* A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:\n\n  * Known acute systemic infection;\n  * Known medical history of interstitial lung disease\u002F drug-induced interstitial lung disease\u002F radiation pneumonitis which required steroid treatment\u002F any evidence of clinically active interstitial lung disease;\n  * Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV, Appendix A) within the previous 6 months; if \\> 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;\n  * Known severe chronic kidney disease;\n  * Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;\n* Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated \\> 5 years prior to the day on which study treatment is scheduled to be started;\n* WOCBP or male patients who do not agree to effective birth control during the following period\n\n  1. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n  2. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n* Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohort B-3, C-1, D-1 tolerability part and E-1).\n* Has received a live vaccine within 30 days prior to study treatment including, but not limited to the following examples: measles, mumps, rubella, varicella-zoster, yellow fever, and BCG. The inoculation with inactivated vaccines for seasonal influenza is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to enrollment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient\\'s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. (eg, paresis of intestine, intestinal obstruction, unable to receive 5% dextrose in water \\[DW\\] in patients with diabetes mellitus, respiratory failure, renal failure, hepatic failure, cerebrovascular disorder, gastrointestinal ulcers that require transfusion or are hemorrhagic, and wounds\u002Fbone fractures associated with neovascularization during the healing process, accumulation of pleural within 2 weeks prior to enrollment, ascitic, or pericardial fluid requiring drainage)",{"count":233,"type":22},917,[100],"This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.",[237,32,238,239,240,241,242,243,244],"Advanced or Metastatic Solid Tumor","Colorectal Cancer","Non-small Cell Lung Cancer","Gastric Cancer","Alveolar Soft Part Sarcoma","Esophageal Cancer","Head and Neck Cancer","Biliary Tract Cancer",{"date":246,"type":51},"2026-08-05",{"date":248,"type":51},"2021-06-01",{"date":250,"type":22},"2027-06",{"name":252,"class":58},"Taiho Pharmaceutical Co., Ltd.",9,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":268,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":89},"100650128","phase-2-safety-and-efficacy-of-multimodal-thermal-therapy-mtt-combined-with-kras-g12v-mrna-vaccine-s-1-and-sintilimab-in-patients-with-metastatic-pancreatic-cancer-100650128","NCT07745790","Safety and Efficacy of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab in Patients With Metastatic Pancreatic Cancer","A Study of Multimodal Thermal Therapy (MTT) Combined With KRAS G12V mRNA Vaccine, S-1, and Sintilimab for Safety and Efficacy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Disease Progression After or Are Intolerant to Standard First-Line Therapy","Inclusion Criteria:\n\n* Aged ≥ 18 years old with no restriction on gender.\n* Patients with advanced pancreatic cancer or postoperative recurrent pancreatic cancer confirmed by histopathological or cytological examination.\n* Tumor tissues are confirmed to carry KRAS G12V mutation via sequencing and bioinformatics analysis (valid test reports obtained within the previous 12 months and recognized by the investigator are acceptable). In the dose expansion phase, patients must harbor at least one HLA allele capable of effectively presenting the corresponding antigen, including HLA-A11:01, HLA-A03:01, HLA-A30:01, HLA-A68:01, HLA-C01:02, HLA-C03:03, and HLA-C03:04.\n* Disease resistance or intolerance to prior AG-based chemotherapy regimens.\n* Presence of liver metastasis or lung metastasis.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n* Child-Pugh score ≤ 7 points.\n* Expected overall survival of at least 3 months.\n\nExclusion Criteria:\n\n* Presence of diffuse hepatic or pulmonary metastases.\n* Prior local treatment including radiofrequency ablation, microwave ablation, radiotherapy or other local therapies for metastatic lesions.\n* Current participation in other interventional clinical studies and receiving investigational treatment.\n* Diagnosis of any other malignant disease within 5 years prior to the first study drug administration (excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and\u002For radically resected in situ carcinoma).\n* Prior history of solid organ or hematopoietic stem cell transplantation.\n* Any disease requiring systemic treatment with corticosteroids (prednisone or equivalent daily dose \\> 10 mg) or other immunosuppressive agents within 14 days prior to enrollment.\n* Previous or current diagnosis of brain metastases with incompletely controlled symptoms (i.e., persistent or aggravated symptoms, or requirement for adjusted symptomatic treatment to maintain symptom relief).\n* Presence of uncontrolled active infection.\n* Renal dysfunction defined as serum creatinine \\> 176.8 μmol\u002FL or creatinine clearance \\\u003C 30 mL\u002Fmin.\n* Uncorrectable coagulation abnormalities, including platelet count \\\u003C 50×10⁹\u002FL, prothrombin time \\> 18 seconds, or prothrombin activity \\\u003C 40%, which cannot be corrected.\n* History of esophagogastric variceal rupture without effective treatment via endoscopy, interventional therapy or surgery.\n* Patients with psychiatric disorders in the acute episode stage.\n* Women of childbearing potential who are pregnant, breastfeeding, or planning to become pregnant during the study treatment period or within 3 months after the end of study treatment.\n* Prior systemic pharmacotherapy, radiotherapy or local hepatic treatment with an interval of \\\u003C 1 month from the last systemic or local hepatic treatment to the first study drug administration.",{"count":262,"type":22},20,[124],"This is a single-arm, single-center, exploratory clinical study. A total of 20 participants with metastatic pancreatic ductal adenocarcinoma (with liver or lung metastasis) who have experienced disease progression after or are intolerant to standard first-line chemotherapy (based on the AG regimen \\[Albumin-bound Paclitaxel plus Gemcitabine\\]) will be enrolled.The study aims to evaluate the safety, efficacy, and underlying immunological mechanisms of Multimodal Thermal Therapy (MTT) combined with a KRAS G12V mRNA vaccine, S-1, and Sintilimab.",[32,266,267],"Liver Neoplasms","Lung Neoplasms",[269,270,271],"Multimodal Thermal Therapy","mRNA","Metastatic Pancreatic Cancer","2026-07-30",{"date":217,"type":51},{"date":275,"type":22},"2026-07-13",{"date":277,"type":22},"2029-07-31",{"name":279,"class":88},"Ruijin Hospital",{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100525962","phase-1-study-of-elironrasib-and-daraxonrasib-as-monotherapies-and-combination-therapy-in-participants-with-advanced-kras-g12c-mutant-solid-tumors-100525962","NCT06128551","Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors","Phase 1b\u002F2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors","Inclusion Criteria:\n\n* 18 years of age\n* Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy\n\n  1. Phase 1b Dose Escalation: solid tumors, previously treated\n  2. Phase 1b Dose Expansion and Phase 2:\n\n  i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.