[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-ductal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-ductal-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100578575","phase-2-using-tumor-models-to-determine-treatments-100578575",false,"NCT06813079","Using Tumor Models to Determine Treatments","ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial","Inclusion Criteria:\n\n1. Age 18 years or over\n2. Ability to understand and willing to sign a written informed consent form in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to screening to document their willingness to participate.\n3. Advanced inoperable malignant epithelial pancreatic ductal carcinomas (i.e. primary diagnosis of ductal adenocarcinoma or acinar cell adenocarcinoma, inclusive of all subtypes)\n4. Treatment history meeting one of either:\n\n   1. Stable disease or partial response to FOLFIRINOX (leucovorin calcium\u002Ffolinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin) after at least eight cycles of treatment (Cohort B)\n   2. Progression of disease after receiving standard of care chemotherapies (Cohort A).\n\n   i. There is no maximum number of prior lines\n\n   ii. Patients with recurrence within six months of adjuvant-intent chemotherapy will be eligible\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n6. Life Expectancy of greater than 12 weeks\n7. Patients must have acceptable organ function\n8. Patients must have baseline hepatitis B screening. If they have a positive surface antigen the case will discussed with the hepatologist to determine if therapy is indicated. This does not exclude them from study.\n9. Patients must agree to use effective contraceptive methods for the period required by the study.\n10. Patients must have measurable disease\n11. Patient-derived organoid is sensitive to a drug listed for this study, defined by\n\n    1. Consensus agreement in molecular tumor boards, considering the totality of the genomic and organoid data, and the safety profile of the drug, and the clinical situation\n    2. Sensitivity to a drug chosen for the study, based on\n\n    i. IC50 \\\u003C Cmax (maximum plasma concentration) ii. Area under the curve (AUC) \\\u003C 30th percentile of cohort iii. Individual assay fulfills quality control metrics c. Matched clinical scenario (maintenance versus treatment) as outlined in this protocol.\n12. Able to swallow and tolerate oral medication (as applicable)\n\nExclusion Criteria:\n\n1. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n2. Patient received last dose of chemotherapy within 21 days prior to Cycle 1 Day 1.\n3. Patients with ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2, other than peripheral neuropathy, related to prior anti-tumour treatment.\n4. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.\n5. Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates). These medications must have been started ≥ one month prior to enrolment in this study.\n6. Patients with a history of a severe allergic reaction attributed to compounds of similar or biologic composition to the PDO matched drug may be excluded if assessed by the investigator and determined to be unsafe to proceed.\n7. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.\n8. Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.\n9. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.\n10. Patients with known left ventricular ejection fraction (LVEF) \\\u003C 40 % as determined by a multigated acquisition (MUGA) scan or echocardiogram.\n11. Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.\n12. Patients with acute gastrointestinal bleeding within one month prior to the screening step.\n13. Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness\u002Fsocial situations.\n14. Lactating and nursing women.\n15. Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug.",[26,27,28],"Pancreatic Ductal Carcinoma","Advanced Cancer","Epithelial Tumor","RECRUITING","2026-06-19",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":33},"2025-04-07",{"date":37,"type":20},"2028-02-17",{"name":39,"class":40},"University Health Network, Toronto","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100461404","phase-1-phase-12a-study-of-jab-21822-plus-jab-3312-in-patients-with-advanced-solid-tumors-harboring-kras-pg12c-mutation-100461404","NCT05288205","Phase 1\u002F2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation","A Phase 1\u002F2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation","Inclusion Criteria:\n\n* A written informed consent should be signed by a subject or his\u002Fher legal representative before any study-related procedures are performed;\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC;\n* Expected survival ≥ 3 months;\n* Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression confirmed by radiography may be selected as the target lesion;\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;\n* The organ functions of subjects meet the criteria for the following laboratory parameters at screening;\n* Subjects must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption\n\nExclusion Criteria:\n\n* Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for \\> 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled;\n* Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.);\n* Patients with previous (≤ 6 months before the initiation of treatment) or current severe autoimmune diseases (including adverse reactions caused by previous anti- tumor immunotherapies), or autoimmune diseases requiring long-term systemic hormone therapy at immunosuppressive dose levels (prednisone \\> 10 mg\u002Fday or equivalent drugs);\n* HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive;\n* Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident;\n* Subjects who have impaired cardiac functions or clinically significant cardiac diseases;\n* Pregnant or lactating women",{"count":50,"type":20},240,[52,23],"PHASE1","This is a multicenter, open-label phase 1\u002F2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.",[55,56,57,26],"KRAS P.G12C","Non-small Cell Lung Cancer","Colorectal Cancer","2025-04-03",{"date":60,"type":33},"2025-04-04",{"date":62,"type":33},"2022-04-14",{"date":64,"type":20},"2026-03",{"name":66,"class":67},"Allist Pharmaceuticals, Inc.","INDUSTRY",27]