[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-adenocarcinoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-adenocarcinoma-metastatic":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,56,86,117,138,161,189,213,242,307,327,353,377,407,434],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100630728","phase-3-study-of-daraxonrasib-and-daraxonrasib--gnp-as-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100630728",false,"NCT07491445","Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma","RASolute 303","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.\n* Documented RAS mutation status, either mutant or wild-type.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.","ALL","18 Years",{"count":20,"type":21},900,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.",[27,28,29,30,31,32,33,34],"Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenocarcinoma","Pancreatic Adenosquamous Carcinoma",[27,29,36,37,38,39,40,41,42,28,32,34,33],"Pancreatic Ductal Adenocarcinoma","RAS","KRAS","NRAS","HRAS","RAS Wild-Type","RAS Mutation","RECRUITING","2026-06-24",{"date":46,"type":47},"2026-06-25","ACTUAL",{"date":49,"type":47},"2026-03-09",{"date":51,"type":21},"2029-03",{"name":53,"class":54},"Revolution Medicines, Inc.","INDUSTRY",13,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100644113","phase-1-samuraciclib-in-combination-with-gemcitabinenab-paclitaxel-in-patients-with-metastatic-basal-like-pancreatic-cancer-100644113","NCT07665684","Samuraciclib in Combination With Gemcitabine\u002FNab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer","Phase Ib\u002FII Study of Samuraciclib in Combination With Gemcitabine\u002FNab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer","SONIC","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of screening.\n2. Written informed consent and any locally required authorization (eg, data privacy) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening.\n4. Must have life expectancy ≥ 12 weeks at the time of screening.\n5. Histologically or cytologically confirmed PDAC: Eligible histological variants include: mucinous adenocarcinoma, independent cell adenocarcinoma, adenosquamous carcinoma, adenocarcinoma not otherwise specified (NOS).\n6. Dose Escalation: All patients with metastatic PDAC will be permitted to enrol.\n7. Dose Expansion: Patients with metastatic basal-like PDAC will be permitted to enrol, based on the PurIST assay or by transcriptomic sequencing. Patients will be permitted to start no more than one cycle of gemcitabine\u002Fnab-paclitaxel while waiting for transcriptional subtype results in the dose expansion cohort.\n8. Radiographic evidence of metastatic disease that is measurable per RECIST 1.1.\n9. Adequate organ and marrow function within 28 days prior to dosing on Day 1.\n10. Adequate liver function (AST ≤2.5 times the institutional upper limit of normal, total bilirubin ≤2 times the institutional upper limit of normal) at the baseline visit. Patients are permitted to enroll with biliary obstruction, as long as they undergo appropriate biliary decompression (can be done at the same time as endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB)) and hepatic parameters have improved at time of baseline visit.\n11. Patients must have either de novo metastatic disease or recurrence \\>6 months after completion of neoadjuvant or adjuvant intent systemic therapy.\n12. Patients must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments at the time of enrollment (excluding neuropathy which can be ≤ Grade 2, and alopecia)\n13. Patients must be able to take oral medications.\n14. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening to 180 days after the final dose of study treatment. It is strongly recommended for the male partner of a female patient to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n15. Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment. It is strongly recommended for the female partner of a male patient to also use a highly effective method of contraception throughout this period. In addition, male patients must refrain from sperm donation while on study and for 180 days after the final dose of study treatment.\n\nExclusion Criteria:\n\n1. Participants receiving any other study agents concurrently with the study drugs.\n2. Known homologous recombination deficient pancreatic cancer, including germline or somatic BRCA1\u002F2 or PALB2 mutations\n3. Concurrent enrolment in another therapeutic clinical study. Enrolment in observational or supportive care studies will be allowed.\n4. History of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator.\n5. Patients with a history of Grade 3 or greater thromboembolic events in the prior 3 months to the scheduled first dose of study treatment or thromboembolic event of any grade with ongoing symptoms.\n6. Patients with prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment.\n7. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n8. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n9. Other invasive malignancy within 2 years. Non-invasive malignancies (ie, cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition. Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of study treatment and of low potential risk for recurrence are permitted.\n10. Known allergy or hypersensitivity to investigational product formulations.\n11. Active grade 3 or greater edema (eg, peripheral, pulmonary).\n12. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n13. Participants with known untreated brain metastases are excluded. Patients with a history of brain metastases are permitted to enroll if they have been treated and have been stable for a minimum of one month on imaging. Participants must be off all corticosteroids at the time of enrolment.\n14. Major surgery (as defined by the investigator) within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery. Local procedures (eg, placement of a systemic port, core needle biopsy, etc) are allowed, without needing to wait for the 28 day recovery period.\n15. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study.\n16. Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of patient safety or study results.",{"count":65,"type":21},67,[67,68],"PHASE1","PHASE2","The purpose of this study is to find the highest dose of a drug, samuraciclib, that can be given with standard of care chemotherapy (gemcitabine and nab-paclitaxel) without causing very severe side effects. This is done by starting at a dose lower than the one that is used when samuraciclib is taken by itself without chemotherapy. The main question it aims to answer is:\n\n• For patients with newly diagnosed metastatic pancreatic cancer, what is the safety and tolerability of samuraciclib with gemcitabine\u002Fnab-paclitaxel?\n\nParticipants will:\n\n* Undergo a tumor biopsy.\n* Be treated with samuraciclib in combination with their standard of care chemotherapy (gemcitabine\u002Fnab-paclitaxel).\n* Donate research blood samples.",[71,72,32,73,74],"Pancreas Ductal Adenocarcinoma","Pancreas Cancer, Metastatic","Adenosquamous Carcinoma of the Pancreas","Mucinous Adenocarcinoma","NOT_YET_RECRUITING","2026-06-18",{"date":44,"type":47},{"date":79,"type":21},"2026-07",{"date":81,"type":21},"2030-05",{"name":83,"class":84},"University Health Network, Toronto","OTHER",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100636166","phase-3-atebimetinib--gnp-as-a-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100636166","NCT07562152","Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)","MAPKeeper 301","Inclusion Criteria:\n\n* Must be ≥18 years of age\n* Must have confirmed diagnosis according to AJCC staging as follows:\n\n  * Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants must be treatment naive as follows:\n\n  * First-line PDAC participants will have received no previous systemic anti-cancer therapy\n* Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria\n* Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values\n\nExclusion Criteria:\n\n* Inability to swallow oral medications\n* Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma\n* Participants with only locally advanced disease\n* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases",{"count":95,"type":21},510,[24],"The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.",[27,28,29,30,36,32,31,33],[100,101,102,103,104,105,106,107],"mitogen-activated protein kinase (MAPK)","MAPK","MEK","metastatic cancer","gemcitabine","nab-paclitaxel","nab-p","atebimetinib",{"date":109,"type":47},"2026-06-22",{"date":111,"type":21},"2026-06",{"date":113,"type":21},"2029-02",{"name":115,"class":54},"Immuneering Corporation",19,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":126,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":85},"100644194","metabolic-reprogramming-and-microenvironment-in-pancreatic-adenocarcinoma-100644194","NCT07664891","Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma","Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma: Identification of New Therapeutic Targets","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Signed written informed consent specific to the PROMETAP study\n3. Affiliation with a social security system\n4. Treatment and follow-up performed at the Institut Paoli-Calmettes\n5. Metastatic PDAC requiring biopsy as part of routine care (group1 and 2)\n6. Prior treatment:\n\n   * No previous chemotherapy for the \"initial\" group\n   * No prior chemotherapy in the metastatic setting for the \"Metastatic Relapse\" group\n7. Eligible for chemotherapy (ECOG \\\u003C 2)\n\nNon-Inclusion Criteria:\n\n1. Contraindication to biopsy of the pancreatic tumor or a hepatic or pulmonary metastasis (group 1 and 2)\n2. Absence of a metastasis accessible to biopsy (group1 and 2)\n3. Concurrent treatment for another active cancer\n4. Pregnant or breastfeeding women\n5. Patients in emergency situations\n\n5\\. Adult individuals under legal protection (guardianship, trusteeship, judicial protection) or unable to provide informed consent",{"count":125,"type":21},64,"6 Months","OBSERVATIONAL","The present project aims to elucidate the metabolic interactions within the tumor microenvironment of pancreatic adenocarcinoma, both in the primary tumor and in hepatic and pulmonary metastatic sites, as well as in circulating blood biomarkers.\n\nDeciphering these complex interactions aims to identify exploitable vulnerabilities for predicting treatment efficacy or for guiding therapeutic strategies.",[32],"2026-06-17",{"date":44,"type":47},{"date":133,"type":47},"2025-09-11",{"date":135,"type":21},"2028-09-01",{"name":137,"class":84},"Institut Paoli-Calmettes",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100641682","phase-3-study-of-zoldonrasib--chemo-of-investigators-choice-vs-placebo--chemo-of-investigators-choice-as-first-line-treatment-in-metastatic-kras-g12d-mutated-pancreatic-adenocarcinoma--rasolute-305--100641682","NCT07621718","Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )","RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma","RASolute 305","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to screening.