\n* ECOG performance status 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Active brain metastases\n* Known impairment of GI function that would alter the absorption\n* Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment",{"count":288,"type":22},534,[100,124],"This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.",[292,238,32],"Non-Small Cell Lung Cancer (NSCLC)",[294,295,45,296,297,187,298,299,267,300,239,301,185,238,302,303,304,305,306,307,308,309,310,311,312,313,314,315,28,316,30,317,318,242,319,240,320,321,322,323,324,325],"RMC-6291","RAS (ON)","KRASG12C","KRASG12C (ON)","Metastatic Cancer","Lung Cancer","Thoracic Neoplasms","Carcinoma, Non-Small Cell Lung","Colonic Neoplasms","CRC","Appendiceal Cancer","KRAS mutation","STK11\u002FLKB1","KEAP1","Bronchial neoplasms","Respiratory tract neoplasms","Neoplasms by site","Neoplasms","Colon Cancer","Rectal Cancer","Lung disease","Respiratory tract diseases","Carcinoma, Pancreatic Ductal","Gastrointestinal Neoplasms","Intestinal Neoplasms","Ampullary Cancer","Gynecological Cancer","Ovarian Cancer","Endometrial Cancer","RMC-6236","Elironrasib","Daraxonrasib",{"date":215,"type":51},{"date":328,"type":51},"2023-11-14",{"date":330,"type":22},"2029-06",{"name":332,"class":58},"Revolution Medicines, Inc.",55,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":351,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":358,"locationsCount":360},"100412938","phase-1-a-study-of-art0380-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100412938","NCT04657068","A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors","General Inclusion Criteria:\n\n* Signed informed consent\n* Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.\n* If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated\n* At least 1 radiologically evaluable lesion (measurable and\u002For non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)\n* Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor\n* Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.\n* Female patients of childbearing potential and male patients with female partners of childbearing potential are required to use highly effective contraception plus one barrier method during their participation in the study and for 7 months and 5 months respectively following the last dose. For male and female patients given gemcitabine or irinotecan, highly effective contraception plus one barrier method must be used from study entry until 6 months after the last dose of study treatment. Male patients are required to refrain from donating sperm and female patients are required to refrain from donating eggs, during their participation in the study and for 6 months following last dose.\n* Estimated life expectancy of ≥12 weeks\n* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Performance status of 0-1 on the ECOG Scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A1):\n\n* Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study\n* Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A2):\n\n•Advanced or metastatic cancer for which gemcitabine is an appropriate treatment. Prior treatment with gemcitabine is permitted.\n\nAdditional inclusion criteria for participants in dose escalation (Part A3):\n\n* Advanced or metastatic cancer for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For food effect cohort only: Patients must be able to eat a high-fat meal within a 30 minute period, as provided by the study site.\n\nAdditional inclusion criteria for participants in dose expansion (Part B1):\n\n* Patients with advanced or metastatic solid tumors with alterations to the ATM gene likely to predict for loss of ATM protein\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n* For France only ART0380 Monotherapy; Patient that is not eligible for curative treatment, for whom all standard of care therapies have failed and no therapies known to provide clinical benefit are available.\n* Combination arms; Patients for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For Spain only ART0380 Combination therapy, Patient that is not eligible for curative treatment, for whom standard of care therapies have failed.\n\nAdditional inclusion criteria for participants in dose expansion (Part B2):\n\n* Patients with a known germline BRCA mutation, or a cancer with a known somatic BRCA mutation, or which is known to be HRD positive, and for which there is an approved PARP inhibitor should have received such treatment before participating in the study, unless contra-indicated.\n* Females with histologically-confirmed diagnosis of high grade serous carcinoma of the ovary, fallopian tube or primary peritoneum that is not amenable to curative therapy\n* Platinum-resistant disease. Patients must not have had primary platinum-refractory disease (disease that progressed during first-line platinum-based therapy).\n* No more than one prior regimen in the platinum-resistant setting. Hormonal therapies and antiangiogenic therapies (as single agents) and PARP inhibitors used as maintenance therapy are not considered as separate lines of therapy. Patients should have previously received bevacizumab and chemotherapy unless contra-indicated.\n* Have not received prior treatment with gemcitabine unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n\nInclusion criteria specific to Part B3\n\n* Persistent or recurrent endometrial cancer with biological selection.:\n* Patients should have received taxane\u002Fplatinum chemotherapy, unless contraindicated.\n* Measurable disease.\n\nInclusion criteria specific to Part B4\n\n* Advanced or metastatic solid cancers of any histology with biological selection\n* If a PD-1\u002FPDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study.\n* Radiologically evaluable disease\n* Performance status of 0-1 on the ECOG scale\n\nInclusion criteria specific to Part B5\n\n* Metastatic CRC with alterations to the ATM gene\n* Participants should have previously received appropriate prior lines of therapy in this setting.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1.\n* Patients have received a maximum of 2 prior chemotherapy regimens for the treatment of CRC.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n* ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.\n* Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease\n\nInclusion criteria specific to Part B6:\n\n* Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene\n* Participants must have received at least 1 prior chemotherapy regimen for the treatment of the advanced disease OR have received neoadjuvant\u002Fadjuvant therapy with recurring occurring \\\u003C6 months following completion of this treatment.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Previously irradiated lesions may not be considered target lesions.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n* ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.\n* Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease.\n\nGeneral Exclusion Criteria:\n\n* Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment\n* Men who plan to father a child while in the study or within5 months after the last administration of study treatment\n* Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV\u002FAIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission\n* Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).\n* Moderate or severe cardiovascular disease\n* Valvulopathy that is severe, moderate, or deemed clinically significant\n* Documented major electrocardiogram (ECG) abnormalities which are clinically significant\n* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment\n* Received a live vaccine within 30 days before the first dose of study treatment\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate\n* Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study\n* Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks before the first dose of study treatment.\n* A significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment\n* Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study\n\nAdditional exclusion criteria for participants in dose escalation (Part A3, B1, B5, and B6 in combination with irinotecan):\n\n* Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening.\n* Patients who are known to be homozygous for both UGT1A1 \\*6 and \\*28 (UGT1A1 7\u002F7 genotype), or simultaneously heterozygous for both UGT1A1 \\*6 and \\*28.\n* Patients receiving strong inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment\n* Part A3 Fed-fasted cohort only: Patients receiving acid reducing agents within 1 week before the first dose of study treatment will be excluded\n* Part B6: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer\n* Parts B5 and B6: Initiation of opioids in the previous 2 weeks.