[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-pancreatic-ductal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-pancreatic-ductal-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,51,76,104,134,156,208,230,253,278,311,335,356,377,399,462,486,507,528,549],{"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":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100592131","phase-2-a-study-to-learn-about-the-medicine-ponsegromab-in-adults-with-cancer-of-the-pancreas-which-has-spread-and-caused-significant-body-weight-loss-and-fatigue-100592131",false,"NCT06989437","A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue","A Phase 2b\u002F3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma","Key inclusion Criteria:\n\n* Signed Informed Consent Document\n* Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma\n* Cachexia defined by Fearon criteria of weight loss\n* Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy\n* ECOG PS ≤1 with life expectancy of at least 4 months\n\nKey Exclusion Criteria:\n\n* Current active reversible causes of decreased food intake\n* Cachexia caused by other reasons\n* Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification\n* Left ventricular ejection fraction \\\u003C50%\n* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization\n* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody\n* History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients\n* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases\n* Inadequate liver function\n* Renal disease requiring dialysis or eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2","ALL","18 Years",{"count":19,"type":20},982,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.",[27,28],"Cachexia","Metastatic Pancreatic Ductal Adenocarcinoma",[30,31,32,33,34,35,36,37],"pancreatic cancer","metastatic cancer","cancer","anorexia","cachexia","weight loss","loss of appetite","fatigue","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":42},"2025-10-03",{"date":46,"type":20},"2029-12-10",{"name":48,"class":49},"Pfizer","INDUSTRY",211,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100630640","phase-2-a-study-to-assess-intravenous-iv-telisotuzumab-adizutecan-in-combination-with-fluorouracil-folinic-acid-and-oxaliplatin-folfox-compared-to-standard-of-care-in-adult-participants-with-first-line-metastatic-pancreatic-ductal-adenocarcinoma-100630640","NCT07490301","A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma","Phase 2\u002F3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination With FOLFOX Compared to Standard of Care in Subjects With First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288","Inclusion Criteria:\n\n* Have unresectable, metastatic histologically- or cytologically-confirmed adenocarcinoma of the pancreas\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Must consent to provide archived or recently obtained tumor tissue during Screening\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Have prior systemic therapy, surgery, or radiation (except palliative radiation) in the unresectable, locally advanced or metastatic setting\n* Prior c-MET targeting therapy\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Prior bone marrow transplant, solid organ transplant, or previous clinical diagnosis of tuberculosis.",{"count":59,"type":20},900,[23,24],"Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan when given in combination with fluorouracil, folinic acid, and oxaliplatin (FOLFOX) to treat adult participants with pancreatic ductal cancer.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study will be divided into two phases, with the first phase (Phase 2) treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX. Participants will then be randomized into 3 groups called treatment arms. Two groups will receive telisotuzumab adizutecan with FOLFOX with different optimized doses. One group will receive standard of care (SOC) - fluorouracil, leucovorin, oxaliplatin, and irinotecan. In the second phase (Phase 3), participants will be randomized into 2 arms to receive either the optimal dose of telisotuzumab adizutecan (from the previous phase) with FOLFOLX, or SOC. Approximately 900 participants with PDAC will be enrolled in this study in approximately 200 sites worldwide.\n\nPhase 2 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage, participants will receive escalating doses of Intravenous (IV) telisotuzumab adizutecan + FOLFOX. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with FOLFOX or SOC. At the start of Phase 3, participants will receive the optimal dose of IV telisotuzumab adizutecan with FOLFOX or SOC. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[28,63],"PDAC",[28,63,65],"Telisotuzumab adizutecan","2026-06-26",{"date":68,"type":42},"2026-06-30",{"date":70,"type":42},"2026-04-30",{"date":72,"type":20},"2031-06",{"name":74,"class":49},"AbbVie",17,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100642767","phase-1-testing-the-combination-of-anti-cancer-drugs-selumetinib-and-ds-8201a-for-advanced-pancreatic-ductal-adenocarcinoma-100642767","NCT07619521","Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a, for Advanced Pancreatic Ductal Adenocarcinoma","Phase I\u002FII Study of the MEK Inhibitor Selumetinib Plus DS-8201a in KRAS-Mutant, HER2-Expressing Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Review of eligibility criteria by the study principal investigator (PI) is required prior to enrollment\n* Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas\n* Patients must have unresectable or metastatic disease with KRAS mutation per Next Generation Sequencing (NGS) tumor testing and HER2 immunohistochemistry (IHC) positivity (2+ or above for dose escalation and per decision rule for phase II), as determined by a Clinical Laboratory Improvement Act (CLIA)-certified kit using gastric cancer criteria\n* Patients must have measurable disease that can fulfill Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria\n* Patients must have exposure to at least one line of systemic chemotherapy for metastatic or unresectable PDAC (for both escalation and phase II cohorts) or a documented patient decision to forego therapy that has an otherwise proven survival advantage (for escalation cohort only)\n* Patients who have received prior topoisomerase inhibitors including irinotecan and nanoliposomal irinotecan will be eligible for this study\n* Only 1 prior line of therapy for metastatic or unresectable PDAC will be allowed for patients in the phase II cohort. Adjuvant or neoadjuvant therapy does not count, assuming it was completed \\> 6 months prior to the start of systemic therapy for metastatic or unresectable disease\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of selumetinib (AZD6244 hydrogen sulfate) in combination with DS-8201a in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%). Regardless of performance status, enrollment should be based on the judgment of the treating physician that the patient will be able to be safely treated with the proposed therapeutic intervention\n* Hemoglobin ≥ 9 g\u002FdL (within 14 days of enrollment)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n* Leukocytes ≥ 3,000\u002FmcL (within 14 days of enrollment)\n* Absolute neutrophil count ≥ 1,500\u002FmcL (within 14 days of enrollment)\n\n  * No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment\n* Platelets ≥ 100,000\u002FmcL (within 14 days of enrollment)\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), (\\\u003C 3 × ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline) (within 14 days of enrollment)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\\u003C 5 × ULN in participants with liver metastases (within 14 days of enrollment)\n* Serum albumin ≥ 2.5 g\u002FdL (within 14 days of enrollment)\n* International Normalized Ratio (INR)\u002FProthrombin Time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (within 14 days of enrollment)\n* Creatine phosphokinase (CPK) ≤ 2.5 × ULN (within 14 days of enrollment)\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 (within 14 days of enrollment)\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging, performed at least 6 months after central nervous system (CNS)-directed therapy, shows no evidence of progression\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must undergo a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible, patients must be NYHA Class II or better and have no history of myocardial infarction within 6 months prior to enrollment, no symptomatic congestive heart failure (NYHA Class IIb-IV), and no troponin levels consistent with myocardial infarction (as defined by the manufacturer) within 28 days prior to enrollment\n* Patients must have a baseline left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram (ECHO) or mutilated acquisition scan (MUGA) scan within 28 days before randomization\u002Fenrollment\n* Patients must be willing to undergo baseline ophthalmic evaluation, including visual acuity and slit-lamp examination\n* The effects of selumetinib (AZD6244 hydrogen sulfate) and DS-8201a on the developing human fetus are unknown. For this reason and because MEK inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months (for WOCBP) or 4 months (for men) after completion of drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU\u002FmL and estradiol \\\u003C 40 pg\u002FmL \\[\\\u003C 147 pmol\u002FL\\] is confirmatory) are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study\n* Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients with prior MEK inhibitor, ERK inhibitor, or HER2-directed therapy treatment\n* Patients who have had chemotherapy (including antibody drug therapy, retinoid therapy, hormonal therapy for cancer) within 3 weeks (2 weeks or five half-lives, whichever is longer for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents), weekly paclitaxel; 6 weeks for nitrosoureas or mitomycin C\n* Patients who have had immunotherapy including monoclonal antibody therapy within 4 weeks\n* Patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies\n* Patients who have had a major surgery within 4 weeks\n* Patients with a history of allogeneic organ or stem cell transplant\n* Patients who are receiving any other investigational agents or received any other investigational agents within the past 21 days prior to protocol treatment initiation\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib (ADZ6244 hydrogen sulfate) or DS-8201a\n* Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment\n* Patients with prior use of immunosuppressive medication within 14 days prior to first study dose, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses less than 10 mg\u002Fday of prednisone or equivalent\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Patients with a corrected QT interval (QTc) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Patients with a history of (non-infectious) interstitial lung disease (ILD) that required steroids, presence of ILD that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity, or where suspected ILD cannot be ruled out by imaging at screening. These patients will be excluded because DS-8201a is known to increase the risk of developing ILD and pneumonitis\n* Patients with lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months prior to study enrollment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, significant pleural effusion, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), and\u002For prior pneumonectomy. These patients will be excluded because DS-8201a is known to increase the risk of developing ILD and pneumonitis\n* Patients with gastrointestinal conditions which could impair absorption of selumetinib (AZD6244 hydrogen sulfate) or inability to ingest selumetinib (AZD6244 hydrogen sulfate)\n* Patients with a history of significant retinal pathology (including but not limited to, retinal vein occlusion, retinal detachment, or macular degeneration) or clinically significant ophthalmic abnormalities that may increase the risk of retinal adverse events\n* Active ocular disease requiring systemic therapy or current use of contact lenses that may interfere with ophthalmic evaluations\n* Based on pre-clinical and clinical data, DS-8201a and selumetinib (AZD6244 hydrogen sulfate) are associated with ocular toxicity. Patients with clinically significant corneal disease, in the opinion of the investigator, will be excluded from this study\n* Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic body radiation therapy). These patients will be excluded because DS-8201a is known to increase the risk of developing pneumonitis\n* Patients with spinal cord compression, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n* Patients that have received a live vaccine within 30 days prior to the first dose of study drug will be excluded. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia or peripheral neuropathy) not yet resolved to grade ≤ 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee (e.g., grade 2 chemotherapy-induced neuropathy). Subjects should no longer be symptomatic nor require treatment with corticosteroids or anticonvulsants and must have recovered from the acute toxic effect of radiotherapy\n* Patients with ongoing muscle disorders or elevated baseline creatine phosphokinase (CPK) levels suggestive of rhabdomyolysis or myopathy\n* Patients currently using high-dose vitamin E supplements exceeding the recommended daily intake (≥ 400 IU\u002Fday) or concurrent use of anticoagulants\u002Fantiplatelets that may increase bleeding risk, unless clinically indicated and closely monitored\n* Pregnant women are excluded from this study because selumetinib (AZD6244 hydrogen sulfate) is a MEK inhibitor agent with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with selumetinib (AZD6244 hydrogen sulfate) breastfeeding should be discontinued if the mother is treated with selumetinib (AZD6244 hydrogen sulfate). These potential risks also apply to treatment with DS-8201a\n* Patients who have received prior systemic anticancer therapy, investigational agents, or radiotherapy without completion of an adequate washout period prior to study treatment initiation defined as at least 14 days or \\> 5 half-lives of the prior agent (whichever is shorter). This applies to therapies with potential overlapping toxicities with DS-8201a or selumetinib (AZD6244 hydrogen sulfate) including but not limited to agents associated with pulmonary toxicity, cytopenias, or gastrointestinal toxicity",{"count":84,"type":20},31,[86,23],"PHASE1","This phase I\u002FII trial tests the safety, side effects, best dose and how well giving selumetinib with DS-8201a works for the treatment of pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. DS-8201a is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving selumetinib with DS-8201a may be safe, tolerable and\u002For effective in treating patients with advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.",[89,28,90,91,92],"Advanced Pancreatic Ductal Adenocarcinoma","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Unresectable Pancreatic Ductal Adenocarcinoma","NOT_YET_RECRUITING","2026-06-10",{"date":96,"type":42},"2026-06-11",{"date":98,"type":20},"2026-09-08",{"date":100,"type":20},"2026-10-30",{"name":102,"class":103},"National Cancer Institute (NCI)","NIH",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100642548","phase-1-study-of-jab-23e73-in-combination-with-chemotherapy-in-participants-with-metastatic-pdac-harboring-kras-gene-alterations-100642548","NCT07640295","Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations","A Multicenter, Phase Ib\u002FIII Study to Evaluate JAB-23E73 in Combination With Nab-Paclitaxel and Gemcitabine in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Harboring KRAS Gene Alterations","Inclusion Criteria:\n\n1.Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.\n\n3\\. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).\n\n5\\. ECOG performance status score of 0 or 1. 6. Adequate organ function.\n\nExclusion Criteria:\n\n1. Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.\n2. A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.\n3. Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS inhibitors, or other agents of the same class.\n4. Primary central nervous system (CNS) tumors.\n5. Women who are pregnant or breast-feeding.\n6. Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.",{"count":112,"type":20},80,[86,23],"The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.",[28],[117,118,119,120,121,122,123,124],"KRAS","KRAS mutation","KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A,","Pan-KRAS","Pancreatic ductal adenocarcinoma","KRAS-mutant tumor","Targeted Therapy","JAB-23E73","2026-06-08",{"date":94,"type":42},{"date":128,"type":20},"2026-06-22",{"date":130,"type":20},"2030-12-31",{"name":132,"class":49},"Jacobio Pharmaceuticals Co., Ltd.",13,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":155},"100609416","phase-1-pegcetacoplan-in-combination-with-modified-folfirinox-for-the-treatment-of-metastatic-pancreatic-ductal-adenocarcinoma-100609416","NCT07214298","Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma","A Phase I\u002FII Study of Complement Inhibition in Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic PDAC\n* Age ≥ 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Absolute neutrophil count ≥ 1,500\u002FuL\n* Platelets ≥ 100,000\u002FuL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Estimated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault equation)\n* Albumin ≥ 3 g\u002FdL\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present\n* All patients must either have available archival tumor tissue or undergo new tumor biopsy (if presence of a lesion that can be safely biopsied) before treatment initiation for correlative studies\n* Willing and able to self-administer pegcetacoplan (administration by caregiver will be allowed)\n* Willing to receive vaccination against Neisseria meningitidis and Streptococcus pneumoniae if not already vaccinated\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\n  * Women of child-bearing potential taking part in this study should continue the use of birth control for 6 months after the last study treatment, and should not donate eggs during that timeframe\n  * Male participants taking part in this study should continue the use of birth control for 3 months after the last study treatment, and should not donate sperm during that timeframe\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Previous chemotherapy for PDAC. Gemcitabine-based post- or pre-operative therapy is allowed provided that the last dose and or surgical resection was at least 6 months prior to the documentation of metastatic disease, whichever occurred last\n* Toxicities from prior treatment grade \\> 1 with the exemption of alopecia and fatigue\n* Refractory ascites or pleural effusion (requiring para- or thoracentesis weekly or more frequently or use of indwelling catheter for palliation)\n* Untreated bowel or gastric outlet obstruction; patients with ≤ 6 weeks from such an event who are adequately palliated are allowed to participate\n* Participants with known untreated brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with major arterial thromboembolism (ATE) (coronary, cerebral, extremity or splanchnic) or venous thromboembolism (VTE) (pulmonary embolism or deep venous thrombosis) within 6 months from initiation of study treatment are not eligible for participation\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug",{"count":142,"type":20},35,[86,23],"This phase I\u002FII trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). Pegcetacoplan works by targeting the immune complement process, a part of the immune system that defends against bacteria and may limit tumor progression and improve the immune system's response against tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Leucovorin is a drug used to lessen the toxic effects of substances that block the action of folic acid. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Fluorouracil stops cells from making DNA and it may kill tumor cells. It is a type of antimetabolite. Giving pegcetacoplan in combination with mFOLFIRINOX may be safe, tolerable, and\u002For effecting in treating patients with metastatic PDAC. This trial also evaluates the effect of pegcetacoplan on the incidence of major thrombotic events and the resulting complications. Thrombosis is a common complication in patients with PDAC. Thrombosis occurs when blood clots block veins or arteries. Complications of thrombosis, such as stroke or heart attack, can be life-threatening. Giving pegcetacoplan may help prevent blood clots from forming and decrease the risk of major thrombotic events.",[28,91],"2026-06-04",{"date":125,"type":42},{"date":149,"type":42},"2026-02-16",{"date":151,"type":20},"2028-10-01",{"name":153,"class":154},"Roswell Park Cancer Institute","OTHER",1,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":181,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":75},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":164,"type":20},665,[86],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[168,169,170,171,172,173,174,175,176,177,178,28,179,180],"Non-Small Cell Lung Cancer","NSCLC","PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","KRAS G12A","KRAS G12C","KRAS G12D","KRAS G12S","KRAS G12V","Advanced Lung Carcinoma","Solid Tumor, Adult",[182,183,184,185,169,186,63,187,188,189,190,191,192,193,194,195,196,197,198],"BBOT","BridgeBio Oncology Therapeutics","Phase1","Phase 1a\u002F1b","CRC","Metastatic Cancer","Advanced Cancer","Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","Nab-paclitaxel","2026-05-29",{"date":201,"type":42},"2026-06-02",{"date":203,"type":42},"2025-03-31",{"date":205,"type":20},"2029-09",{"name":207,"class":49},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100605702","phase-3-clinical-trial-comparing-tqb2868-injection-combined-with-anlotinib-hydrochloride-capsules-with-placebo-combined-with-chemotherapy-as-first-line-treatment-for-metastatic-pancreatic-ductal-adenocarcinoma-mpdac-100605702","NCT07165951","Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)","A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules to Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)","Inclusion Criteria:\n\n1. The subjects voluntarily joined this study, signed the Informed Consent Form (ICF), and showed good compliance;\n2. On the date of signing the ICF, aged between 18 and 75 years old (inclusive);\n3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by tissue or cytology;\n4. According to the American Joint Commission on Cancer (AJCC) 8th Edition Tumor, Node, Metastasis (TNM) staging system for pancreatic cancer, patients with stage IV metastatic pancreatic cancer;\n5. Have not received any systemic anti-tumor treatment or investigational drug therapy; If receiving neoadjuvant\u002Fadjuvant therapy, the time interval between the last administration and recurrence\u002Fprogression must be ≥ 6 months, and the toxicity related to anti-tumor therapy has recovered to ≤ level 1 or the toxicity level specified in the inclusion criteria (excluding hair loss); According to RECIST v1.1, there is at least one measurable lesion. If the lesion has undergone local treatment (radiotherapy, ablation, interventional therapy, etc.) in the past, it must be clearly proven to have progressed in accordance with RECIST v1.1 before it can be considered a measurable lesion;\n\n7\\. Eastern Cooperative Oncology Group (ECOG) score from 0 to 1; Expected survival is greater than 12 weeks; 9. The laboratory inspection meets the protocol standards; 10. Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study, and have a negative serum test within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period;\n\nExclusion Criteria:\n\n1. Have had or currently have other malignant tumors within the past 5 years prior to the first use of medication;\n2. There are various factors that affect intravenous injection, venous blood collection diseases, or oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);\n3. Adverse reactions from previous treatments have not recovered to NCI CTCAE v5.0 score ≤ 1, except for toxicity that has been determined by researchers to have no safety risks, such as grade 2 hair loss, grade 2 peripheral neurotoxicity, non clinically significant, and asymptomatic laboratory abnormalities;\n4. Those who have received major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks before the first medication, or have long-term untreated wounds or fractures;\n5. Subjects who experience any bleeding or bleeding events ≥ NCI CTCAE v5.0 grade 3 within 4 weeks prior to the first administration;\n6. Individuals who have experienced arterial\u002Fvenous thrombotic events within 6 months prior to the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, or any other history of severe thromboembolism (implantable venous infusion port or catheter-related thrombosis, or superficial vein thrombosis is not considered \"severe\" thromboembolism);\n7. hepatitis B virus (HBV) infected individuals cannot receive regular antiviral treatment throughout the entire process; HCV infected individuals (HCV Ab or HCV RNA positive): Researchers determine that they are in an unstable state or need to continue antiviral treatment. Regular antiviral treatment cannot be accepted during the study;\n8. Active syphilis infected individuals who require treatment;\n9. History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;\n10. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;\n11. Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;\n12. Subjects with any severe and\u002For uncontrolled illnesses;\n13. Subjects who require immunosuppressive therapy, systemic or absorbable local hormone therapy to achieve immunosuppression and continue to use it within 7 days prior to the first dose (excluding corticosteroids with a daily dose of\\\u003C10 mg prednisone or other therapeutic hormones);\n14. Tumor related symptoms are difficult to control;\n15. Known to be allergic to the components of research drug excipients;\n16. Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;\n17. Pregnant or breastfeeding subjects; According to the judgment of the researchers, there are serious situations that pose a threat to the safety of the subjects or affect their ability to complete the study.","75 Years",{"count":217,"type":20},566,[24],"This study adopts a randomized, open label, placebo-controlled, multicenter trial design. OS was the primary endpoint, and eligible subjects were randomly divided into 1:1 groups and received TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy, compared to placebo combined with chemotherapy.",[28],"2026-05-28",{"date":199,"type":42},{"date":224,"type":42},"2025-12-02",{"date":226,"type":20},"2028-12",{"name":228,"class":49},"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.",71,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":155},"100585593","phase-1-ont01-and-gemcitabinenab-paclitaxel-as-second-line-therapy-for-metastatic-pancreatic-ductal-adenocarcinoma-100585593","NCT06904378","ONT01 and Gemcitabine\u002FNab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma","Phase I\u002FII Clinical Trial of ONT01 and Gemcitabine\u002FNab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma: Reprogramming Tumor-associated Myeloid Cells","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the pancreas.\n* Measurable or evaluable disease per RECIST 1.1.\n* Previously treated with first-line systemic therapy for unresectable\u002Fadvanced or metastatic PDAC and experienced progression or became intolerant to the therapy and is in need of another line of systemic therapy in the opinion of the investigator.\n* At least 18 years of age.\n* ECOG performance status ≤ 1.\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN\n  * Creatinine ≤ 1.5 x IULN or Creatinine clearance \\> 50 mL\u002Fmin by Cockcroft-Gault\n* The effects of ONT01 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days after last dose of ONT01 or 180 days after last dose of nab-paclitaxel\u002Fgemcitabine. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Received more than one line of treatment or received gemcitabine or nab-paclitaxel in the metastatic setting. Prior therapy in the adjuvant or neoadjuvant therapy will count as a line of treatment if progression occurred less than 6 months after the last dose of systemic therapy. The following exception applies:\n\n  * If treated in the adjuvant or neoadjuvant setting with systemic therapy and progression occurred greater than 6 months after last dose, the adjuvant or neoadjuvant systemic therapy may have included gemcitabine or nab-paclitaxel. If progression occurred within 6 months of the last dose of systemic therapy in the adjuvant or neoadjuvant setting, then that therapy must not have included gemcitabine or nab-paclitaxel.\n* Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment.\n* Major surgery (defined as surgery that requires general anesthesia) within 28 days of C1D1 of ONT01 (phase I portion) or date of randomization (phase II portion).\n* Chemotherapy, small molecular directed therapy, immunotherapy, and\u002For radiation therapy within 14 days of C1 of ONT01 (phase I portion) or date of randomization (phase II portion).\n* History of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease or 2) known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic PDAC (including but not limited to prostate adenocarcinoma Gleason 6 on surveillance, indolent follicular lymphoma on watch and wait surveillance, low risk CLL on surveillance, non-metastatic cutaneous basal cell or squamous cell carcinoma not requiring systemic therapy).