\n* Documented KRAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.\n* Prior systemic RAS-targeted therapy any time prior to randomization.\n* Presence of other known driver mutations with approved targeted therapies\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":147,"type":21},670,[24],"The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.",[27,28,29,30,31,32,33,34],[27,29,36,37,38,42,28,32,34,33],"2026-06-12",{"date":154,"type":47},"2026-06-16",{"date":156,"type":47},"2026-05-22",{"date":158,"type":21},"2030-04-22",{"name":53,"class":54},3,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":188,"locationsCount":4},"100637017","expanded-access-program-for-daraxonrasib-rmc-6236-in-previously-treated-metastatic-pancreatic-adenocarcinoma-100637017","NCT07573215","Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma","Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Daraxonrasib","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed PDAC with metastatic disease.\n* Evidence of active disease progression during or following the most recent line of systemic therapy for PDAC, based on investigator assessment.\n* At least one prior line of systemic therapy in the metastatic setting, which must include either a fluoropyrimidine-based or gemcitabine-based regimen.\n* Received and progressed, been intolerant to prior standard therapy, or no longer expected to benefit from standard therapies.\n* Adequate bone marrow, renal, hepatic, and coagulation functions.\n* Ineligible for, or unable to enroll in, another clinical trial of daraxonrasib, if available.\n* Able to take oral medications\n\nExclusion Criteria:\n\n* History of known central nervous system metastatic disease.\n* Concurrent systemic anticancer therapy.\n* Significant cardiovascular disease.\n* Major GI conditions that may affect the ability to take or absorb daraxonrasib (patients with prior Whipple procedure are eligible).\n* Active uncontrolled systemic infection.\n* Major surgery within 28 days before enrollment.\n* Additional inclusion and exclusion criteria may apply.","EXPANDED_ACCESS","This Expanded Access Program (EAP) is intended to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.",[29,30,171,27,28,32,33,34],"Metastatic Pancreas Adenocarcinoma",[173,174,175,176,177,178,179,180,181,182,37,38,28,32,34,33,183],"Expanded Access Program (EAP)","EAP","Daraxonrasib","RMC-6236","RMC-0706236","Metastatic pancreatic adenocarcinoma","Pancreatic ductal adenocarcinoma (PDAC)","RAS(ON) inhibitor","Unmet medical need","Pancreatic cancer","Compassionate Use","AVAILABLE","2026-05-01",{"date":187,"type":47},"2026-05-07",{"name":53,"class":54},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":211,"locationsCount":85},"100636531","phase-1-a-phase-i-study-to-evaluate-the-safety-and-efficacy-of-l19il2-in-combination-with-ruxolitinib-in-patients-with-advanced-solid-tumors-100636531","NCT07566897","A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of one of the following tumor types for which no further approved systemic treatment options are available:\n\n   1. Unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, that has progressed following:\n\n      * at least one prior line containing FOLFIRINOX and\u002For gemcitabine plus nab-paclitaxel, and\n      * at least one approved second-line regimen (e.g., 5-FU\u002Fleucovorin plus liposomal irinotecan), or where these regimens are not suitable due to contraindication or prior intolerance\n   2. Metastatic proficient mismatch repair \u002F microsatellite stable (pMMR\u002FMSS), BRAF V600E-negative colorectal adenocarcinoma, that has progressed following:\n\n      * at least one prior line of systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan, with or without anti-VEGF and, if RAS wild-type, with or without anti-EGFR, and\n      * at least one approved subsequent line of therapy with trifluridine-tipiracil, regorafenib or fruquintinib, or where these agents are not suitable due to contraindication or prior intolerance;\n   3. Metastatic clear cell renal cell carcinoma, that has progressed following:\n\n      * at least one prior PD-(L)1-based systemic regimen, and\n      * at least one VEGF-targeted tyrosine kinase inhibitor (TKI), or where these treatments are not suitable due to contraindication or prior intolerance\n2. Patients must have no further approved and available therapy options or be documented as ineligible or intolerant.\n3. Patients must have radiographic disease progression on\u002Fafter the last line of prior treatment.\n4. At least one unidimensionally measurable lesion as defined by RECIST v.1.1.\n5. Eastern cooperative oncology group (ECOG) performance status ≤ 2.\n6. Patient has an estimated life expectancy of at least 12 weeks.\n7. Hemoglobin \\> 10.0 g\u002FdL.\n8. Platelets ≥ 100 x 109\u002FL.\n9. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL.\n10. Negative TB test (e.g., Mantoux or Quantiferon assay).\n11. Documented negative test for HIV, HBV, HCV excluding active infection is needed. For HBV serology: the determination of HBsAg and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and\u002For anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n12. Serum creatinine \\\u003C 1.5 x ULN and estimated Glomerular Filtration Rate (eGFR) value above 75 mL\u002Fmin\u002F1.73m2. An age-calibrated definition of Chronic Kidney Disease (CKD) has been proposed to distinguish age-related from disease-related changes in eGFR. For patients younger than 40 years, CKD is defined by estimated Glomerular Filtration Rate (eGFR) below 75 mL\u002Fmin\u002F1.73m2.\n13. All acute toxic effects (excluding alopecia) of any prior therapy must have been resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.5.0) Grade ≤ 1.\n14. Women Of Childbearing Potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to six months following the last study treatment administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner. Double-barrier contraception is required.\n15. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to six months following the last study treatment administration. Double-barrier contraception is required.\n16. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Patients with primary brain tumors, brain metastases or CNS disease will be excluded.\n2. Chemotherapy, immunotherapy, or radiation therapy at the tumor sites within 4 weeks prior to study treatment start.\n3. Active or history of autoimmune disease that might deteriorate when receiving an immunostimulatory agent.\n4. Previous or concurrent cancer type that is distinct from the cancer being evaluated in this study. Exception made for any other cancer curatively treated ≥ 2 years prior to study treatment start.\n5. Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n6. Impaired cardiocirculatory functions due to any of the following conditions:\n\n   a History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.\n\n   b Inadequately controlled cardiac arrhythmias including atrial fibrillation. c Heart insufficiency (\\> Grade II, New York Heart Association (NYHA) criteria). d Any abnormalities observed during baseline ECG and Echocardiogram investigations are considered clinically significant by the investigator.\n\n   e Uncontrolled hypertension defined by systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg.\n\n   f Ischemic peripheral vascular disease (Grade IIb-IV).\n7. Known arterial aneurysms.\n8. INR \\> 3.\n9. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). At the discretion of the investigator, an increased exclusion threshold for patients with liver metastasis can be accepted as follows: ALT, AST and ALP ≥ 5 x ULN.\n10. Known uncontrolled coagulopathy or bleeding disorder, if the subject is being treated for coagulopathy or bleeding disorder and has tests within screening limits, he\u002Fshe may be included.\n11. Known hepatic cirrhosis or severe pre-existing hepatic impairment (Child-Pugh class B or C).\n12. Moderate to severe respiratory failure.\n13. Patient requires or is taking systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n14. Known history of allergy to an excipient in study medication (e.g. IL2, ruxolitinib) or other human proteins\u002Fpeptides\u002Fantibodies.\n15. Pregnancy or breast-feeding.\n16. Severe diabetic retinopathy.\n17. Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n18. Patient with iatrogenic or pathologic severe immune suppression.\n19. Requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n20. Patient taking herbal medications within 7 days prior to study treatment start.\n21. Anticoagulation therapy with P2Y12 antagonists (e.g., clopidogrel, ticagrelor) and vitamin K antagonists (e.g., phenprocoumon, warfarin).","75 Years",{"count":197,"type":21},96,[67],"This trial aims to address unmet medical needs in advanced solid tumors, specifically metastatic clear cell renal carcinoma, locally advanced or metastatic pancreatic adenocarcinoma, and metastatic colorectal adenocarcinoma.",[201,32,33,202],"Renal Carcinoma Metastatic","Metastatic Colorectal Carcinoma (mCRC)",[204,205],"Ruxolitinib","Advanced solid tumors","2026-04-28",{"date":208,"type":47},"2026-05-05",{"date":185,"type":21},{"date":81,"type":21},{"name":212,"class":54},"Philogen S.p.A.",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100563412","predictive-value-of-transcriptome-based-oncotreatoncotarget-and-organoid-testing-in-metastatic-pancreatic-cancer-100563412","NCT06615830","Predictive Value of Transcriptome-based OncoTreat\u002FOncotarget and Organoid Testing in Metastatic Pancreatic Cancer.","HIPANC-002 - Observational Performance Study of Transcriptome-Based OncoTreat\u002FOncoTarget Testing With Patient-Derived Organoids in Metastatic Pancreatic Cancer","Inclusion criteria:\n\n* Informed Consent as documented by signature\n* Patients older than 18 years\n* Patients with metastatic pancreatic ductal adenocarcinoma\n* At least one lesion amenable for surgical excisional biopsy\n* ECOG Performance status 0-2\n* Radiologically measurable disease\n* Life expectancy \\> 3 months\n* Absolute leucocyte count \\>1.5 G\u002Fl, platelets \\>100 G\u002Fl\n* Serum creatinine \\\u003C1.5 times of the upper limit of normal or Clearance \\>50ml\u002Fmin (according to the CKD-EPI formula)\n\nExclusion criteria:\n\n* Known allergies or intolerance to one or more compounds present in one of the first line or second line regimens\n* Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy\n* ECOG PS \\>2\n* Heart failure (NYHA class III-IV)\n* Severe or uncontrolled concurrent illness\n* Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment\n* Myocardial infarction within the previous 6 months\n* Patients who are pregnant or breastfeeding",{"count":221,"type":21},185,"Pancreatic cancer is burdened by a survival of barely 10% at 5 years. About 80% of new cases do not qualify for surgery due to either locally-advanced or metastatic disease. In patients with good performance status (PS), palliative first-line treatments mainly consist of combination regimens, such as FOLFIRINOX, modified FOLFIRINOX or Gemcitabine-Abraxane. For subjects with a poor PS, instead, guidelines recommend single-agent infusions (e.g. Gemcitabine, Capecitabine or 5-FU alone). Nevertheless, upon disease progression therapeutic options are still scarce and with limited sustained efficacy.