\n* Parts B5 and B6: Weight loss \\>10% in the previous 8 weeks.\n* Parts B5 and B6: Active intestinal obstruction, ileus, or significant malabsorption.",{"count":342,"type":22},542,[100,124],"This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:\n\n* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan\n* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan\n* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan",[346,298,321,347,348,322,349,32,350],"Advanced Cancer","Primary Peritoneal Cancer","Fallopian Tube Cancer","Metastatic Colorectal Cancer","Acinar Cell Carcinoma",[352],"Loss of Ataxia Telangiectasia Mutated (ATM) protein","2026-07-29",{"date":272,"type":51},{"date":356,"type":51},"2021-01-27",{"date":110,"type":22},{"name":359,"class":58},"Artios Pharma Ltd",82,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":392},"100559289","phase-1-phase-i-study-of-177lulu-nns309-in-patients-with-pancreatic-lung-breast-and-colorectal-cancers-100559289","NCT06562192","Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers","Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with one of the following indications:\n* Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic HR+\u002FHER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy\n* Patients must have lesions showing 68Ga-NNS309 uptake\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL, hemoglobin \\\u003C 9 g\u002FdL, or platelet count \\\u003C 100 x 10\\^9\u002FL\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* Calculated estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73m2\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Radiation therapy within 4 weeks prior to the first dose of \\[177Lu\\]Lu-NNS309\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":370,"type":22},162,[100],"The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[177Lu\\]Lu-NNS309 and the safety, dosimetry and imaging properties of \\[68Ga\\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+\u002FHER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).",[32,239,374,375,238],"HR+\u002FHER2- Ductal and Lobular Breast Cancer","Triple Negative Breast Cancer",[377,378,379,380,381,382,383],"pancreatic ductal adenocarcinoma","non-small cell lung cancer","breast cancer","colorectal cancer","radioligand therapy (RLT)","[177Lu]Lu-NNS309","[68Ga]Ga-NNS309","2026-07-28",{"date":353,"type":51},{"date":387,"type":51},"2024-10-15",{"date":389,"type":22},"2031-01-16",{"name":391,"class":58},"Novartis Pharmaceuticals",29,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},"100550283","phase-1-study-of-rason-inhibitors-in-patients-with-gastrointestinal-solid-tumors-100550283","NCT06445062","Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","Inclusion Criteria:\n\nAll Patients (unless otherwise noted):\n\n* ≥ 18 years of age\n* ECOG PS is 0 to 1\n* Adequate organ function as outlined by the study\n* Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C)\n* Presence of RAS G12D mutation (Subprotocol D, E, F)\n\nExclusion Criteria:\n\nAll Patients:\n\n* Primary central nervous system (CNS) tumors\n* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs\n* Major surgery within 28 days of first dose\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":401,"type":22},1130,[100,124],"The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.\n\nThe current subprotocols include the following:\n\nSubprotocol A: RMC-6236 + 5-fluorouracil-based regimens\n\nSubprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6\n\nSubprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel\n\nSubprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens\n\nSubprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6\n\nSubprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel",[238,303,32,30,405,160],"Gastrointestinal Cancer",[303,30,407,408,238,28,409,410,411,412,413],"RAS Mutation","KRAS G12X","Pancreatic Ductal Carcinoma","KRAS Q61 Mutation","KRAS G12 Mutation","RAS Wild-type","RAS G12D Mutation",{"date":353,"type":51},{"date":416,"type":51},"2024-05-24",{"date":418,"type":22},"2027-07-15",{"name":332,"class":58},32,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":434,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":448},"100532986","phase-2-azd0901-in-participants-with-advanced-solid-tumours-expressing-claudin182-100532986","NCT06219941","AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2","A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)","The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.\n\nMaster Inclusion Criteria applicable to all sub studies:\n\n* Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.\n* Participants who are CLDN18.2 positive.\n* Must have at least one measurable lesion according to RECIST v1.1.\n* ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.\n* Predicted life expectancy of ≥ 12 weeks.\n* Adequate organ and bone marrow function as defined by protocol.\n* Body weight \\> 35 kg.\n* Participants are willing to comply with contraception requirements.\n\nSub study 1 Specific Inclusion criteria:\n\n* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* Advanced or metastatic GC\u002FGEJC.\n* Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nSub study 2 Specific Inclusion criteria:\n\n* Participants diagnosed with histologically confirmed metastatic or advanced PDAC.\n* Availability of an archival sample or a fresh tumour biopsy taken at screening.\n* No prior treatments for unresectable or metastatic disease. Prior neoadjuvant\u002Fadjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.\n\nSub study 3 Specific Inclusion criteria\n\n* Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).\n* Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nMaster Exclusion Criteria applicable to all sub studies:\n\n* Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n* Participants with clinically significant ascites that require drainage.\n* A history of drug-induced non-infectious ILD\u002Fpneumonitis.\n* Central nervous system metastases or CNS pathology.\n* Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.\n* History of another primary malignancy.\n* Prior exposure to any MMAE-based ADC.\n* Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.\n\nSub study 1 Specific Exclusion criteria:\n\n* Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC\u002FGEJC unless they have failed\u002Fnot tolerated\u002For are not eligible for standard anti-HER2 therapy, where available.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.\n* The use of concomitant medications known to prolong the QT\u002FQTc interval.\n\nSub study 2 Specific Exclusion criteria:\n\n* Known DPD enzyme deficiency based on local testing where testing is SoC.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Use of strong inhibitors or inducers of CYP3A4.\n* Known homozygous for the UGT1A1\\*28 allele based on local testing where testing is SoC.