\n* History of allogeneic organ or stem cell transplant.\n* Currently receiving any other investigational agents.\n* Patients with known, untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ONT01, gemcitabine, nab-paclitaxel, or other agents used in the study.\n* Average QTc \\>470 msec on screening EKGs.\n* Gastrointestinal condition which could prevent absorption of ONT01, or inability to digest ONT01, in the opinion of the PI or sub-investigator.\n* Clinically significant peripheral neuropathy grade 2 or worse.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days of C1D1 (phase I portion) or date of randomization (phase II portion).\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll after discussing with the Principal Investigator.\n* Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of C1D1 except for adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: treatment with a short course of steroids (\\\u003C 5 days) up to 7 days prior to C1D1 (phase I portion) or date of randomization (phase II portion) is permitted. Inhaled intranasal, intra-articular, and topical steroid uses are permitted.\n* Patients with known Gilbert's syndrome.",{"count":238,"type":20},61,[86,23],"The investigators hypothesize that CD11b agonism reprograms the tumor microenvironment (TME) to overcome resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma (PDAC). Therefore, the investigators propose an open label phase I\u002FII clinical trial of ONT01 with gemcitabine and nab-paclitaxel in unresectable pancreatic ductal adenocarcinoma prior to future studies incorporating anti-PD1 checkpoint immunotherapy.",[28],[243,197],"Pancreatic cancer CD11b","2026-05-15",{"date":246,"type":42},"2026-05-19",{"date":248,"type":42},"2026-03-25",{"date":250,"type":20},"2029-09-30",{"name":252,"class":154},"Washington University School of Medicine",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":155},"100565919","phase-1-mk2-inhibitor-in-combination-with-mfolfirinox-for-untreated-metastatic-pancreatic-ductal-adenocarcinoma-100565919","NCT06648434","MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma","Phase I Trial of MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma with no prior systemic treatment for advanced or metastatic disease. Patients with mixed cytology in their tumors such as adeno-squamous, mixed neuroendocrine-carcinoma are permitted if the portion of adenocarcinoma is predominant. Prior adjuvant\u002Fneoadjuvant therapy (including FOLFIRINOX or mFOLFIRINOX regimens) is allowed if progression occurred ≥ 12 months from the last dose of that therapy. A biopsy is not required to confirm advanced or metastatic disease.\n* Dose escalation: Diagnosis of advanced inoperable or metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician.\n* Dose expansion: Diagnosis of metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician.\n* Measurable disease by RECIST 1.1.\n* At least 18 years of age\n* ECOG performance status ≤ 1.\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm without transfusion within 2 weeks prior to C1D1\n  * Hemoglobin ≥ 9.0 g\u002FdL without transfusion within 2 weeks prior to C1D1\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN\n  * Creatinine clearance \\> 50 mL\u002Fmin by Cockcroft-Gault\n* Baseline EKG with QTcF ≤ 460 ms.\n* Women of childbearing potential and men who are heterosexually active must agree to use adequate contraception as specified in the protocol. Contraception should continue for 1 month following last dose of zunsemetinib, 6 months following last dose of irinotecan, 9 months following last dose of oxaliplatin, and\u002For 3 months following last dose of fluorouracil. Should a woman (or the female partner of a male participant) become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic pancreatic cancer.\n* History of allogeneic organ or stem cell transplant.\n* Currently receiving any other investigational agents, or receipt of an investigational agent within 2 weeks or 5 half-lives of the agent, whichever is shorter.\n* Receipt of strong and moderate CYP3A4 and CYP2C8 inhibitors (including grapefruit), strong and moderate CYP3A and CYP2C8 inducers (see Appendices H and I), and drugs with QT prolonging potential within 5 half-lives of cycle 1 day 1.\n* Known brain metastases or CNS involvement, because brain metastases are often associated with poor functional status, shortened life expectancy and risk of toxicity.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to zunsemetinib, or other agents used in the study.\n* Clinically significant neuropathy ≥ grade 2.\n* Presence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.\n* Gastrointestinal conditions which could prevent absorption of zunsemetinib, in the opinion of the treating physician.\n* Inability to swallow pills.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia .\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days of C1D1.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.\n* Major surgery within 28 days prior to C1D1. Major surgery refers to any surgical procedure that involves general or regional anesthesia, involves extensive resecting or altering of body parts, carries a higher risk of complications, or requires long recovery times. Central line placement is allowed.\n* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of C1D1.",{"count":261,"type":20},51,[86],"The investigators hypothesize that MK2 inhibition may improve efficacy of mFOLFIRINOX chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC).",[28,265,266],"Pancreatic Cancer","Cancer of the Pancreas",[268,269,270],"Pancreatic cancer","Zunsemetinib","FOLFIRINOX","2026-04-24",{"date":70,"type":42},{"date":274,"type":42},"2025-06-13",{"date":276,"type":20},"2030-05-31",{"name":252,"class":154},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":21,"phases":287,"briefSummary":288,"conditions":289,"keywords":293,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":310},"100550283","phase-1-study-of-rason-inhibitors-in-patients-with-gastrointestinal-solid-tumors-100550283","NCT06445062","Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","Inclusion Criteria:\n\nAll Patients (unless otherwise noted):\n\n* ≥ 18 years of age\n* ECOG PS is 0 to 1\n* Adequate organ function as outlined by the study\n* Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C)\n* Presence of RAS G12D mutation (Subprotocol D, E, F)\n\nExclusion Criteria:\n\nAll Patients:\n\n* Primary central nervous system (CNS) tumors\n* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs\n* Major surgery within 28 days of first dose\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":286,"type":20},1130,[86,23],"The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.