\n\nOverall survival in metastatic pancreatic cancer ranges between 9.1 and 13.5 months, while progression-free survival under either FOLFIRINOX or Gemcitabine-Abraxane spans between 5.5 and 6.4 months. This timespan reduces even further when standard second-line regimens must be initiated upon disease progression.\n\nNowadays, genomic and transcriptomic analysis are crucial tools in cancer research that enable the identification of genetic mutations and alterations that drive the development and progression of cancer. By studying the changes in the DNA and RNA sequences of cancer cells, researchers can gain insights into the underlying molecular mechanisms of cancer and identify potential therapeutic targets. Genomic analysis can identify specific mutations or alterations that are present in cancer cells, while transcriptomic analysis can reveal changes in gene expression that may be linked to disease progression or response to treatment. These analyses are an essential component for the development of precision medicine approaches, which aim to tailor cancer treatment to the individual genetic profile of each patient.\n\nPDOs can replicate in vitro the biological, genetic and molecular aspects of the primary tumour. Some of their advantages include their rapid growth compared to xenografts, the possibility to perform high-throughput drug screening, and their direct application to precision oncology by predicting best therapies. In this study they will be used as an in vitro comparator of the molecular tests to the clinical course of the patient.\n\nOverall, combining genomic and transcriptomic analysis with PDO technology in cancer research might lead to exponential capacity to provide oncologic patients with extremely tailored and effective cancer treatments in the future.\n\nFor HIPANC-002 these tests are being evaluated as non-interventional investigational IVD's. Test results are not to be used for protocol mandated therapy decisions.",[224,225,28,32],"Pancreas Neoplasms","Pancreatic Neoplasms",[182,227,178,228,229,230,231,232],"Pancreatic adenocarcinoma","Organoid","Organoid-driven chemotherapy","Darwin Oncotreat","Darwin Oncotarget","Personalized chemotherapy","2026-02-07",{"date":235,"type":47},"2026-02-11",{"date":237,"type":21},"2026-06-01",{"date":239,"type":21},"2031-01",{"name":241,"class":84},"Prof. Dr. med. Dres. h.c. Jan Schmidt, MME",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":271,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100374021","phase-1-sharon-a-clinical-trial-for-metastatic-cancer-using-chemotherapy-and-patients-own-stem-cells-100374021","NCT04150042","SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells","SHARON: Study of Metastatic Cancers in Patients Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives","SHARON","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Pancreatic or breast cancer, as described below.\n* Stage IV (based on AJCC staging guidelines) at the time of enrollment.\n\n  a. Note that potential subjects with stage IV cancer that have had a complete response from prior chemotherapy are still potentially eligible.\n* Expected survival time ≥ 6 months, as determined by the investigator.\n* Life expectancy not severely limited by diseases other than malignancy, as determined by the investigator.\n* Karnofsky score ≥ 60%.\n* No chemotherapy within 2 weeks of enrollment.\n* Prior surgical resection or ablation of the primary tumor is allowed but not required.\n* If post-surgical, the subject must be at least 28 days post-op with the surgical wounds healed and significant complications resolved.\n* Potential subjects who have received previous chemotherapy and\u002For PARP inhibitors may be enrolled.\n* Measurable or non-measurable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1.\n* For potential subjects with a germline BRCA1, BRCA2, or PALB2 mutation:\n\n  a. The mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n* For potential subjects with somatic BRCA1, BRCA2, or PALB2 mutations:\n\n  1. The mutation must be a known or suspected deleterious mutation as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n  2. There must be biallelic loss or inactivation of the mutated BRCA1, BRCA2, or PALB2 gene as assessed by a CLIA-certified laboratory.\n  3. The Genetics Review Committee for this trial, which is comprised of a core group of investigators and whose actions are performed in accordance with the committee's charter, must agree that the biallelic mutations are deleterious or suspected deleterious.\n* For subjects without a BRCA1, BRCA2, or PALB2 mutation\n\n  1. Subject must have received at least 16 weeks of first-line (platinum-based\\*) chemotherapy with no evidence of treatment failure, where treatment failure is defined as growing tumors, new lesions, or a steadily rising tumor marker during or within eight weeks of completion of the first line therapy.\n  2. \\* Subjects can also have been treated with FOLFIRINOX but switched to FOLFIRI due to oxaliplatin side effects.\n* For potential subjects with pancreatic cancer:\n\n  1. Pancreatic ductal adenocarcinoma or pancreatic acinar cell carcinoma.\n  2. If the potential subject has had surgical resection of the primary tumor, then there must be no evidence of disease progression between the time of surgical resection of the primary tumor and screening for enrollment if the patient is seeking enrollment in the immediate post-surgery period.\n* For potential subjects with breast cancer:\n\n  1. Adenocarcinoma of the breast.\n  2. HER2-negative cancer as per American Society of Clinical Oncology\u002FCollege of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines.\n  3. Male or female sex.\n* Histological or cytological confirmation of the primary cancer diagnosis is required.\n* Metastatic disease must be histologically or cytologically confirmed unless in the clinical judgment of the investigator a biopsy is not needed for diagnostic purposes.\n* Female participants of childbearing potential must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n  1. Simultaneously practice two effective barrier methods of contraception. Oral and injectable contraceptives are not allowed. Barrier methods of birth control (e.g., diaphragm and spermicide, or condom and spermicide) are required.\n  2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n* Male participants:\n\n  1. Unless the male is in a monogamous relationship with a female that does not have child-bearing potential, male subjects (even if surgically sterilized) must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n     1. Practice effective barrier contraception, plus a second method of effective contraception.\n     2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n\nExclusion Criteria\n\n* Rapid disease progression or clinical features concerning for onset of rapid symptomatic deterioration, as determined by the investigator.\n* Biliary tract obstruction.\n* Current cholangitis. A biliary stent in situ does not otherwise exclude protocol participation.\n* A history of only one episode of cholangitis and fewer than 30 days have passed since discontinuation of antibiotic treatment.\n* A history of multiple episodes of cholangitis and after discussion between the site study team and sponsor medical monitor and careful evaluation for suitability the patient is deemed to be unsuitable for the trial due to risk of recurring cholangitis.\n* Portal hypertension.\n* Sinistral portal hypertension.\n* Obliteration or significant obstruction of the major veins or arteries (e.g., portal vein, superior mesenteric artery, superior mesenteric vein).\n* Clinically significant malignant ascites or malignant pleural effusion, as determined by the investigator.\n* Metastatic lesion to the heart or eye.\n* Chemotherapy for an indication other than treatment of the current cancer within the past 1 year with a more than 30% risk of recurrence as determined by the investigator.\n* Known or suspected metastatic involvement of the central nervous system.\n* Left ventricular ejection fraction less than 45% by Multigated Acquisition Scan or echocardiogram (or significantly below the lower limit of normal for the specific test).\n* Clinically significant structural heart disease or vascular disease.\n* Myocardial infarction within 6 months prior to enrollment; New York Heart Association (NYHA) Class III or IV heart failure; angina; uncontrolled ventricular arrhythmias; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n* Clinically significant prolongation of QTc (Bazett formula) on EKG, defined as \\> 0.45 s in males and \\> 0.47 s in females.\n* Severe hypertension, which is defined as the presence of any of the following:\n\n  1. History of hypertensive crisis, hypertensive emergency, or malignant hypertension within the last year.\n  2. Sustained or persistent systolic BP \\> 165 mm Hg or diastolic \\> 110 mm Hg.\n* Other clinically significant cardiovascular disease.\n* NOTE:\n\n  1. A past history of severe hypertension that is well-controlled with therapy or that was addressed by removal of the cause (e.g., removal of a medicine that caused the severe hypertension) is not an exclusion criterion.\n  2. The presence of a pacemaker is not a contraindication and is not considered an exclusion criterion\n* History or evidence of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis).\n* If a smoker, refusal to stop smoking for the duration of the trial.\n* FEV1 or DLCO (adjusted for hemoglobin) \\\u003C 50% of predicted.\n* Total bilirubin \\> 2x upper normal limit, except that potential subjects with Gilbert's Disease are permitted to exceed 2x upper normal limit.\n* ALT or AST \\> 2.5x upper normal limit.\n* Alkaline phosphatase \\> 2.5x upper normal limit, in conjunction with elevated GGT.\n* Albumin \\\u003C 3.0 g\u002Fdl.\n* Clinical evidence of sinusoidal obstruction syndrome.\n* Corrected creatinine clearance consistently \\\u003C 50 ml\u002Fmin\u002F1.73 m\\^2.\n* Clinically significant renal disease.\n* Hemolytic anemia.\n* Family history of catalase deficiency or history or evidence of a severe adverse reaction to hydrogen peroxide consistent with catalase deficiency, unless testing has demonstrated that the patient is not catalase-deficient.\n* Evidence of bone marrow insufficiency or failure, in the judgment of the investigator.