\n\nSub study 3 Specific Exclusion criteria\n\n• Clinically significant biliary obstruction that has not resolved before enrollment.",{"count":429,"type":22},226,[124],"The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.",[240,433,244,32],"Gastroesophageal Junction Cancer",[435,436,437,244,438,439,440],"Gastric cancer","Gastroesophageal junction cancer","Pancreatic Ductal adenocarcinoma","Phase II","Claudin 18.2","AZD0901",{"date":353,"type":51},{"date":443,"type":51},"2023-12-13",{"date":445,"type":22},"2027-06-28",{"name":447,"class":58},"AstraZeneca",52,{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":476},"100532907","phase-1-phase-1-study-to-investigate-tcrts-kras-mutation-in-unresectable-advanced-andor-metastatic-solid-tumors-100532907","NCT06218914","Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor\n* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\\*08:02 positive, HLA-A\\*11:01 or HLA-A\\*11:02 positive in at least one allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Presence of at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n\nKey Exclusion Criteria:\n\n* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment\n* Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.",{"count":457,"type":22},108,[100],"Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and\u002For Metastatic Solid Tumors.",[239,461,32,322,166,163],"Colorectal Carcinoma",[463,45,163,464,30,185,238,465,32,466,467,468],"TCR-T cell therapy","Autologous","Solid tumors","HLA-C*08:02","HLA-A*11:01","HLA-A*11:02","2026-07-27",{"date":384,"type":51},{"date":472,"type":51},"2024-03-22",{"date":474,"type":22},"2043-11-18",{"name":447,"class":58},18,{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":197},"100540736","ai-derived-biomarker-to-select-neoadjuvant-treatment-for-borderline-resectable-pancreatic-ductal-adenocarcinoma-100540736","NCT06320717","AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma","A Retrospective\u002FProspective Study of an Artificial Intelligence Derived Histological Biomarker to Select Neoadjuvant Treatment for Patients With Borderline Resectable or Resectable Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that is resectable (Cohort B) using the National Comprehensive Cancer Network criteria \\[35\\].\n* Availability of archival tumor tissue (diagnostic for PDAC) required\n* Have a documented ECOG Performance Status of ≤ 1\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form (ICF) prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Has received prior systemic treatment (standard of care or experimental) for PDAC\n* Participant has a concurrent malignancy requiring active treatment during the study.",{"count":485,"type":22},100,"To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.\n\nThe information collected will be used to determine if there are any \"biomarkers\" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.",[32],"2026-07-22",{"date":490,"type":51},"2026-07-23",{"date":492,"type":51},"2024-01-02",{"date":494,"type":22},"2026-12-02",{"name":496,"class":88},"Roswell Park Cancer Institute",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":89},"100637261","phase-1-study-of-ibi3028-in-participants-with-locally-advanced-unresectable-or-metastatic-solid-tumors-100637261","NCT07589205","Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors","A Phase 1, Multi-Center, Open-Label Study Evaluating IBI3028 Treatment in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Be able to understand and sign written informed consent to participate in this study, including all assessments and procedures specified in this protocol;\n2. Male or female participants aged 18 years or older;\n3. Have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors;\n4. Have at least one evaluable lesion (dose escalation) or measurable lesion (dose expansion) as per RECIST v1.1 within 28 days prior to the first dose of IBI3028;\n5. ECOG PS（Eastern Cooperative Oncology Group Performance Status）score of 0-1;\n6. Anticipated life expectancy of ≥ 12 weeks;\n7. Adequate bone marrow and organ function as evidenced by :\n\n   1. Hematological function: ANC(Absolute neutrophil count) ≥ 1.5 × 10 9 \u002FL; platelet count (PLT) ≥ 90 × 10 9 \u002FL; hemoglobin ≥ 9.0 g\u002FdL, and without receiving granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), thrombopoietin (TPO), interleukin-11, or other leukocyte\u002Fplatelet stimulating growth factors (including red blood cell and platelet transfusions) within at least 7 days before the first dose of the study drug;\n   2. Hepatic function: total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) (≤ 3 × ULN for participants with Gilbert's syndrome); AST(Aspartate Aminotransferase) and ALT (Alanine Aminotransferase)≤ 2.5 × ULN in the absence of liver metastases (≤ 5 × ULN if liver metastases are present); albumin ≥ 2.8 g\u002FdL;\n   3. Renal function: creatinine clearance ≥ 30 mL\u002Fmin (using Cockcroft-Gault formula); urine protein \\\u003C 2+ or 24-h total urine protein \\\u003C 1 g;\n   4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion as determined by ECHO or MUGA(Multigated Acquisition), and no clinically significant ECG result;\n   5. Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (participants receiving anticoagulant therapy with coagulation function within the range above are allowed);\n   6. Pulmonary function: With at least the lowest level of pulmonary reserve, defined as Grade ≤ 1 dyspnea and blood oxygen saturation ≥ 95% in non-oxygen breathing state;\n8. Participants (both male and female participants) who will be not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study (from start of screening or within 2 weeks prior to first dose, whichever occurs first, and continue until 7 months for females and 4 months for males after the last dose of study drug).\n\nExclusion Criteria\n\n1. Participation in any other interventional clinical study other than an observational (non-interventional) study or during the follow-up period of an interventional study;\n2. Prior anti-tumor therapy:\n\n   Participants who have received cytotoxic therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first administration of study intervention ; Participants who have received PD-1\u002FPD-L1 therapy within 4 weeks prior to the first administration of study drug; Participants who have received treatment with small molecule targeted therapy within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of the study drug; Palliative radiation therapy within 2 weeks or radical radiation therapy within 4 weeks prior to the first dose of study drug; Participants who had received adoptive cell therapy within 8 weeks prior to the first administration of study intervention.\n3. Have received live vaccines within 4 weeks or tumor vaccines within 3 months prior to the first administration of the study drug, or plan to receive any live vaccines during the study;\n4. Use of strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitors within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug;\n5. Adverse reactions caused by previous anti-tumor treatments that have not resolved to Grade 0 or 1 or baseline level according to NCI CTCAE v5.0 before the first dose of the study drug (except for alopecia, fatigue, pigmentation, and other conditions with no safety implications per the Investigator's clinical judgement);\n6. Known allergies, hypersensitivity, or intolerance to IBI3028 or its excipients (refer to the Investigator's Brochure);\n7. Have undergone major surgery (craniotomy, thoracotomy, or laparotomy, and other surgeries according to Investigators' opinion, excluding needle biopsy) within 4 weeks prior to the first dose of the investigational product, or are expected to undergo major surgery during the study, or have severe unhealed wounds, ulcers, etc.;\n8. Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (ie, no neurologic syndrome and metastases ≤1.5 cm in diameter) or stable disease after treatment as judged by the investigator may be considered if: they have no metastases in the midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord; stable status for at least 4 weeks prior to the first dose of study drug (≤1.5 mg\u002Fday dexamethasone or equivalent and baseline anticonvulsants are allowed), and have no new or enlarging CNS metastases as clearly demonstrated by clinical evidence; Note : CNS lesions are not considered target lesions.\n9. Uncontrolled disease or condition, including:\n\n   1. Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals prior to the first dose of the study drug;\n   2. With known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1\u002F2 Ab positive), for participants outside mainland China, participants with positive HIV antibody test at screening are eligible to participate in the study under the premise of undetectable viral load, or well-controlled under antiretroviral therapy (defined as CD4+ T cell count ≥ 350 cells\u002FμL and no history of AIDS-defining opportunistic infection within 12 months before the first dose);\n   3. Acute or chronic active hepatitis B (HBsAg positive and\u002For HBcAb positive, and HBV DNA titer ≥ 10 4 copies\u002FmL or ≥ 2000 IU\u002FmL) or hepatitis C (HCV Ab positive, and HCV RNA \\> 10 3 copies\u002FmL or above the lower limit of detection);\n   4. Active tuberculosis infection, or still receiving anti-tuberculosis treatment, or receiving anti-tuberculosis treatment within 1 year before the first dose of the study drug;\n   5. Uncontrolled myocarditis or symptomatic congestive heart failure Class II-IV (New York Heart Association ,NYHA), symptomatic or uncontrolled arrhythmia, QTc interval \\> 480 ms, or personal or family history of congenital long\u002Fshort QT syndrome;\n   6. Uncontrolled hypertension with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg measured on 2 follow-up visits despite adequate standard treatment;\n   7. Current gastrointestinal tract (muscle-derived tube from the oral cavity to the anus, including oral cavity, pharynx, esophagus, stomach, duodenum, jejunum, ileum, cecum, appendix, colon, rectum, and anus) or endotracheal stent implantation;\n   8. Significant malnutrition, such as malnutrition requiring parenteral nutrition;\n   9. Spinal cord compression that has not been radically cured by surgery and\u002For radiotherapy;\n   10. Ascites, pleural effusion, or pericardial effusion that is symptomatic and requires intervention prior to the first dose of study intervention (participants who do not require treatment or who recover steadily without intervention are eligible).\n10. With a history of pneumonia requiring corticosteroid treatment, or a history of clinically significant lung diseases (such as interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases such as pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury), or suspected of having these diseases by imaging during the screening period;\n11. Any history of arterial thromboembolic events within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular stroke, or transient ischemic attack;\n12. Esophageal or gastric varices requiring immediate intervention (e.g., ligature or sclerotherapy) or at high risk of bleeding according to the opinion of the investigator or a gastroenterologist or hepatologist. Participants with evidence of portal hypertension (including imaging findings of hypersplenism) or a history of esophageal and gastric variceal bleeding must undergo endoscopic evaluation within 3 months prior to the first dose of the study drug;\n13. Any history of life-threatening hemorrhage or hemorrhage requiring blood transfusion, endoscopy, or surgery within 3 months prior to the first dose of the investigational product ;\n14. Unhealed gastrointestinal obstruction, perforation, or fistula. At risk of gastrointestinal obstruction or perforation (including but not limited to: acute diverticulitis, abdominal abscess, etc.), history of extensive bowel resection (segmental colectomy or extensive bowel resection accompanied with chronic diarrhea), active inflammatory bowel disease, or Grade ≥ 2 chronic diarrhea;\n15. History of immunodeficiency diseases, including congenital or acquired immunodeficiency diseases;\n16. History of allogeneic organ transplantation or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation within 3 months prior to the first dose of the investigational drug, except for corneal transplantation;\n17. History of other malignancy within 2 years before the first dose of study drug(s), with the following exceptions:\n\n    1. Malignancy (other than in situ) treated with curative therapy with no known active disease present for ≥ 2 years prior to the first dose of study drug and at low risk of recurrence according to the physician's opinion;\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of residual or recurrent disease;\n    3. Adequately treated carcinoma in situ without evidence of residual or recurrent disease;\n    4. Prostate intraepithelial neoplasia without evidence of prostate cancer;\n    5. Adequately treated urothelial papillary non-invasive carcinoma.\n18. Presence of any indwelling tubes or drains (such as percutaneous nephrostomy tubes, indwelling Foley catheters, biliary drainage tubes, or peritoneal\u002Fpericardial catheters); Note: Thoracic catheters or dedicated central venous access catheters such as Port-A-Cath or Hickman catheters are allowed.\n19. Other acute or chronic diseases or laboratory abnormalities, which may increase the risk of participating in the study or receiving the investigational product, interfere with the interpretation of study results, and make the participant unsuitable for participating in the study based on the investigator's judgment;\n20. Neurological, mental, or social conditions that affect the compliance with trial requirements, significantly increase the risk of AEs, or affect the participants' signing of written informed consent (IC);\n21. Females who are pregnant, have a positive pregnancy test result, or are breastfeeding;\n22. Not fit to participate in this study at the discretion of the Investigator.",{"count":505,"type":22},493,[100],"This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors",[509,238,239,32,510],"Solid Tumor","Head and Neck Squamous Cell Carcinoma","2026-07-21",{"date":490,"type":51},{"date":514,"type":51},"2026-03-31",{"date":516,"type":22},"2028-06-30",{"name":518,"class":58},"Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":535,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":547},"100526215","phase-1-a-study-of-sgn-ceacam5c-in-adults-with-advanced-solid-tumors-100526215","NCT06131840","A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors","An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Tumor type:\n\n   * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.\n\n     * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).\n     * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.\n   * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.\n\n     * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.\n     * PDAC with one or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.\n     * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.\n     * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1\u002FPD-L1 inhibitor. In addition, participants with tumor genomic mutations\u002Falterations for which approved targeted therapies are available per local standard of care, must have received such therapies.\n     * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1\u002FPD-L1 inhibitor.\n   * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.\n   * CRC participants in Part D and Part E (5FU\u002FLV + bevacizumab and 5FU\u002FLV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU\u002FLV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.\n\n   \\> 2L PDAC participants in Part E (5FU\u002FLV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n\n   \\> 1L PDAC participants in Part E (5FU\u002FLV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant\u002Fneoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant\u002Fneoadjuvant chemotherapy are eligible.\n2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and\u002For submission of archival tissue:\n\n   * Monotherapy dose optimization (Part B)\n   * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts\n3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.\n\nExclusion Criteria:\n\n1. Previous exposure to CEACAM5-targeted therapy.\n2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).\n3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Active cerebral\u002Fmeningeal disease related to the underlying malignancy. Participants with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral\u002Fmeningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).\n\n   \\> Criteria related to bevacizumab administration (participants in Parts D and E)\n5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.\n6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.\n8. Deep venous thromboembolic event within 4 weeks prior to enrollment\n9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.\n10. History of any life-threatening VEGF-related adverse event",{"count":527,"type":22},914,[100],"This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.