[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-adenocarcinoma-advanced-or-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-adenocarcinoma-advanced-or-metastatic":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100574188","phase-1-ct-95-in-advanced-cancers-associated-with-mesothelin-expression-100574188",false,"NCT06756035","CT-95 in Advanced Cancers Associated With Mesothelin Expression","Phase 1a\u002F1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression","Inclusion Criteria:\n\n* ECOG 0 or 1\n* Subjects with evaluable disease per RECIST 1.1 or mRECIST\n* Subjects with adequate organ function.\n* Subjects with advanced cancers associated with mesothelin expression\n\nExclusion Criteria:\n\n* Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study.\n* Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy\n* Concurrent participation in another investigational clinical trial.\n* Evidence of leptomeningeal disease","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1a\u002F1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.",[26,27,28,29,30,31,32,33,34,35,36],"Mesothelin-Expressing Tumors","Epithelial Ovarian Cancer","Malignant Pleural Mesothelioma, Advanced","Malignant Peritoneal Mesothelioma, Advanced","Pancreatic Adenocarcinoma Advanced or Metastatic","Lung Adenocarcinoma Metastatic","Cholangiocarcinoma Advanced","Cholangiocarcinoma Non-resectable","Mesothelin-expressing Advanced Cancers","Mesothelin-positive Advanced Malignant Solid Tumors","Colorectal Cancer",[38,39,40,41,42],"Phase 1 Dose Escalation Study","CT-95","Advanced, recurrent cancers","Unresectable, metastatic cancers","Cancers associated with mesothelin expression","RECRUITING","2026-06-10",{"date":46,"type":47},"2026-06-12","ACTUAL",{"date":49,"type":47},"2025-03-31",{"date":51,"type":20},"2028-12",{"name":53,"class":54},"Context Therapeutics Inc.","INDUSTRY",9,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100642404","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-antitumor-activity-of-inv-8989-in-patients-with-advanced-solid-tumors-harboring-kras-g12d-mutations-100642404","NCT07610798","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations","A Phase I\u002FII, Open-Label, Multi-Center, Dose Escalation and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations","Inclusion Criteria:\n\n1. Written informed consent obtained.\n2. Adult patients aged ≥ 18 years.\n3. Patients with histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumors harboring the KRAS G12D mutations.\n4. Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy.\n5. Have RECIST 1.1-defined measurable lesions.\n6. Has a life expectancy of \\> 3 months.\n7. ECOG performance status 0-1.\n8. Adequate marrow, liver and kidney function.\n9. Meet the study's specified contraceptive requirements.\n10. Meet protocol-specified washout period requirements.\n\nExclusion Criteria:\n\n1. Have protocol-defined toxicities within 28 days before the start of study treatment.\n2. Have a second primary malignancy.\n3. Patients with known hypersensitivity to the study drug or any of its components.\n4. Prior history of receiving targeted therapy with specific KRAS G12D inhibitors\u002Fdegraders or pan-RAS inhibitors\u002Fdegraders for KRAS G12D mutation.\n5. Has undergone major surgery within 28 days prior to the first dose of study drug.\n6. Patients with symptomatic brain or leptomeningeal metastases.\n7. Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.\n8. Have protocol-defined clinically significant cardiovascular diseases.\n9. Prolonged QTcF interval.\n10. Patients with dyspnea at rest secondary to complications of advanced malignancy, or requiring continuous oxygen therapy due to other medical conditions.\n11. Patients with active pulmonary tuberculosis (TB).\n12. Patients with a known history of interstitial lung disease (ILD).\n13. Patients with a known history of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n14. Have experienced a severe concurrent infection within 28 days prior to the first dose of study drug.\n15. Patients with congenital or acquired immunodeficiency.\n16. Female patients in pregnancy or lactation period.\n17. Patients with concomitant diseases or conditions deemed by the Investigator likely to interfere with protocol compliance.\n18. Patients unwilling or unable to comply with protocol-specified procedures.",{"count":64,"type":20},178,[23,66],"PHASE2","This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.",[69,70,71,30,72,73,74],"Advance Solid Tumors","Colon and Rectal Cancer","Non - Small Cell Lung Cancer NSCLC","Ovarian Cancer","Endometrial Cancer","Biliary Cancers","2026-06-07",{"date":44,"type":47},{"date":78,"type":47},"2026-06-01",{"date":80,"type":20},"2029-05",{"name":82,"class":54},"Shenzhen Ionova Life Sciences Co., Ltd.",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100585075","phase-3-gemcitabine-plus-nab-paclitaxel-as-switch-maintenance-versus-continuation-of-modified-folfirinox-as-1st-line-chemotherapy-in-patients-with-advanced-pancreatic-cancer-100585075","NCT06897644","Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.","Gemcitabine Plus Nab-PAclitaxel as Switch maiNTEnance Versus cONtinuation of Modified FOLFIRINOX as First-line Chemotherapy in Patients With Advanced Pancreatic Cancer: the PANThEON Phase III Trial","PANThEON","Inclusion Criteria:\n\n* Patient able and willing to provide written informed consent and to comply with the study protocol.\n* Subjects must be ≥18 years.\n* Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic adenocarcinoma eligible for treatment in the first-line setting.\n* Presence of measurable or non-measurable disease assessed by CT scan and\u002For MRI according to RECIST 1.1. Note: any lesion which has been subjected to percutaneous therapies or radiotherapy should not be considered measurable, unless the lesion has clearly progressed since the procedure.\n* Availability of archival tumor sample (primary tumor or metastatic site) for biomarker analysis.