\n* A hemoglobin \\\u003C 9 g\u002FdL.\n* G6PD deficiency as measured by quantitative enzyme levels below the normal reference range in blood.\n* Pre-existing bleeding diathesis or coagulopathy.\n* Potential subject is pregnant.\n* Breast feeding and unwilling to stop.\n* Wilson's disease.\n* Primary or secondary hemochromatosis.\n* Hgb A1c \\> 9%.\n* Hyperuricemia that is not responsive to therapy.\n* Plasma oxalate greater than 10 µM, which is not responsive to measures to reduce the level below 10 µM.\n* History of clinically significant elevation of plasma oxalic acid or complications related to oxalic acid.\n* Prior or current hepatitis B or C.\n* HIV infection or seropositivity for HIV.\n* Active, clinically significant bacterial, viral, or fungal infection.\n* History of colonization with a multidrug-resistant \"superbug\" that poses a high risk of an untreatable infection in the setting of neutropenia.\n* Uncontrolled seizure disorder.\n* If a potential subject has received radiation, then any of the following:\n\n  1. A volume ≥ 700 ml of normal liver received a dose ≥ 10 Gy.\n  2. The mean dose to normal liver (i.e., liver minus gross tumor volume) was ≥ 10 Gy.\n  3. The mean dose to normal lung (i.e., lung minus gross tumor volume) was ≥ 4 Gy.\n* History of significant allergy or other contraindication to BCNU, melphalan, vitamin B12b, vitamin C, pegfilgrastim, or Neupogen, or to any excipient in those drugs.\n* Use of any of the following cytochrome P450 2b6 (CYP2b6) inducers within 21 days of the planned date of BCNU treatment: phenobarbital, carbamazepam, rifampicin, phenytoin, sulfinpyrazone, or verapamil.\n* Disulfiram (Antabuse) use within 30 days of the planned ethanol administration.\n* Current chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids).\n* Prior bone marrow stem cell transplant.\n* Except for adjuvant therapy for breast cancer or pancreatic cancer, prior radiation therapy to the brain, kidneys, pelvis, or GI tract or treatment with yttrium-90.\n* Prior treatment with bleomycin or BCNU.\n* Prior treatment, within 30 days of enrollment, with a drug that has not been FDA-approved for any indication (cancer or otherwise).\n* Subject has not fully recovered (i.e., there remain toxicities \\> Grade 1) from the reversible effects of prior chemotherapy, with the exception of chemotherapy-induced alopecia and grade 2 peripheral neuropathy, unless in the opinion of the principal investigator the effects are not of clinical significance.\n* Any concurrent anticancer treatment.\n* Serious underlying medical or psychiatric illness or another condition that in the clinical judgment of the principal investigator is likely to interfere with the potential subject completing participation in the trial, based on safety concerns or otherwise.\n* Inability or unwillingness to adhere to the study protocol.\n* Unwillingness to receive ethanol.",{"count":251,"type":21},24,[67],"The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.",[32,255,256,257,36,27,258,259,260,261,262,263,264,265,266,72,267,268,269,270],"BRCA1 Mutation","BRCA2 Mutation","Pancreatic Acinar Cell Carcinoma","Metastatic Pancreatic Cancer","Metastatic Pancreatic Ductal Adenocarcinoma","Breast Cancer Metastatic","Breast Cancer Stage IV","Pancreatic Cancer Stage IV","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","Adenocarcinoma of the Breast","PALB2 Gene Mutation","Pancreas Cancer, Recurrent","Pancreas Cancer","Stage IV Pancreatic Cancer","Stage 4 Pancreatic Cancer",[272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,29,287,288,289,290,291,292,293,294,295,296],"pancreatic adenocarcinoma","pancreatic cancer","BRCA","BRCA1","BRCA2","melphalan","BCNU","carmustine","vitamin C","vitamin B12b","autologous stem cell infusion","stage 4 pancreatic cancer","metastatic pancreatic cancer","pancreatic acinar cell carcinoma","pancreatic ductal adenocarcinoma","breast cancer","stage 4 breast cancer","stage IV pancreatic cancer","stage IV breast cancer","stem cells","HER2-negative breast cancer","PALB2","metastatic breast cancer","BRCA pancreatic cancer","BRCA breast cancer","2026-01-27",{"date":299,"type":47},"2026-01-29",{"date":301,"type":47},"2021-01-13",{"date":303,"type":21},"2028-12",{"name":305,"class":54},"General Oncology, Inc.",2,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":326},"100621932","phase-1-clinical-trial-of-omtx705-in-combination-with-gemcitabinenab-paclitaxel-and-tislelizumab-in-patients-with-advancedmetastatic-pancreatic-adenocarcinoma-100621932","NCT07377045","Clinical Trial of OMTX705 in Combination With Gemcitabine\u002FNab-Paclitaxel and Tislelizumab in Patients With Advanced\u002FMetastatic Pancreatic Adenocarcinoma","Phase 1b Dose Escalation Trial of OMTX705, an Anti-Fibroblast Activation Protein Antibody-Drug Conjugate, in Combination With Gemcitabine\u002FNab-Paclitaxel and Tislelizumab in Patients With Advanced\u002FMetastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n1. Capable of giving signed informed consent.\n2. Male and female participant aged 18 years and older.\n3. Participants must have histologically or cytologically confirmed PDAC: a) Metastatic PDAC who have not received therapy or received 1 prior line of systemic cytotoxic therapy (Part 1 and Part 2) and if trial treatment is given in the second line setting; b) Non-resectable locoregional PDAC who have not received therapy or received 1 prior line of systemic cytotoxic therapy (Part 1 only); c) A previous treatment with a targeted agent (for example KRAS inhibitor in the context of a clinical trial) without chemotherapy not counted as previous line of therapy. This situation should be discussed with the medical monitor.\n4. Participants should have documented disease progression if previously locally advanced disease or be in 2nd line for stage IV or, in the opinion of the investigator, despite of lack of documented PD per image, require a change in the therapy.\n5. Participants should be considered in general eligible for standard GA, for first or second line for metastatic disease (Part 1 and 2) or as palliative therapy for non-resectable locoregional cancer (Part 1 only). Patients who received polychemotherapy (FOLFIRINOX or similar) as neoadjuvant\u002Fadjuvant treatment and recur locally or distant \\\u003C6 months after the completion of systemic therapy, will be classified as second line.\n6. Measurable disease by RECIST v1.1 on CT PET\u002FCT or magnetic resonance imaging (MRI) scan.\n7. Eastern Cooperative Group Performance (ECOG) performance status 0-1.\n8. Adequate bone marrow, hepatic and renal function: a) Total bilirubin ≤1.5 times upper limit of normal (ULN) or total bilirubin n \\\u003C3.0 × ULN with direct bilirubin within normal range in participants with documented Gilbert's syndrome; b) AST and ALT ≤3 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed); c) Serum creatinine ≤1.5 x ULN or creatinine clearance ≥40 mL\u002Fmin (measured or calculated using the Cockroft-Gault formula); d) Hemoglobin ≥9.0 g\u002FdL (whole or partial blood transfusions not allowed in the two previous weeks); e) ANC ≥1.5 x 109\u002FL (growth factors like granulocyte-colony stimulating factor are not allowed in the two previous weeks); f) Platelet count ≥100 x 109\u002FL (platelet in the two previous weeks transfusions not allowed).\n9. Women of childbearing potential (WOCBP) and men with sexual partners who are WOCBP must be willing to adhere to highly effective contraceptive requirements and must agree to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 90 days after the last dose of any IMP. Men with sexual partners who are WOCBP should adhere to contraception requirements for 180 days after the last dose of any IMP.\n10. Suitable venous access for safe drug administration and the study-required drug concentration and pharmacodynamics sampling.\n11. A valid archival tumor sample.\n12. Pretreatment fresh biopsy is optional in Part 1 dose escalation. In Part 2, a fresh pretreatment biopsy and on-treatment is required unless biopsy is associated with significant risk and per discussion with the sponsor medical monitor (or designee).\n\nExclusion Criteria:\n\n1. Prior treatment with OMTX705 or nab-paclitaxel for the locally advanced (adjuvant or neoadjuvant) for metastatic disease. Previous use of gemcitabine as radiosensitizer or as part of neoadjuvant\u002Fadjuvant therapy is allowed if the treatment was completed 6 months before consent signature. Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies including anti-cytotoxic T-lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1 therapeutic antibodies or any immune checkpoint inhibitor (except for participants to be enrolled in Part 1A).\n2. Treatment with systemic anticancer treatments, investigational products, or major surgery within 4 weeks before the first dose of study drug or 5 half-lives, whichever is shorter. Participants should have recovered from previous treatment toxicity to Grade 1, baseline (excluding anemia, lymphopenia, alopecia, and skin pigmentation). Participants with endocrinopathies should have the replacement treatment in stable dosing.\n3. History of uncontrolled brain metastasis. Participants with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have brain imaging during screening confirming that brain metastasis are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT and considered controlled with ≤10 mg\u002Fday prednisone equivalent at the time of receiving the first dose of OMTX705). For asymptomatic participants, screening brain imaging is not required.\n4. Participant has received extended field radiotherapy ≤4 weeks before the start of treatment (≤1 week for limited field radiation for palliation), and who has not recovered to Grade 1 or better from related side effects of such therapy (except for alopecia).\n5. Major surgical procedure or significant traumatic injury ≤21 days prior to ICF signature.\n6. Cardiac arrhythmias requiring anti-arrhythmic therapy. Note: pacemakers, beta blockers, or digoxin are permitted.\n7. Active infection requiring parenteral or oral antibiotics. Antibiotics given for prophylaxis are allowed. They are also allowed for minor localized infections like cystitis, amygdalates or localized skin infections.\n8. Evidence of serious uncontrolled medical disorder that, in the opinion of the investigator or medical monitor, makes it unwise for the participant to participate in the study or that might jeopardize compliance with the protocol.\n9. Drainage of ascitic or pleural fluid two or more times in the four weeks prior to the first dose of study drug or permanent drain in place (e.g., PleurX®) for ascites or pleural effusion symptom management.\n10. Placement of a biliary stent, endoscopic retrograde cholangiopancreatography (ERCP) or biliary catheterization (internal or percutaneous) procedure \\\u003C7 days before the first dose.\n11. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.\n12. Previous or concurrent cancer that is distinct in primary site or histology from PDAC within 3 years prior to randomization except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta \\[non-invasive tumor\\], Tis \\[carcinoma in situ\\] and T1 \\[tumor invades lamina propria\\]); note: all cancer treatments for cancers that were distinct in a primary site other than PDAC must be completed at least 3 years prior to signature date of the ICF.\n13. Uncontrolled or significant cardiovascular disease defined by the New York Hearth Association classification III or IV.\n14. History of cerebrovascular stroke or myocardial infarction within the previous 3 months.\n15. Grade ≥2 peripheral neuropathy.\n16. Received a live vaccine within 30 days prior to first dose of study drug.\n17. Known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants who have positive hepatitis B surface antigen antibody can be included but must have an undetectable hepatitis B viral load. Participants receiving antiviral therapy for hepatitis B virus for any reason are excluded.\n18. Participants positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive participants must meet the following criteria: a) have CD4+ T-cell (CD4+) counts ≥350 cells\u002FμL; b) have not had an opportunistic infection within the past 12 months. Participants on prophylactic antimicrobials can be included in the trial; c) should be on established antiretroviral therapy for at least four weeks; d) have an HIV viral load of less than 400 copies\u002FmL prior to enrollment; e) known history of any other relevant congenital or acquired immunodeficiency other than HIV infection.\n19. Known or suspected allergy to study treatment or related products, and specifically participants with a prior history of life-threatening reaction to polysorbate 20.\n20. Women who are pregnant or breastfeeding or trying to become pregnant.\n21. Male participants wishing fathering children, planning for future sperm banking, or expressing concerns about sterility.\n22. Participants requiring the concomitant administration of medications that are strong inhibitors or inducers of CYP3A4, 2D6, 1A2, 2C9, 2B6, and 2C19. In case they are taking any of these drugs, they should be stopped at least 14 days prior to first dose.\n23. Except Part1A: History of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses \\>10 mg\u002Fday).\n24. Except Part 1A: Participants who discontinued prior treatment with any immune checkpoint due to irAEs, irrespective of grade, recovery, or need for continued steroid therapy. Also, participants without formal contraindication due to previous irAE are not eligible if the AE has not resolved to Grade 1 or better and\u002For still requires steroids (\\>10 mg of prednisone equivalent per day) for ongoing management.\n25. Except Part 1A: participants with a history of pneumonitis\u002Finterstitial lung disease, and participants who discontinued prior immune checkpoint inhibitors due to Grade 2 myocarditis.",{"count":315,"type":21},69,[67],"This is a Phase 1b dose escalation trial of OMTX705, an anti-fibroblast activation protein (FAP) antibody-drug conjugate (ADC), in combination with gemcitabine\u002Fnab-paclitaxel and tislelizumab in patients with advanced\u002Fmetastatic pancreatic ductal adenocarcinoma (PDAC).\n\nThe trial will be conducted in two parts (Part 1 and Part 2). Both parts will enroll participants with advanced PDAC that, in general, are eligible to receive gemcitabine\u002Fnab-paclitaxel. Part 1 is intended to determine the safe recommended dose of OMTX705 in combination with gemcitabine\u002Fnab-paclitaxel (1A) and in combination with gemcitabine\u002Fnab-paclitaxel+tislelizumab (1B). Both 1A and 1B will enroll in a standard 3+3 design. Only one dose level of OMTX705 will be selected for Part 2 by a Data Safety Monitoring Board (DSMB). In Part 2, 3 parallel randomized arms will be opened simultaneously with 1:1:1 randomization (N=15 each): OMTX705+gemcitabine\u002Fnab-paclitaxel (arm 2A), OMTX705+tislelizumab+gemcitabine\u002Fnab-paclitaxel (arm 2B) and gemcitabine\u002Fnab-paclitaxel (arm 2C, reference arm).",[32],"2026-01-21",{"date":299,"type":47},{"date":322,"type":47},"2025-10-28",{"date":51,"type":21},{"name":325,"class":54},"Oncomatryx Biopharma S.L.",7,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":85},"100617112","phase-1-nh002-mediated-sonoporation-with-chemotherapy-in-advanced-pancreatic-cancer-100617112","NCT07314385","NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer","A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis","Inclusion Criteria:\n\n1. Dated and signed informed consent\n2. Either sex, aged 18 to 80 years old (inclusive) at the date of consent\n3. With histologically or cytologically confirmed PDAC\n4. With life expectancy at least 12 weeks\n5. Two or more liver metastatic lesions; of them, at least one lesion with the longest diameter (measured on computed tomography \\[CT\\] or Magnetic resonance imaging \\[MRI\\]) at least 1 cm and not more than 5 cm as well as a depth not more than 7 cm from the skin to the lesion center, and considered feasible for sonoporation by the investigator\n\n   \\- Note: The number of liver metastatic lesions with the longest diameter at least 1 cm should be no more than 10.\n6. Has failed frontline gemcitabine-based chemotherapy and is prepared for an application of NHI-reimbursed nal-IRI, LV, and 5-FU treatment\n7. Has not received previous radiotherapy, local therapy (e.g., radiofrequency ablation, irreversible electroporation, etc.), or cell therapy (autologous or allogenic) for PDAC\n8. Has recovered from all treatment-related toxicities or resolved to no greater than grade 1, based on common terminology criteria for adverse events (CTCAE) v.5.0, before enrollment\n9. With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n10. With adequate hematology function at screening, defined as:\n\n    * White blood cell (WBC) at least 3,500\u002Fmm3\n    * Absolute neutrophil count (ANC) at least 1,500\u002Fmm3\n    * Hemoglobin at least 10.0 g\u002FdL\n    * Platelet at least 100,000\u002Fmm3\n    * Prothrombin time (PT) not more than 1.5 fold upper limit of normal (ULN)\n    * Activated partial thromboplastin time (aPTT) not more than 1.5 fold ULN\n    * International normalized ratio (INR) of PT not more than 1.5 fold ULN\n11. With adequate hepatic function at screening, defined as:\n\n    * Total bilirubin not more than 2 fold ULN and 2.0 mg\u002FdL\n    * Alanine transaminase (ALT) and aspartate transaminase (AST) not more than 5 fold ULN and 200 U\u002FL\n12. With adequate renal function at screening, defined as:\n\n    * Serum Creatinine not more than 1.2 mg\u002FdL\n    * Creatinine clearance at least 50 mL\u002Fmin (Cockroft-Gault formula)\n13. Women of childbearing potential, including those experiencing chemical menopause or absence of menstruation for medical reasons, must consent to use at least two contraceptive precautions, one of which must be a condom or other adequate barrier method, and refrain from breastfeeding from informed consent until at least 5 months after the final dose of investigational product.\n14. Men must consent to use at least one contraceptive precaution from the initiation of the study treatment until at least 3 months after the final dose of the investigational product\n\nExclusion Criteria:\n\n1. Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days before screening\n2. Presence of diarrhea at least grade 2 based on CTCAE v.5.0\n3. Concomitant systemic infection requiring treatment\n4. Clinically significant co-morbid medical conditions, including cardiovascular disease, such as:\n\n   * Myocardial infarction within 180 days before screening\n   * Uncontrollable angina pectoris within 180 days before screening\n   * New York Heart Association (NYHA) Class III or IV congestive heart failure\n   * Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure at least 150 mmHg or diastolic blood pressure at least 90 mmHg lasting 24 hours or more)\n   * Arrhythmia requiring treatment\n5. Prior organ allograft or allogeneic bone marrow transplantation\n6. Received immunosuppressants within 28 days before screening or have received systemic steroid of equivalent dosage higher than prednisolone 30 mg\u002Fday for more than 7 days within 14 days prior to Cycle 1 Day 1\n7. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome\n8. Moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment\n9. Central nervous system metastasis\n10. Prior or concurrent malignancy other than PDAC within the last 3 years, except for carcinoma in situ of the cervix or basal type skin cancer\n11. Any major surgery within 4 weeks before screening. Patients must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before Cycle 1 Day 1\n12. Pregnant women or nursing mothers, or positive pregnancy tests at screening\n13. Severe mental disorder which may affect the subject s compliance to the study protocol, as judged by the investigator\n14. Prior history of allergy to agents that is similar to IP such as any MB ultrasound contrast agents or IRI or LV or 5-FU\n15. Judged by the principal investigator (PI) or sub-investigators to be inappropriate for participation in this study\n16. Known or suspected hypersensitivity reactions to NH002-related phospholipids or polyethylene glycol (PEG), including prior reactions to common PEG-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)\n17. Known or suspected hypersensitivity reactions to one or more of the ingredients of NH002, Definity, or other perflutren-containing echocardiographic contrast agent.\n18. Clinically unstable cardiopulmonary conditions, including but not limited to obstructive lung disease, cardiac shunt abnormalities, or arteriovenous shunt abnormalities, considered not suitable for participation in the trial, in the judgment of the investigator\n\n    \\-","80 Years",{"count":251,"type":21},[67],"This is a phase I study that will enroll patients with pancreatic cancer and liver metastasis who have failed prior gemcitabine-based chemotherapy. Patients will be treated with nanoliposomal irinotecan plus 5-FU and leucovorin and NH002-based sonoporation to the liver metastasis.",[32,339],"Liver Metastasis",[272,341,342,343],"liver metastasis","sonoporation","nanoliposomal irinotecan","2025-12-17",{"date":346,"type":47},"2026-01-02",{"date":348,"type":21},"2026-01-01",{"date":350,"type":21},"2027-12-31",{"name":352,"class":84},"National Taiwan University Hospital",{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":365,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":376},"100614798","phase-1-ttfields-and-chemotherapy-in-metastatic-pancreatic-adenocarcinoma-mpdac-100614798","NCT07284277","TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)","Phase Ib-II, Non-randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With modFOLFIRINOX for Front-line Treatment of Metastatic Pancreatic Adenocarcinoma (NOVOFFOX)","Inclusion Criteria:\n\nAll the patients should comply with the following criteria for inclusion:\n\n1. Histological\u002Fcytological diagnosis of pancreatic adenocarcinoma.