\n\nParticipants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs.\n\nThis clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.\n\nThis study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body.\n\nThis study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.",[155,531,532,32,533,534],"Carcinoma, Non-Small-Cell Lung","Stomach Neoplasms","Gastroesophageal Junction Adenocarcinoma","Small Cell Lung Carcinoma",[303,185,30,536,537,538,539],"GC","GEJ","SCLC","Seattle Genetics",{"date":488,"type":51},{"date":542,"type":51},"2023-11-20",{"date":544,"type":22},"2030-09-12",{"name":546,"class":58},"Seagen, a wholly owned subsidiary of Pfizer",48,{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":555,"sex":18,"minAge":19,"maxAge":556,"enrollmentInfo":557,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":571},"100436960","pancreatic-cancer-early-detection-consortium-100436960","NCT04970056","Pancreatic Cancer Early Detection Consortium","PRECEDE","Inclusion Criteria:\n\nIndividuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:\n\nCohort 1\n\nIndividuals without history of PDAC meeting any of the following criteria:\n\n1. 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.\n2. 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family\n3. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family\n4. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+\n5. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+\n6. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+\n\nCohort 2\n\nIndividuals without history of PDAC meeting any of the following criteria:\n\n1. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+\n2. 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family\n3. 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member\n\nCohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)\n\nCohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.\n\nCohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and\u002For buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.\n\nCohort 6a\n\nIndividuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:\n\n1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other\n2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11\n\nCohort 6b\n\nIndividuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:\n\n1. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other\n2. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11\n3. Diagnosed ≤ age 45\n\nCohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.\n\nCohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.\n\nCyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)\n\nExclusion Criteria:\n\n* Individuals not meeting the criteria above.",true,"90 Years",{"count":558,"type":22},20000,"The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and\u002For individuals carrying pathogenic\u002Flikely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.",[561,562,32,563],"Pancreas Cancer","Pancreas Cyst","Genetic Predisposition",{"date":488,"type":51},{"date":566,"type":51},"2020-09-18",{"date":568,"type":22},"2030-12-31",{"name":570,"class":88},"Arbor Research Collaborative for Health",60,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":555,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":582,"conditions":583,"keywords":594,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":607},"100545979","pancreatic-cancer-detection-consortium-100545979","NCT06388967","Pancreatic Cancer Detection Consortium","Early Detection of Pancreatic Cancer: Prospective Study","PCDC","Inclusion Criteria:\n\n* Histological diagnosis of pancreatic ductal adenocarcinoma, stages I-IV (TNM classification, 8th edition)\n* Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.\n* Imaging- or endoscopy-based proof of lack of pancreatic ductal adenocarcinoma at the time of sampling (Non-disease controls)\n\nExclusion Criteria:\n\n* Lack of written informed consent.",{"count":581,"type":22},2000,"This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.",[28,584,35,32,585,586,587,588,589,590,591,592,593],"Pancreatic Carcinoma","Pancreatic Neoplasms","Pancreatic Cancer Stage I","Pancreatic Cancer Stage","Pancreatic Cancer Resectable","Pancreatic Cancer Stage 0","Pancreatic Cancer Stage II","Pancreatic Cancer Stage III","Pancreatic Cancer, Adult","Pancreatic Cancer Non-resectable",[595,74,596,597,598],"Micro RNA","Cell free","Early detection","Screening","2026-07-15",{"date":601,"type":51},"2026-07-16",{"date":603,"type":51},"2023-03-15",{"date":605,"type":22},"2030-12-30",{"name":87,"class":88},11,{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":555,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":23,"phases":617,"briefSummary":618,"conditions":619,"keywords":624,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":197},"100500670","phase-1-safety-of-rad301-in-healthy-human-volunteers-and-patients-with-pancreatic-cancer-or-other-solid-tumors-100500670","NCT05799274","Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors","Characterizing the Radiochemical and Radiation Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Ductal Adenocarcinoma or Other Solid Tumors","RAD301","Inclusion Criteria:\n\n1. Must be ≥ 18 years of age at the time of informed consent.\n2. All participants must be willing and able to give informed consent.\n3. For patients with cancer: have a history of histologically or cytologically confirmed PDAC, non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma, cervical cancer, endometrial cancer, or ovarian cancer and have had a SOC CT or MRI within 12 weeks prior to giving consent that indicates the presence of at least 1 site of new or residual disease. If the SOC CT or MRI has occurred prior to 12 weeks, consultation with the Sponsor must be sought prior to patient enrollment. SOC images must be available for submission to the centralized imaging reader as reference.\n4. Screening laboratory values within 30 days prior to administration of the study drug:\n\n   1. WBC ≥ 1200\u002FμL\n   2. ANC ≥ 1000\u002FμL\n   3. Platelets ≥ 75,000\u002FμL\n   4. Hemoglobin ≥ 9.0 g\u002FdL\n   5. Creatinine ≤ 1.5 mg\u002FdL\n   6. AST\u002FALT ≤ 3 x ULN for patients with no liver metastases.\n   7. AST\u002FALT ≤ 5 x ULN for patients with liver metastases.\n   8. Bilirubin ≤ 1.5 mg\u002FdL except for participants with Gilbert's disease.\n5. Patients should have a life expectancy of ≥ 12 weeks as judged by the Investigator.\n6. All participants must have baseline pulse oximetry ≥ 95% on room air.\n7. Unremarkable ECGs, with PR intervals of less than 200 msec and QTcF intervals (corrected with Frederica's method) of less than 450 msec.\n8. Willing to refrain from taking illicit drugs one week prior to PET scanning and through the follow-up phone call on Day 3 (+2 days).\n9. Willing to refrain from donating blood for 4 weeks after administration of RAD301.\n10. Have not participated in any other research study that requires taking medication within 4 weeks (or 10 half-lives, whichever is shorter) from the time of informed consent to the end of the Imaging and Safety Follow-Up Period. Previous or ongoing participation in another study should be discussed with the Sponsor.\n\nExclusion Criteria:\n\n1. Participant may not be a member of a vulnerable population defined as participants who are not able to understand the nature of the trial and provide informed consent or who have any medical, psychological or sociological condition that in the opinion of the investigator would interfere with the ability to give consent or interfere with protocol compliance.\n2. Women may not be pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to administration of RAD301.\n3. History of an anaphylactic reaction to a protein- or peptide-derived therapeutic or a diagnostic agent.\n4. History, physical examination, or clinical laboratory tests suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination of RAD301, including chronic liver or renal failure.\n5. Unable to tolerate the study procedures.