\n\nThe current subprotocols include the following:\n\nSubprotocol A: RMC-6236 + 5-fluorouracil-based regimens\n\nSubprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6\n\nSubprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel\n\nSubprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens\n\nSubprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6\n\nSubprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel",[290,186,291,63,292,28],"Colorectal Cancer","Pancreatic Ductal Adenocarcinoma","Gastrointestinal Cancer",[186,63,294,295,290,265,296,297,298,299,300],"RAS Mutation","KRAS G12X","Pancreatic Ductal Carcinoma","KRAS Q61 Mutation","KRAS G12 Mutation","RAS Wild-type","RAS G12D Mutation","2026-03-26",{"date":303,"type":42},"2026-04-01",{"date":305,"type":42},"2024-05-24",{"date":307,"type":20},"2027-07-15",{"name":309,"class":49},"Revolution Medicines, Inc.",32,{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":155},"100599857","early-phase-1-omo-103-for-the-treatment-of-locally-advanced-or-metastatic-pancreatic-ductal-adenocarcinoma-100599857","NCT07089940","OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma","An Early Phase 1 Trial to Assess Pharmacodynamic Effects of OMO-103 in Patients With Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Must provide written informed consent before any study-specific procedures or interventions are performed\n* Must be ≥ 18 years old at the time of informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Clinically-confirmed diagnosis of locally-advanced or metastatic adenocarcinoma of the pancreas\n\n  * Participants may be treatment naïve or have received prior therapy for the treatment of their PDAC. A minimum washout period of 14-days after completing the most recent line of therapy is required before a participant can initiate treatment with study agent(s)\n* Based on available imaging, participant must have at least one disease lesion that can be biopsied in accordance with institutional standards\n* Patient agrees to undergo a minimum of 2 biopsies (pre- and post-treatment). Note: at principal investigator (PI) discretion, archival sample may be obtained in lieu of pre-treatment biopsy\n* Hemoglobin ≥ 7.5 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (\\> 1500 per mm\\^3)\n* Platelet count ≥ 75 x 10\\^9\u002FL (\\> 100,000 per mm\\^3)\n* Calculated creatinine clearance \\> 50 mL\u002Fmin\u002F1.73m\\^2 (per Cockcroft-Gault equation)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT): ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN in presence of liver metastases\n* Participants of childbearing potential (POCBP) must agree to abstain from sexual intercourse or use effective methods of contraception starting with the first dose of study therapy through 6 months from the last dose of study intervention\n* POCBP may participate provided they have a negative serum pregnancy test at screening and a negative serum OR urine pregnancy test within 7 days of starting treatment\n* Sperm-producing participants must agree to abstain from sexual intercourse or use effective contraception starting with the first dose through 6 months after last dose of study intervention\n\nExclusion Criteria:\n\n* Concomitant use of other anti-cancer therapy otherwise not permitted in this protocol, including: chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy, or other novel agent\n* Prior anti-cancer therapy within 2 weeks prior to study enrollment\n* Prior treatment with a MYC inhibitor\n* Known severe hypersensitivity to OMO-103 or to any excipient of these medicinal products, or history of allergic reactions attributed to compounds of similar chemical or biologic composition\n* Major surgery within 6 weeks prior to enrollment\n* Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial infarction within 3 months of initiating study intervention\n* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent\n* Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements",{"count":319,"type":20},12,[321],"EARLY_PHASE1","This early phase I trial studies the biological activity of OMO-103 in patients with pancreatic ductal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). OMO-103 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial may help researchers determine how exposure to OMO-103 changes pancreatic tumor cells.",[324,28,325,90,91],"Locally Advanced Pancreatic Ductal Adenocarcinoma","Stage II Pancreatic Cancer AJCC v8","2026-03-19",{"date":328,"type":42},"2026-03-23",{"date":330,"type":42},"2026-01-27",{"date":332,"type":20},"2027-12-31",{"name":334,"class":154},"OHSU Knight Cancer Institute",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":354,"locationsCount":4},"100629481","phase-1-rimegepant-combined-with-ag-chemotherapy-as-first-line-treatment-for-metastatic-pancreatic-ductal-adenocarcinoma-100629481","NCT07475234","Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma","A Phase Ib\u002FII Single-Arm, Single-Center, Prospective Clinical Study Of Rimegepant Combined With AG Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","RAG-MPDAC","Inclusion Criteria:\n\n1. The patient has good compliance, understands the study procedures, and has signed a written informed consent form.\n2. Age ≥ 18 years.\n3. Pathologically or cytologically confirmed pancreatic cancer, with imaging or pathological findings indicating unresectable pancreatic cancer with distant metastasis.\n4. Patients who have not received any prior treatment for pancreatic cancer (including radiotherapy, chemotherapy, or experimental therapy), except for surgical resection.\n5. If the patient has received neoadjuvant\u002Fadjuvant chemotherapy, the regimen must not contain AG, and the interval from the last administration to the diagnosis of recurrence must be \\>6 months, with no delayed toxicities.\n6. The patient has at least one measurable lesion according to the RECIST 1.1 criteria.\n7. ECOG performance status 0-1.\n8. Expected survival \\>3 months.\n9. Adequate organ function, defined as meeting the following criteria (blood tests to be completed within 14 days prior to enrollment):\n\n   1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL\n   2. Hemoglobin ≥90 g\u002FdL\n   3. Platelet count (PLT) ≥100 × 10⁹\u002FL\n   4. Total bilirubin \\\u003C1.5 × upper limit of normal (ULN)\n   5. Liver transaminases (AST \\& ALT) \\\u003C2.5 × ULN; for patients with liver metastases, AST\u002FALT ≤5 × ULN\n   6. Serum creatinine ≤1 × ULN, or creatinine clearance ≥50 mL\u002Fmin if serum creatinine \\>1 × ULN\n10. The patient has an adequate nutritional status, defined as BMI \\>18.5 kg\u002Fm².\n11. Female patients who are not pregnant or breastfeeding; sexually active men and women of childbearing potential must use effective contraception during the study and for 6 months after treatment completion.\n12. No contraindications to remimazolam or AG chemotherapy agents.\n\nExclusion Criteria:\n\n1. Patients with a history of other malignancies within the past 5 years, except for cured in situ carcinoma or basal cell carcinoma of the skin.\n2. Patients diagnosed with pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.\n3. Patients with refractory pleural effusion or ascites.\n4. Patients with known brain or meningeal metastases.\n5. Patients who used strong CYP3A4 inducers within 3 weeks prior to the first study drug administration, or strong CYP3A4\u002FUGT1A1 inhibitors within 3 weeks prior to the first study drug administration.\n6. Patients who underwent major organ surgery (excluding needle biopsy, central venous catheter insertion, port catheterization, biliary obstruction stenting, percutaneous transhepatic biliary drainage, and cholecystostomy) within 4 weeks prior to the first dose of study drug, or who plan to undergo elective surgery.\n7. Patients with known dihydropyrimidine dehydrogenase deficiency or low activity.