\n2. The patient should be 18 years of age and older.\n3. The patient has given consent to participate in the study.\n4. The patient should be able to comply with all the requirements of the clinical trial.\n5. Life expectancy of at least 3 months.\n6. Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy.\n7. Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n9. Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX.\n10. Prior chemotherapy or radiotherapy on the neoadjuvant or adjuvant setting is allowed as long as at least six months have elapsed since last chemotherapy treatment.\n11. Able to operate the Novo TTF-200T System independently or with the help of a caregiver.\n12. Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1.\n\n    1. WBC higher than or equal to 2.5 x 10\\^9\u002FL.\n    2. ANC higher than or equal to 1.5 x 10\\^9\u002FL without granulocyte colony-stimulating factor support.\n    3. Platelet count higher than or equal to 100 x 10\\^9\u002FL without transfusion.\n    4. Hemoglobin higher than or equal to 9 g\u002FdL. Patients may be transfused to meet this criterion.\n    5. Albumin higher than or equal to 2.5 g\u002FdL.\n    6. Serum bilirubin lower than or equal to 1.5 times the upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value lower than or equal to 3 x ULN.\n    7. INR and aPTT lower than or equal to 1.5 x ULN.\n    8. AST, ALT, lower than or equal to 5 x ULN.\n    9. Serum creatinine lower than or equal to 1.5 x ULN or Creatinine Clearance higher than or equal to 30ml\u002Fmin (calculated using Cockcroft-Gault formula).\n13. For women of childbearing potential: Negative serum pregnancy test within 14 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of lower than or equal to 1 percentage per year during the treatment period (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal o transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable o implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion or vasectomized partner) and for at least 180 days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (higher than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\nExclusion Criteria:\n\nPatients who present any of the following criteria for exclusion cannot be included in the clinical trial:\n\n1. Malignancies other than pancreatic cancer within 3 years prior to Cycle 1 Day 1 (C1D1) with the exceptions of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival higher than 90 percentage), treated with expected curative outcome (such as but not limited to: adequately treated in situ carcinoma of the cervix, basal squamous or melanomatous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).\n2. Previous treatment with chemotherapy for metastatic pancreatic ductal adenocarcinoma.\n3. Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques, must have been completed at least 4 weeks prior to study entry.\n4. Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity.\n5. Previous radiation therapy within 14 days prior to C1D1 and\u002For persistence of radiation-related adverse effects.\n6. Implantable electronic medical devices in the torso, such as pacemakers.\n7. Known severe hypersensitivities to medical adhesives or hydrogel, or history of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study treatments used.\n8. Spinal cord compression not definitively treated with surgery and\u002For radiation.\n9. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n10. Pregnant and lactating women\n11. Patients who have received brivudine, sorivudine or analogues 4 weeks prior to Fluoracile administration.\n12. Serious co-morbidities, including but not limited to:\n\n    1. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second\u002Fthird degree hart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse.\n    2. History of cerebrovascular accident (CVA) within 3 months prior to randomization or that is not stable.\n    3. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.\n    4. History of any psychiatric condition that might impair patient´s ability to understand or comply with the requirements of the study or to provide consent.",{"count":361,"type":21},30,[67,68],"The purpose of this clinical trial is to assess the safety and tolerability of TTFields in combination with chemotherapy in adults with metastatic pancreatic adenocarcinoma based on treatment-emergent adverse events of chemotherapy (modFOLFIRINOX) or device (TTFields).\n\nThe main questions it aims to answer are:\n\n* Is TTFields treatment safe for the patients in combination with modFOLFIRINOX?\n* Are participants compliant with the treatment?\n* Is Is TTFields treatment effective in combination with modFOLFIRINOX against metastatic pancreatic adenocarcinoma?",[32,36],[27,366,33],"Metastatic Pancreatic Adenocarcinoma","2025-12-02",{"date":369,"type":47},"2025-12-16",{"date":371,"type":47},"2025-10-14",{"date":373,"type":21},"2027-03",{"name":375,"class":84},"Clinica Universidad de Navarra, Universidad de Navarra",5,{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":306},"100573558","phase-2-maintenance-niraparib-plus-ipilimumab-in-patients-with-metastatic-pancreatic-adenocarcinoma-whose-disease-has-not-progressed-on-platinum-based-chemotherapy-100573558","NCT06747845","Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy","ParpVax2: A Phase II Study Of Maintenance Niraparib Plus Ipilimumab In Patients With Metastatic Pancreatic Cancer Whose Disease Has Not Progressed On Platinum-Based Therapy","ParpVax2","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease\n* ≥18 years of age\n* Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent\n* Participants must have received 8-12 cycles (4-6 months) of first-line FOLFIRINOX or modified FOLFIRINOX for metastatic disease with stable disease or better. Patients treated with liposomal irinotecan with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) are also eligible. Patients who were initially treated with FOLFIRINOX or NALIRIFOX but stopped oxaliplatin because of toxicity are eligible for the trial.\n\n  * Note: This requires at least stable imaging and a stable or decreasing tumor marker as applicable and as determined by the investigator.\n* Measurable disease is not a requirement for study entry.\n\n  * Note: The study will require that at least 80% of enrolled patients (ie 55 of all patients) are biopsiable at enrollment. The investigators may require measurable\u002Fbiopsiable disease as the study progresses in order to achieve this goal.\n* Participants must be willing to undergo a pre-treatment fresh tumor biopsy (if medically feasible).\n* Participants must be willing to undergo an on-treatment tumor biopsy (if medically feasible).\n* Female participant has a negative serum pregnancy test within 24 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 6 months (females) or 30 days (males) after the last dose of study treatment, or is of nonchildbearing potential.\n* Male patient agrees to use an adequate method of contraception starting with the first dose through 90 days after the last dose of study treatment.\n* Adequate organ function confirmed by the following laboratory values obtained ≤7 days prior to the first day of study therapy:\n\n  * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n  * Platelets\\>100 x 109\u002FL\n  * Hemoglobin ≥9g\u002FdL\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN); if liver metastases, then ≤5 x ULN\n  * Total bilirubin ≤1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert's syndrome, then ≤2.5 x ULN.\n  * Serum creatinine ≤1.5 x ULN or estimated glomerular filtration rate (GFR) ≥45 mL\u002Fmin using Cockcroft Gault formula.\n* Eastern Cooperative Oncology (ECOG) performance status of 0 to 1.\n\nExclusion Criteria:\n\n* Prior treatment with a PARP inhibitor, ipilimumab, or other cytotoxic T-lymphocyte-associated-4 protein (CTLA-4) inhibitor.\n* Patients who have demonstrated resistance to FOLFIRINOX are not eligible to participate in this study\n* Patients with known pathogenic\u002Flikely pathogenic germline or somatic alteration(s) in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.\n* Patients with known mismatch repair deficiency or microsatellite instability-high cancer.\n* Clinical evidence of uncontrolled malabsorption and\u002For any other gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with the absorption of niraparib\n* Patients with uncontrolled hypertension, defined as systolic BP \\>140mmHg and\u002For diastolic BP \\>90mmHg\n* Patients with a prior history of posterior reversible encephalopathy syndrome (PRES)\n* Acute infection requiring intravenous antibiotics, intravenous antiviral or intravenous antifungal agents during the 14 days prior to first dose of study therapy\n* Patients will be excluded if they have a history of or active autoimmune disease, defined as: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic autoimmune disease (e.g. rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis e.g. Wegener's Granulomatosis); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome).\n\n  * Note: Patients are permitted to enroll if they have 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.\n* Has a history of interstitial lung disease or active, non-infectious pneumonitis\n* Has received a live vaccine within 4 weeks prior to the first dose of trial therapy\n\n  * Note: seasonal influenza vaccines for injection are generally inactivated and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed.\n* For fertile patient (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and:\n\n  * Female patients refusing to use effective contraception for 6 months after the last dose of study drug.\n  * Male patients refusing to use effective contraception for 90 days after the last dose of study drug.\n* Received any systemic treatment for pancreatic cancer ≤14 days prior to first dose of therapy. Patients must not have had investigational therapy administered ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.\n* Patients will be excluded if they have a condition requiring systemic treatment with either corticosteroids (\\>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\>10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \\> 4 weeks and was related to the most recent treatment.\n* Non-study related minor surgical procedure ≤5 days, or major surgical procedure ≤21 days, prior to the first dose of therapy; in all cases, patients must be sufficiently recovered and stable before treatment administration.\n* Active drug or alcohol use or dependence that would interfere with study compliance.\n* Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study.