\n6. Patients with brain metastases are eligible as long as there is no requirement for high doses of systemic corticosteroids that could result in immunosuppression (\\>10 mg\u002Fday prednisone equivalents) for at least 2 weeks prior to study drug administration. An MRI is not required to rule out brain metastases or leptomeningeal metastases\n7. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results.\n8. Clinically significant cardiovascular\u002F cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attach (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \\>II) or serious cardiac arrhythmia.\n9. Other than the tumor types being studied, a prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.\n10. Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n11. Participants who underwent major surgery within 4 weeks of administration of study drug (not including diagnostic laparoscopy).",{"count":253,"type":22},[100],"This is a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in healthy human volunteers and individuals with PDAC or Other Solid Tumors",[620,32,621,622,623,322,321],"Healthy Volunteers","Non-small Cell Lung Cancer (NSCLC)","Esophageal Squamous Cell Carcinoma","Cervical Cancer",[32,625,626,627,628,629],"non-small cell lung cancer (NSCLC)","esophageal squamous cell carcinoma","cervical cancer","endometrial cancer","ovarian cancer",{"date":631,"type":51},"2026-07-17",{"date":633,"type":51},"2023-11-09",{"date":635,"type":22},"2026-08",{"name":637,"class":58},"Radiopharm Theranostics, Ltd",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":23,"phases":646,"briefSummary":647,"conditions":648,"keywords":649,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":224},"100594835","phase-1-a-study-of-asp2138-given-before-surgery-then-chemotherapy-after-surgery-in-people-with-pancreatic-ductal-cancer-100594835","NCT07024615","A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer","A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression","Inclusion Criteria:\n\n* Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional multi-disciplinary review. Participant with localized pancreatic adenocarcinoma cannot have received any prior therapy.\n* Participant has confirmation of positive claudin (CLDN)18.2 test result by local laboratory prior to first dose of study intervention (ASP2138 dosing may be allowed after discussion with the medical monitor, if results are pending or a biopsy for CLDN18.2 testing is not clinically appropriate). Site should contact the sponsor to assess potential eligibility based on a local test result.\n* Participant has an available pretreatment tumor sample, if clinically appropriate and meets requirements.\n* Participant is able to undergo surgery and treatment with adjuvant chemotherapy per institutional standard of care.\n* Participant with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function of class 2B or better using the New York Heart Association Functional Classification.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy package insert \\[PI\\]\u002Fprescribing information, whichever is longer).\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (6 months) after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Female participant must not donate ova starting at first administration of neoadjuvant ASP2138, throughout the investigational period, and for 6 months after final ASP2138 administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Male participant must not donate sperm during the treatment period and for 6 months after ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI\u002Fprescribing information, whichever is longer).\n* Participant has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to the first dose of study intervention per investigator assessment.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has a corrected QT interval by Fridericia (QTcF) ≤ 470 msec.\n* Participant must meet all of the criteria based on laboratory tests within 7 days prior to the first dose of study intervention. Participant has adequate organ and marrow function. If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.\n* Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.\n* Participant has uncontrolled serious psychiatric illness or social situations that would preclude study compliance.\n* Participant has another malignancy for which treatment is required.\n* Participant has a history or complication of interstitial lung disease.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. NOTE: Applicable if participant is receiving fluoropyrimidine containing chemotherapy. Screening for DPD deficiency should be conducted per local requirements.\n* Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with full dose warfarin (coumadin) is not allowed.\n\n  * Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).\n* Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade ≥ 2 bleeding events in the month prior to treatment).\n* Participant has uncontrolled intercurrent illness or infection.\n* Participant is known to have human immunodeficiency virus (HIV) infection. However, participants with cluster of differentiation (CD) 4+ T cell counts ≥ 350 cells\u002FµL and no history of acquired immunodeficiency syndrome (AIDS) defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for HIV infection should be conducted per local requirements.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[hBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted per local requirements.\n\n  * For participant who is negative for hBsAg, but hepatitis B core (HBc) Ab positive, an HBV DNA test will be performed and if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has a known history of UGT1A1 gene polymorphism resulting in complete loss of function of the UGT1A1 gene product (for participants receiving irinotecan containing chemotherapy).\n* Participant has any pre-existing severe gastric conditions such as active gastritis or ulcer that could be exacerbated by treatment.\n* Participant has received any prior chemotherapy, radiation therapy, immunotherapy, or biologic (\"targeted\") therapy or investigational therapy for treatment of the participant's pancreatic tumor.\n* Participant has received a live vaccine within 30 days of planned start of study therapy. NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed.\n* Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.\n* Participant has had a major surgical procedure 28 days before start of study intervention and has not fully recovered.",{"count":7,"type":22},[100],"Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell \"tells\" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery.\n\nIn this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine.\n\nPeople will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.",[32],[650,651,652,653],"Claudin (CLDN) 18.2","ASP2138","Safety","Tolerability","2026-07-14",{"date":599,"type":51},{"date":657,"type":51},"2025-10-16",{"date":659,"type":22},"2028-01-31",{"name":661,"class":58},"Astellas Pharma Global Development, Inc.",{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":23,"phases":671,"briefSummary":666,"conditions":672,"keywords":674,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":686},"100645104","phase-1-a-study-of-gfh276-combined-with-cetuximab-or-chemotherapy-in-participants-with-solid-tumors-and-pancreatic-ductal-adenocarcinoma-pdac-harboring-ras-mutation-100645104","NCT07678593","A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","A Multi-center, Open-label Phase Ib\u002FII Study Exploring the Safety\u002FTolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification\n3. At least one measurable lesion according to RECIST v1.1\n4. ECOG performance status 0 or 1\n5. Life expectancy \\> 3 months\n6. Adequate organ function\n7. Willing to provide written informed consent\n8. Fertile participants must use effective contraception\n\nExclusion Criteria:\n\n1. Other active malignancy within 3 years\n2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor\n3. History of active clinically significant cardiovascular dysfunction\n4. For participants with known concomitant second oncodriver for PDAC or for solid tumors.