\n8. Patients with active infection, including HIV infection, or chronic HBV\u002FHCV in the active phase (HBV DNA ≥10⁴ copies\u002FmL or ≥2000 IU\u002FmL; patients must receive antiviral therapy first, and can only be enrolled when HBV DNA \\\u003C10⁴ copies\u002FmL or \\\u003C2000 IU\u002FmL, with continued antiviral therapy and monitoring of liver function and HBV viral load).\n9. Patients with severe comorbidities, including poorly controlled diabetes despite anti-diabetic medication, clinically significant active heart disease, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, hemorrhagic peptic ulcer, ileus, or intestinal obstruction.\n10. Patients with severe diarrhea (grade ≥2 per NCI-CTCAE v5.0: ≥4 bowel movements per day vs baseline; moderate\u002Fsevere increase in stoma output; limitation of activities of daily living).\n11. Patients with severe psychiatric disorders.\n12. Patients with grade ≥II peripheral neuropathy at present or in the past.\n13. Patients with known hypersensitivity to benzodiazepines, AG chemotherapy agents, or related components.\n14. Patients who participated in other clinical trials within 4 weeks prior to enrollment.\n15. Patients deemed unsuitable for the trial by the investigator.",{"count":344,"type":20},30,[86,23],"This study aims to evaluate the efficacy and safety of Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer.",[28],"2026-03-12",{"date":350,"type":42},"2026-03-16",{"date":352,"type":20},"2026-03",{"date":226,"type":20},{"name":355,"class":154},"Xiuchao Wang",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":215,"enrollmentInfo":363,"targetDuration":4,"studyType":21,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":155},"100627181","phase-3-chiauranib-plus-pd-1-inhibitor-albumin-paclitaxel-and-gemcitabine-in-patients-with-metastatic-pancreatic-ductal-adenocarcinoma-100627181","NCT07445295","Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","A Phase III Study of Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the written informed consent form.\n2. Age 18-75 years on the day of signing the informed consent form, male or female.\n3. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.\n4. No prior systemic therapy for metastatic pancreatic ductal adenocarcinoma. Participants who have received prior induction chemotherapy, concurrent radiotherapy, or adjuvant\u002Fneoadjuvant chemotherapy with curative intent, the interval of recurrence or metastasis must be at least 6 months after the last treatment.\n5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Previously received local therapy lesion can be considered as measurable lesion unless imaging-confirmed progression.\n6. ECOG Performance Status 0 or 1.\n7. Life expectancy≥3 months.\n8. Major organ functions meet the following criteria(no blood transfusions, hematopoietic growth factors, albumin and other medications considered by the investigator to be corrective therapy within 14 days prior to examination, except for iron supplements): Hematology: hemoglobin≥90g\u002FL, absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets≥100×10\\^9\u002FL. Biochemistry: serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, AST\u002FALT≤2.5×ULN (≤5×ULN for patients with hepatic metastasis). Coagulation profile: INR \\\u003C 1.5×ULN(for participants undergoing prophylactic anticoagulation therapy, investigators should determine whether the INR is within a safe and effective therapeutic range).\n\nExclusion Criteria:\n\n1. Histological or cytological confirmed other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, pancreablastoma, etc.\n2. During screening, tumor invades major vessels (e.g., pulmonary artery, superior vena cava, or inferior vena cava) and significant risk of hemorrhage judged by the investigator; or known history of aneurysm.\n3. Presence of active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease during the screening period. However, enrolment is permitted for subjects who meet the following requirements and have measurable lesion outside the CNS: asymptomatic after treatment and stable on imaging for at least 28 days prior to the first dose (e.g., no new or enlarging brain metastases) and have been off systemic glucocorticosteroids and anticonvulsant medications for at least 14 days prior to the first dose.\n4. Presence of clinically symptomatic pleural effusion, pericardial effusion or ascites requiring frequent drainage (≥1 time\u002Fmonth) during the screening period.\n5. Previous received Aurora kinase inhibitors, or systemic treatment of VEGF\u002FVEGFR inhibitors such as bevacizumab, sorafenib, sunitinib, amlotinib, apatinib, and endostar, or immunotherapy drugs of PD-1, PD-L1, CTLA-4 inhibitors, etc.\n6. Previous radiation therapy, chemotherapy, immunotherapy, targeted therapy within 28 days prior to the first dose. Chinese patent medicine witn anti-malignancy effect approved by National Medical Products Administration within 14 days prior to the first dose.\n7. Adverse effects of prior antineoplastic therapy that have not returned to ≤grade 1 of CTCAE v5.0 criteria (except for alopecia without safety risk judged by the investigator and laboratory tests specified in Inclusion Criterion 8).\n8. Presence of peripheral neuropathy of CTCAE v5.0 criteria, Grade 2 or higher.\n9. Major surgery (craniotomy, thoracotomy, or laparotomy) or serious unhealed wounds, ulcers, or fractures within 28 days prior to the first dose. Needle biopsy or other minor surgery (except for intravenous infusion) within 7 days prior to the first dose.\n10. Significant arterial\u002Fvenous thrombotic events within 6 months prior to first dose, such as deep vein thrombosis and pulmonary embolism. Superficial vein thrombosis without safety risk judged by the investigator is permitted.\n11. Cardiac dysfunction or clinically meaningful cardiovascular disease, including: (1)New York Heart Association (NYHA) grade III\\~IV congestive cardiac failure, unstable angina pectoris, and\u002For myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) \\\u003C50% at screening. (2)Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy). (3)Clinically significant history of prolonged QTc interval, or QTcF interval \\>470ms for females or \\>450 ms for males during the screening period. (4)Coronary heart disease with symptoms requiring medication. (5)Documentation of hypertension treatment with≥3 antihypertensive medications simultaneously within 14 days before the first dose of medication or systolic blood pressure≥140 mmHg and\u002For diastolic blood pressure≥90 mmHg during the screening period (resting state, measured approximately every 5 minutes, averaged after three consecutive measurements, rounded to the nearest integer). (6)History of hypertensive crisis or hypertensive encephalopathy. (7)Other cardiovascular disease judged by the investigator to be unsuitable for enrolment.\n12. Active bleeding within 2 months prior to the first dose, or taking anticoagulants, such as warfarin, phenprocoumon (prophylactic low-dose aspirin and low-molecular heparin are permitted) during the screening period, or at high risk of bleeding judged by the investigator during screening period (e.g., esophageal varix associated with bleeding risk, locally active ulcer lesions, positive fecal occult blood that can not exclude gastrointestinal bleeding, intermittent haemoptysis) .