\n* ECOG performance status of 0-1 (if age \\\u003C 70 years). If age ≥70 years, ECOG PS must be 0.\n* Estimated life expectancy \\> 3 months.\n* Adequate baseline hematologic function characterized by the following at screening:\n\n  * Absolute Neutrophil Count (ANC) ≥ 1.5 × 109\u002FL.\n  * Platelets count ≥ 100 × 109\u002FL.\n  * Hemoglobin ≥ 9 g\u002Fdl. Note: prior transfusions for patients with low hemoglobin are allowed.\n* Adequate liver function characterized by the following at screening:\n\n  * Serum total bilirubin ≤ 1.5 × ULN and \\\u003C 2 mg\u002FdL. Note: Subjects with Serum total bilirubin ≥ 1.5 × ULN and conjugated bilirubin ≤ ULN or \\\u003C 40% of total bilirubin are allowed.\n  * Serum transaminases (AST and\u002For ALT) \\\u003C 3 x ULN (\\\u003C 5 x ULN in presence of liver metastasis). In participants with elevated AST or ALT, the values must be stable for at least 2 week and with no evidence of biliary obstruction by imaging.\n* Adequate renal function, i.e. serum creatinine ≤ 1.5 x institutional ULN and calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL\u002Fmin.\n* Adequate coagulation functions as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy).\n* No presence of complete dihydropyrimidine dehydrogenase (DPYD) enzyme deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT) with DPYD gene testing mandatory at screening as per national guidelines. UDP-glucuronosyltransferase 1A1 (UGT1A1) testing is not mandatory. However, if UGT test is routinely performed in the participating centers, enrolment of patients carriers of variants of DPYD and homozygous variant UGT1A1 \\[7\u002F7\\] has to be discussed with the Sponsor.\n* Women of childbearing potential must agree to remain abstinent (refrain from sexual intercourse) or use highly effective contraceptive methods, as defined in APPENDIX V of the full protocol, during the treatment period and for at least 7 months after the last administration of study treatments.\n* Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women \\\u003C1 year after the onset of menopause.\n* Men must agree to remain abstinent (refrain from sexual intercourse) or use highly effective contraceptive methods during the treatment period and for at least 7 months after the last administration of study treatments.\n* Participants must agree not to donate eggs\u002Fsperm for future use for the purposes of assisted reproduction during the study and for a period of 7 months after receiving the last dose of study treatment. Female and male participants should consider preservation of eggs\u002Fsperm prior to study treatment as anti-cancer treatments may impair fertility.\n\nExclusion Criteria:\n\n* Pancreatic neuroendocrine, acinar, squamous\u002Fadenosquamous, or islet tumors.\n* Previous or concurrent systemic (e.g. cytotoxic or targeted or other experimental drugs) therapy for advanced pancreatic adenocarcinoma.\n\nNote: previous (neo)adjuvant or perioperative anti-cancer therapy for non-metastatic, resectable or borderline resectable PDAC, associated with surgery on the primary tumor, is allowed if \\> 9 months have elapsed from the last dose of therapy and documented disease progression or relapse.\n\n* Major surgery or radiation therapy performed within \\\u003C4 weeks before randomization. Palliative radiotherapy to bone lesions is allowed if performed \\> 2 weeks prior to start of study treatment. Patients must have recovered from an effect from major surgery.\n* Known allergy or hypersensitivity to study drugs and\u002For their excipients.\n* Unresolved toxicity ≥ CTCAE grade 2 attributed to any prior therapies (e.g. grade ≥2 peripheral neurotoxicity), excluding anemia or alopecia.\n* Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that requires directed therapy (such as radiotherapy or surgery) or increasing doses of corticosteroids 2 weeks prior to study entry. Participants with treated symptomatic brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study entry.\n* Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years prior to study entry except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer.\n* Know active uncontrolled hepatitis B or hepatitis C. Patients with a past or resolved HBV infection are eligible. Patients with chronic disease controlled by antiviral therapy or requiring prophylactic treatment are eligible.\n* Chronic or current active infectious disease requiring systemic antibiotics or antifungal treatment within 2 weeks prior to enrollment.\n* Known uncontrolled HIV infection. HIV-positive patients are eligible if their CD4+ cell count amounts to 300 cells per μL or more; HIV viral load must be undetectable per standard of care assay, and patients must be compliant with antiretroviral treatment.\n* Pregnant or breast-feeding patient, or patient planning to become pregnant within 7 months after the end of treatment.\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA \\> II, unstable angina pectoris, history of myocardial infarction within 3 months before study entry, significant arrhythmia).\n* Presence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent.\n* Any serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial.",{"count":93,"type":20},340,[95],"PHASE3","PANThEON is a randomized, open-label, multicenter phase III trial aimed at comparing the switch maintenance with gemcitabine plus nab-paclitaxel (ARM B) versus mFOLFIRINOX continuation (ARM A) in terms of overall survival (OS) in patients with unresectable LAD or mPDAC without disease progression following 3 months of induction mFOLFIRINOX triplet chemotherapy.",[30],[99,100,101,102,103,104,105],"first line","mFOLFIRINOX","chemotherapy","pancreas","Gemcitabine with Nab-Paclitaxel","switch maintenance","pancreatic cancer","2025-05-23",{"date":108,"type":47},"2025-05-25",{"date":110,"type":47},"2025-03-27",{"date":112,"type":20},"2030-01-01",{"name":114,"class":115},"Gruppo Oncologico del Nord-Ovest","OTHER",28]