\n5. With active infection (HIV, HBV, HCV, syphilis)\n6. The presence of clinical or radiological evidence of intestinal obstruction.\n7. Prior anticancer therapy within 28 days or 5 half-lives\n8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months\n9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.\n10. History of central nervous system (CNS)disease\n11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.\n12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.",{"count":670,"type":22},222,[100,124],[673,32,407],"Advanced Solid Tumors Cancer",[675,30,407,676],"GFH276","solid tumors","2026-07-09",{"date":679,"type":51},"2026-07-10",{"date":681,"type":22},"2026-09",{"date":683,"type":22},"2028-09",{"name":685,"class":58},"Genfleet Therapeutics (Shanghai) Inc.",17,{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":4,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":694,"targetDuration":4,"studyType":23,"phases":696,"briefSummary":697,"conditions":698,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":703,"completionDateStruct":704,"leadSponsor":706,"locationsCount":607},"100476358","phase-1-spevatamig-pt886-as-monotherapy-or-in-combination-with-chemo-andor-ici-for-the-treatment-of-patients-with-advanced-gastric-gastroesophageal-junction-pancreatic-ductal-or-biliary-tract-carcinomas-the-twinpeak-study-100476358","NCT05482893","Spevatamig (PT886) as Monotherapy or in Combination With Chemo and\u002For ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)","A Phase 1\u002F2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and\u002For an Immune ChecKpoint Inhibitor. The TWINPEAK Study","Key Inclusion Criteria\n\n1. 18 years or older and able to sign informed consent and comply with the protocol.\n2. Measurable disease as defined by RECIST V1.1 criteria for solid tumors.\n3. 3\\. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated.\n\n   Part C, substudy C1: 2L m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible.\n\n   Part C, substudy C2: 1L m\u002Fa PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).\n\n   Part C, substudy C3: 1L m\u002Fa PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX\u002FmFFX.\n\n   Part C, substudy C4: Patients with m\u002Fa BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment.\n\n   Part D, substudy D3: 2L or 3L m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).\n\n   Part D, substudy D4: 1L HER2 negative m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).\n4. Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function confirmed at screening and within 72 hours of initiating treatment.\n\nKey Exclusion Criteria\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Women who are pregnant or lactating.\n2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.\n3. Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents.\n\nAdditional inclusion and exclusion criteria will apply.",{"count":695,"type":22},258,[100,124],"This is a first-in-human, Phase 1\u002F2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig (PT886). Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, biliary tract carcinoma (BTC) and pancreatic ductal adenocarcinoma (PDAC).",[699,32,700],"Gastric or Gastroesophageal Junction Adenocarcinoma","Biliary Tract Cancer (BTC)","2026-07-07",{"date":677,"type":51},{"date":603,"type":51},{"date":705,"type":22},"2028-04",{"name":707,"class":58},"Phanes Therapeutics",{"id":709,"slug":710,"hasResults":12,"nctId":711,"briefTitle":712,"officialTitle":713,"acronym":4,"eligibilityCriteria":714,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":556,"enrollmentInfo":715,"targetDuration":4,"studyType":23,"phases":717,"briefSummary":718,"conditions":719,"keywords":722,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":734,"lastUpdatePostDateStruct":735,"startDateStruct":737,"completionDateStruct":739,"leadSponsor":741,"locationsCount":607},"100570708","phase-1-lead-212-psv359-therapy-for-patients-with-solid-tumors-100570708","NCT06710756","Lead-212 PSV359 Therapy for Patients With Solid Tumors","A Phase I\u002FIIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients With Solid Tumors That Are Known to be Fibroblast Activation Protein (FAP)-Positive","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Satisfactory organ function as determined by laboratory testing\n* Eastern Cooperative Oncology Group performance (ECOG) status of 0 to 1\n* Life expectancy \\> 3 months\n* Progressive disease despite standard therapy or for whom no standard therapy exists\n* Positive \\[203Pb\\]Pb-PSV359 SPECT\u002FCT scan showing uptake of \\[203Pb\\]Pb-PSV359 in at least 1 known lesion on the 1-hour SPECT\u002F CT scan\n* Histological, pathological, and\u002For cytological confirmation of solid tumor malignancy that is locally advanced or metastatic\n\nExclusion Criteria:\n\n* Known hypersensitivity to the active agent or any of the excipients\n* Active secondary malignancy\n* Pregnancy or breastfeeding a child\n* Known brain metastases\n* Known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to enrollment\n* Known medical condition which would make this protocol unreasonably hazardous for the patient\n* Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions\n* Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the investigational product or excipients\n* Major surgery within 21 days prior to the administration of \\[212Pb\\]Pb-PSV359; the subject must be sufficiently recovered and stable before treatment administration\n* Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to enrollment into the study\n* Current abuse of alcohol or illicit drugs\n* Treatment with any live\u002Fattenuated vaccine in the 7 days prior to enrollment\n* Previous treatment with any systemic anticancer therapy within 4 weeks prior to treatment on study",{"count":716,"type":22},112,[100,124],"Phase I\u002FIIa image-guided, alpha-particle therapy study of \\[203Pb\\]Pb-PSV359 and \\[212Pb\\]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive.",[32,240,242,238,321,243,720,721],"Sarcoma","Mesothelioma",[723,724,435,725,177,726,727,728,729,730,731,732,733],"Fibroblast Activation Protein","Solid tumor malignancy","Esophageal cancer","Ovarian cancer","Head and neck cancer","Theronostic","Radiopharmaceutical","Radiotherapy","Alpha Particle","Pb-203","Pb-212","2026-07-02",{"date":736,"type":51},"2026-07-06",{"date":738,"type":51},"2025-04-28",{"date":740,"type":22},"2032-05-28",{"name":742,"class":58},"Perspective Therapeutics",{"id":744,"slug":745,"hasResults":12,"nctId":746,"briefTitle":747,"officialTitle":748,"acronym":4,"eligibilityCriteria":749,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":750,"targetDuration":4,"studyType":23,"phases":752,"briefSummary":753,"conditions":754,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":755,"lastUpdatePostDateStruct":756,"startDateStruct":758,"completionDateStruct":760,"leadSponsor":762,"locationsCount":333},"100549007","phase-1-a-clinical-study-of-mk-2870-alone-or-with-other-treatments-to-treat-gastrointestinal-cancers-mk-9999-02a-100549007","NCT06428409","A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)","A Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has one of the following cancers:\n\n  * Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer\n  * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer\n  * Advanced and\u002For unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer\n  * Advanced and\u002For unresectable BTC and has not received prior therapy for the cancer\n* For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of severe eye disease\n* For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening",{"count":751,"type":22},220,[100,124],"Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:\n\n* About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it\n* How many people have the cancer respond (get smaller or go away) to treatment",[238,32,244],"2026-06-30",{"date":757,"type":51},"2026-07-01",{"date":759,"type":51},"2024-06-20",{"date":761,"type":22},"2029-10-16",{"name":763,"class":58},"Merck Sharp & Dohme LLC"]