\n* Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).\n* Patients must not be simultaneously enrolled in any therapeutic clinical trial\n* Patients must not have had radiotherapy within 4 weeks of the first dose of study treatment\n* Patients must not have a known hypersensitivity to the components of niraparib or the excipients\n* Patients must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks of the first dose of study treatment\n* Patients must not be undergoing treatment for a second active cancer at the time of randomization. Exceptions include: (1) local therapies for skin cancers, (2) hormonal therapies for breast or prostate cancer without evidence of active disease. Patients may have a history of: (1) adequately treated nonmelanoma skin cancers, (2) curatively treated in situ cancer of the cervix, (3) curatively treated DCIS, (4) curatively treated stage I, grade 1 endometrial carcinoma, (5) other solid tumors and lymphomas (without bone marrow involvement) diagnosed at least five years prior to randomization and treated with no evidence of disease recurrence.\n* Patients with active hepatitis B or hepatitis C infections, as defined by positive PCR testing, may not enroll.\n* Patients with HIV may enroll, but must have an undetectable viral load at the time of enrollment and must be receiving a stable regimen of HAART.\n* Patients must not have known, symptomatic brain or leptomeningeal metastases.",{"count":386,"type":21},68,[68],"The main goal of this study is to look at the effectiveness and anti-tumor activity (preventing growth of the tumor) of the drugs niraparib and ipilimumab, on the patients and their pancreatic cancer. This study will involve two different treatment arms. In Arm A, patients will receive niraparib plus ipilimumab. In Arm B, patients will receive standard chemotherapy.\n\nThe main questions the study aims to answer are:\n\n* Does niraparib plus ipilimumab slow down tumor growth in patients with pancreatic cancer?\n* What medical problems do participants have when taking niraparib plus ipilimumab?\n\nParticipants will:\n\n* Undergo screening procedures to evaluate their cancer, overall health, and suitability for the study\n* After passing screening, will be randomized to Arm A or B and be scheduled to receive niraparib plus ipilimumab (Arm A) or chemotherapy (Arm B)\n* Receive niraparib plus ipilimumab every 3 weeks (Arm A)\n* Receive chemotherapy every 2 weeks (Arm B)\n* Visit the clinic for regular checkups and tests",[32],[391,392,393,29,394,395,396,397],"Niraparib","Ipilimumab","Pancreatic ductal adenocarcinoma","Maintenance cancer therapy","Platinum-based therapy","PARP inhibitor","anti-CTLA-4 therapy","2025-09-10",{"date":400,"type":47},"2025-09-16",{"date":402,"type":47},"2025-05-07",{"date":404,"type":21},"2029-01-30",{"name":406,"class":84},"Abramson Cancer Center at Penn Medicine",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":85},"100576987","phase-1-xnw27011-study-of-advanced-solid-tumor-subjects-who-failed-standard-therapies-100576987","NCT06792435","XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.","A Phase I\u002FⅡ, First-in-Human Study of XNW27011 in Patients with Locally Advanced And\u002For Metastatic Solid Tumors","Inclusion Criteria:\n\n* Phase I (Dose Escalation)：\n\n  1. Patients are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.\n  2. Age ≥18 years old when signing the informed consent form.\n  3. Patients with a histologically or cytologically-confirmed, locally advanced or metastatic solid tumor, which has failed on standard therapy or is intolerable to available standard therapy, or there is no available standard therapy for the tumor. The advanced solid tumors include but are not limited to gastric and gastroesophageal junction adenocarcinoma, pancreatic adenocarcinoma, esophageal adenocarcinoma, ovarian cancer, lung cancer, colorectal cancer, andbiliary tract cancer.\n  4. The enrollment is not restricted to patients with tumor expressing CLDN18.2. However patients are required to provide tumor tissue sections for CLDN18.2 expression confirmation.\n  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n  6. Estimated life expectancy \\> 12 weeks.\n  7. At least one measurable cancer lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n  8. Adequate organ function, evidenced by the following laboratory results:\n\n     1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n     2. Platelet count ≥ 100 × 109\u002FL.\n     3. Hemoglobin ≥ 9.0 g\u002FdL.\n     4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).\n     5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN (if liver metastases are present, ≤ 3 × ULN).\n     6. Creatinine clearance (Ccr) ≥60 mL\u002Fminute as calculated using themodified Cockcroft-Gault equation.\n     7. QTc prolongation to ≤480 milliseconds (ms) (based on the average of 3 screening electrocardiograms) (QTc interval corrected by Fridericia's Correction Formula, QTcF = QT\u002F(RR0.33).\n     8. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.\n  9. Female patients of childbearing potential, who are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.\n\n     1. Childbearing potential is defined as any female who has experienced menarche and does not meet the criteria for postmenopausal, which is defined as the past 12 months with no menses without an alternative medical cause or permanently sterilized (e.g., has undergone bilateral tubal occlusion\u002Fligation, hysterectomy, bilateral oophorectomy, bilateral salpingectomy).\n     2. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \\\u003C1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or a vasectomized partner.\n  10. Male patients with female sexual partners of childbearing potential are eligible for inclusion if they agree to use medically acceptable birth control during the study, and for 180 days after the last dose of study medication. Sexual abstinence, vasectomy, or a condom used with a spermicide are medically acceptable birth control methods for males. Male subjects must agree not to donate sperm for a period of 180 days after the last dose of study treatment.\n\nPHASE Ⅱ (DOSE EXTENSION)：\n\n1. Subjects are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.\n2. Age ≥18 years old when signing the informed consent form.\n3. Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, which have failed on standard therapy, or are intolerable to available standard therapy, or for which there is no available standard therapy.\n\n   Patients are grouped by anatomic locations of solid tumors:\n\n   Group A: gastric adenocarcinoma\u002Fgastroesophageal junction adenocarcinoma. Group B: pancreatic adenocarcinoma. Group C: ovarian cancer. Group D: other cancer including esophagus adenocarcinomas, lung cancer, colorectal cancer, and biliary tract cancer.\n4. Only patients with tumor expressing CLDN 18.2 will be enrolled. The most recently available tumor samples of patients will be examined by IHC at a central laboratory. If no archived tumor samples are available or the archived tumor samples are deemed to be inappropriate for the confirmation of CLDN18.2 expression, a new biopsy must be performed to obtain the tumor sample to confirmation of CLDN18.2 expression.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n6. Estimated life expectancy \\> 12 weeks.\n7. At least one measurable cancer lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n8. Adequate organ function, evidenced by the following laboratory results:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n   2. Platelet count ≥ 100 × 109\u002FL.\n   3. Hemoglobin ≥ 9.0 g\u002FdL.\n   4. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5× ULN (if liver metastases are present, ≤ 3 × ULN).\n   6. Creatinine clearance (Ccr) ≥50 mL\u002Fminute as calculated using the modified Cockcroft-Gault equation.\n   7. QTc prolongation to ≤ 480 millisecond (ms) (based on the average of 3 screening electrocardiograms) (QTc interval corrected by Fridericia's Correction Formula, QTcF = QT\u002F(RR0.33).\n   8. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.\n9. Female patients of childbearing potential, who are willing to use a highly effective method of birth control during the study and for at least 180 days following the last dose of study medication.\n\n   1. Childbearing potential is defined as any female who has experienced menarche and does not meet the criteria for postmenopausal, which is defined as the past 12 months with no menses without an alternative medical cause or permanently sterilized (e.g., has undergone bilateral tubal occlusion\u002Fligation, hysterectomy, bilateral oophorectomy, bilateral salpingectomy).\n   2. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \\\u003C1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or a vasectomized partner.\n10. Male patients with female sexual partners of childbearing potential are eligible for inclusion if they agree to use medically acceptable birth control for 180 days following the last dose of study medication. Sexual abstinence, vasectomy, or a condom used with a spermicide are medically acceptable birth control methods for males. Male subjects must agree not to donate sperm for a period of 180 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* PHASE I (DOSE ESCALATION)：\n\n  1. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.\n  2. Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any excipient in the XNW27011 formulation.\n  3. Having any of the following medical conditions in the past or at present:\n\n     1. Acquired or congenital immunodeficiency diseases or organ transplantation.\n     2. Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before the first administration, severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade Ⅲ or IV heart failure, uncontrollable hypertension (Systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg at rest).\n     3. Concomitant diseases that will seriously endanger the safety of the subject or affect the completion of the tests, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, lung fibrosis, kidney failure, and uncontrolled diabetes(HbA1c\\>8%).\n     4. History of or currently suffering from uncontrolled primary or metastasized brain tumors, except that the investigator believes that the disease has been stabilized in patients, or whose local treatment has ended.\n     5. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of the XNW27011.\n     6. Past or current mental illness that is difficult to control.\n     7. Human immunodeficiency virus (HIV) infection, syphilis infection, or active hepatitis B or C infection. Note: Syphilis infection refers to active syphilis or latent syphilis that requires treatment.\n     8. Patients who have active infections that required systemic treatment within 2 weeks prior to the first dose of XNW27011.\n     9. Clinically significant third spacing (large amount of pleural fluid or ascites, judged by treating physician) that is uncontrollable by drainage or other methods.\n     10. Having any adverse event from prior anti-tumor treatments that have not yet recovered to Grade 0 or 1 per NCI-CTCAE v5.0 (except alopecia).\n  4. History of treatment:\n\n     1. Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose of XNW27011.\n     2. Received anti-tumor therapy (chemotherapy, radiotherapy, immunologic therapy or biological therapy,) within 3 weeks, prior to the first dose of XNW27011, or received small molecular targeted therapy, anti-tumor medicinal herb or proprietary Chinese traditional medicines within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks.\n     3. Received major surgical or interventional treatment within 4 weeks prior to the first dose of XNW27011, with the exception of tumor biopsy, puncture, etc.\n     4. Received systemic steroid therapy for a long period of time (≥20 mg of prednisone\u002Fday or equivalent for \\>7 days). (Short-term use of no more than 7 days or steroid therapy withdrawal longer than 2 weeks prior to the first dose of XNW27011 can be selected).\n     5. Received live vaccines within 4 weeks prior to the first dose of XNW27011 or plan to take any live vaccine during the study period.\n     6. Received strong inhibitors or inducers of CYP3A4, or strong inhibitors of CYP2D6 within 2 weeks or five half-lives (whichever is shorter) of the inhibitor or inducer prior to the first dose of XNW27011.\n  5. Women who are pregnant or breastfeeding, or women whose serum pregnancy test results are positive during the screening period (female patients who are infertile do not need to undergo a pregnancy test, e.g., female patients who underwent hysterectomy, bilateral tubal occlusion\u002F ligation, bilateral salpingectomy, or bilateral oophorectomy in the past, or women with resection or amenorrhea ≥12 months).\n  6. Patients who have poor compliance and are not expected to cooperate to complete the study procedures, or who are deemed unsuitable to participate in the clinical research by the investigator. PHASE Ⅱ (DOSE EXTENSION)：\n\n  \u003C!-- -->\n\n  1. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.\n  2. Prior severe allergic reaction or intolerance to the Topoisomerase I Inhibitor or Topoisomerase Inhibitor-Based ADC (e.g: Fam-trastuzumab deruxtecan-nxki, Sacituzumab govitecan-hziy, Irinotecan, Topotecan) or any excipient in the XNW27011 formulation.\n  3. Having any of the following medical conditions in the past or present:\n\n     1. Acquired or congenital immunodeficiency diseases or organ transplantation.\n     2. Past myocardial infarction (within 6 months before the first administration), hospitalization for congestive heart failure within 12 months before the first administration, severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade Ⅲ or IV heart failure, uncontrollable hypertension (Systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg at rest).\n     3. Concomitant diseases that will seriously endanger the safety of the subject or affect the completion of the study, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, lung fibrosis, kidney failure, and uncontrolled diabetes (HbA1c\\>8%).\n     4. Previously or currently suffering from uncontrollable primary or metastasized brain tumors, except that the investigator believes that the disease has been stabilized in patients, or whose local treatment has ended.\n     5. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of XNW27011.\n     6. Past or current mental illness that is difficult to control.\n     7. Human immunodeficiency virus (HIV) infection, syphilis infection, or active hepatitis B or C infection.\n\n        Note: Syphilis infection refers to active syphilis or latent syphilis that requires treatment.\n     8. Patients who have active infections that required systemic treatment within 2 weeks prior to the first dose of XNW27011.\n     9. Has multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors curatively treated.\n     10. Clinically significant third spacing (large amount of pleural fluid or ascites, judged by treating physician) that is uncontrollable by drainage or other methods.\n     11. Having any adverse event from prior anti-tumor treatments that have not yet recovered to Grade 0 or 1 per NCI-CTCAE v5.0 (except alopecia).\n  4. History of treatment:\n\n     1. Patients who have previously been treated with ADCs or CAR-T targeting CLDN18.2, or participated in clinical trials of other drugs within 4 weeks before the first dose of XNW27011.\n     2. Received anti-tumor therapy (chemotherapy, radiotherapy, immunologic therapyor biological therapy) within 3 weeks, prior to the first dose of XNW27011, or received small molecular targeted therapy, anti-tumor medicinal herb or proprietary Chinese traditional medicines within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks.\n     3. Have received major surgical or interventional treatment within 4 weeks prior to the first dose of XNW27011, with the exception for tumor biopsy, puncture, etc.\n     4. Received systemic steroid therapy for a long period of time (≥20 mg of prednisone\u002Fday or equivalent for \\>7 days). (Short-term use of no more than 7 days or steroid therapy withdrawal longer than 2 weeks prior to the first dose of XNW27011 can be selected).\n     5. Received live vaccines within 4 weeks prior to the first dose of XNW27011or planned to take any live vaccine during the study period.\n     6. Received strong inhibitors or inducers of CYP3A4, or strong inhibitors of CYP2D6 within 2 weeks or five half-lives (whichever is shorter) of the inhibitor or inducer prior to the first dose of XNW27011.\n  5. Women who are pregnant or breastfeeding, or women whose serum pregnancy test results are positive during the screening period (female patients who are infertile do not need to undergo a pregnancy test, e.g., female patients who underwent hysterectomy, bilateral tubal occlusion\u002Fligation, bilateral salpingectomy, or bilateral oophorectomy in the past and women with resection or amenorrhea ≥12 months).\n  6. Patients who have poor compliance and are not expected to cooperate to complete the study procedures, or who are deemed unsuitable to participate in the clinical research by the investigator.",{"count":415,"type":21},240,[67,68],"This is a global, multi-center, open-label, Phase I\u002FII first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and\u002For metastatic solid tumors who have failed or are intolerant to standard therapies. XNW27011 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), a transmembrane protein important to tight junctions. The study consists of 2 parts: Part 1 is the dose-escalation phase (Phase I), and Part 2 is the does-expansion phase (Phase II). In phase I part of the study, approximately 42 patients with locally advanced and\u002For metastatic solid tumors will be enrolled, irrespective of CLDN18.2 expression. However, the most recently available tumor tissue specimen will be collected (if available) for a retrospective CLDN18.2 expression confirmation. In phase II part of the study, only patients with confirmed CLDN18.2 expression by IHC in the central laboratory will be enrolled.The phase II part of the study will consist of the following four groups，Up to three dose cohorts for each patient group are planned currently. Each dose cohort will include approximately 20 patients. Approximately 240 patients evaluable will be enrolled in Phase Ⅱ part of the study.",[32,419,420,421,422,423,424],"Lung Cancer (NSCLC)","Ovarian Cancer","Colorectal Cancer Metastatic","Biliary Tract Cancer","Gastric Carcinoma","Gastroesophageal Junction Adenocarcinoma","2025-02-05",{"date":427,"type":47},"2025-02-07",{"date":429,"type":47},"2023-07-27",{"date":431,"type":21},"2025-12-31",{"name":433,"class":54},"Evopoint Biosciences Inc.",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":442,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":85},"100520076","phase-2-penpulimab-combined-with-anlotinib-and-nab-paclitaxel-plus-gemcitabine-as-first-line-treatment-for-advanced-metastatic-pancreatic-cancer-100520076","NCT06051851","Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer","Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine (PAAG) as First-line Treatment for Advanced Metastatic Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Phase 2 Study","RCT-PAAG","Inclusion Criteria:\n\n* Ages ≥18 years，ECOG ≤ 2，Estimated survival time \\> 3 months\n* Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma\n* Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion\n* Patients have never received systematical anti-cancer therapy\n* Laboratory examination meets the following requirements:\n\nWhite blood cell (WBC) ≥3.0×109\u002FL; absolute neutrophil count (ANC) ≥1.5×109\u002FL; Hemoglobin (HB) ≥90g\u002FL; platelet count(PLT) ≥75×109\u002FL; Total bilirubin (TBIL) ≤1.5× normal upper limit (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr)≥50ml\u002Fmin;\n\n* Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) \\> 50%\n* Patients of childbearing age should take appropriate protective measures before enrollment and during the trial\n* Volunteer to join the study, sign the informed consent, have good compliance, and cooperate with follow-up\n* Ability to follow the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\n* Patients have ever received any systematical anti-cancer therapy in the past\n* Patients who participated in other clinical trials in the past 4 weeks\n* According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator)\n* Patients with moderate ascites requiring drainage\n* Patients with CNS metastases and\u002For carcinomatous meningitis\n* Patients with history of other primary malignancies except: 1) complete remission before enrollment for at least 2 years and requiring no additional treatment during the study period; 2) Adequately treated non-melanoma skin cancer or lentiform malignancy with no evidence of disease recurrence; 3) Adequately treated carcinoma in situ with no evidence of disease recurrence;\n* Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs\n* Patients with bleeding tendency.\n* Pregnant or lactating women.\n* Drug abuse, clinical or psychological or social factors that impact informed consent or the conduct of the study\n* Patients who may be allergic to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel and gemcitabine",true,{"count":444,"type":21},177,[68],"This is a multi-center, open-label， randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients with metastatic pancreatic cancer.",[32],[449,450,451,452],"advanced metastatic pancreatic cancer","Chemotherapy","immunotherapy","Targeted Therapy","2023-09-18",{"date":455,"type":47},"2023-09-25",{"date":457,"type":47},"2023-07-01",{"date":459,"type":21},"2026-07-01",{"name":461,"class":84},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"]