\n13. Presence of significant gastrointestinal abnormalities during the screening period that may interfere with drug intake, transit or absorption (e.g. inability to swallow, chronic diarrhoea, post-small bowel resection or total gastrectomy), according to the investigator's judgment.\n14. History of gastrointestinal perforation and\u002For fistula, peptic ulcer disease, intestinal obstruction (including incomplete intestinal obstruction that requires parenteral nutrition), or biliary obstruction within 6 months prior to the first dose.\n15. History of other malignant tumors within 3 years prior to the first dose, except for those treated with expected curative outcomes, such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer, and papillary thyroid microcarcinoma.\n16. For urine protein≥2+ by urinalysis during the screening period, a 24-hour urine protein quantification test should be performed. The subject cannot be enrolled if the quantified urine protein is≥1g\u002F24h. If the quantified urine protein is \\\u003C1g\u002F24h, the subject can still be enrolled.\n17. Known severe hypersensitivity to any monoclonal antibody. Known hypersensitivity to Chiauranib capsules or any of its components. Known contraindications to albumin-paclitaxel and gemcitabine chemotherapy (refer to descriptions for albumin-paclitaxel and gemcitabine).\n18. Presence of active tuberculosis during the screening period. Suspected subjects should be excluded by a combination of chest imaging, sputum, and through clinical signs and symptoms.\n19. Presence of active hepatitis, positive HBsAg or positive HBcAb must undergo further HBV-DNA testing, enrollment is permitted only if the results meet either of the following criteria: within the normal range of the investigational site or \\\u003C200 IU\u002FmL. Positive HCV-Ab with positive viral replication. Positive of HIV. Active syphilis infection (syphilis-specific antibody and nonspecific antibody positive). (Note: Priority for qualitative detection and quantitative detection of viral replication when needed).\n20. Previous or screening chest imaging showing the presence of interstitial lung disease or pulmonary fibrosis or non-infectious pneumonitis requiring treatment.\n21. Active infection during the screening period, including systemic anti-infective therapy requiring oral or intravenous infusion within 2 weeks prior to the first dose, unexplained fever (≥38°C) during the screening period.\n22. Screening period or history of allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation.\n23. Unexplained weight loss of 5% or more between signing the ICF and the first dose.\n24. NRS pain score ≥4 after analgesic medication during the screening period.\n25. Severe central nervous system or psychiatric illness during the screening period.\n26. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion: vitiligo, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy, celiac disease controlled by diet alone, type I diabetes with good glycaemic control.\n27. Received corticosteroid medication within 14 days before the first dose(exceed 10 mg\u002Fday of prednisone or its equivalent) or other immunosuppressive drugs. The following are exceptions to this criterion: intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), corticosteroids as prophylaxis for allergic reactions (e.g. before imaging or chemotherapy), adrenal steroid replacement(not to exceed 10 mg\u002Fday of prednisone or its equivalent).\n28. Administration of a live attenuated vaccine within 28 days prior to the first dose. Live vaccines include but are not limited to: measles, epidemic parotitis, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin, typhoid fever vaccines. Injectable inactivated seasonal influenza vaccines are allowed, but intranasal live attenuated influenza, vaccines are not allowed.\n29. Pregnant or lactating females. Female participants of childbearing potential or male subjects whose partners of childbearing potential are unable or unwilling to use effective contraception (e.g., IUDs, subcutaneous implant, sterilisation, long-acting contraceptive injections, compound of short-acting oral contraceptives, etc.) from 7 days prior to the first dose until 6 months after the end of treatment. Female participants of childbearing potential must have a blood pregnancy test negative within 7days prior to the first dose. Note: Females with fertility include those who have experienced menarche and have not undergone successful artificial sterilization procedures (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have not reached menopause.\n30. During the screening period, the investigator deems other conditions unsuitable for participation in this trial, such as clinically unacceptable worsening symptoms or signs of pancreatic cancer progression, comorbidities, concurrent treatments, or any laboratory abnormalities that may interfere with the assessment of efficacy and safety outcomes.",{"count":364,"type":20},558,[24],"This is a phase III, multi-center study to evaluate the efficacy and safety of chiauranib plus plus toripalimab, albumin-paclitaxel and gemcitabine as first-line therapy in patients with metastatic pancreatic ductal adenocarcinoma. The study includes two period: Run-in period and Randomized controlled period. The Run-in period is a single-arm, open-label study enrolling approximately 20 participants, who received the combination therapy of chiauranib plus toripalimab, albumin-paclitaxel and gemcitabine. The Randomized controlled period is a randomized, double-blind, parallel-controlled study enrolling approximately 538 participants, who are 1:1 randomly assigned to the experimental arm(chiauranib plus Toripalimab, albumin-paclitaxel and gemcitabine) or the control arm (Chiauranib placebo plus toripalimab placebo, albumin-paclitaxel and gemcitabine).",[28],"2026-02-28",{"date":370,"type":42},"2026-03-03",{"date":372,"type":20},"2026-03-31",{"date":374,"type":20},"2028-11-30",{"name":376,"class":49},"Chipscreen Biosciences, Ltd.",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":155},"100362937","early-phase-1-targeted-pathway-inhibition-in-patients-with-pancreatic-cancer-100362937","NCT04005690","Targeted Pathway Inhibition in Patients With Pancreatic Cancer","A Window of Opportunity Strategy for Targeted Pathway Inhibition in Patients With Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Clinically-confirmed diagnosis of resectable, borderline resectable, locally-advanced or metastatic adenocarcinoma of the pancreas.\n\n  * Patients with disease that is eligible for curative surgery may not be eligible for all study arms.\n  * Participants may be treatment naïve or have received prior therapy for the treatment of their pancreatic ductal adenocarcinoma (PDAC). A minimum washout period of 10-days after completing the most recent line of therapy is required before a participant can initiate treatment with study agent(s)\n* Based on available imaging, participant must have at least one disease lesion that can be biopsied in accordance with institutional standards\n* Hemoglobin \\>= 9.0 g\u002FdL with no blood transfusion within 28 days of starting treatment (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (\\> 1500 per mm\\^3) (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion.\n\n  * May be waived on a case-by-case basis for patient populations recognized to have normal baseline values below this level\n* Platelet count \\>= 100 x 10\\^9\u002FL (\\> 100,000 per mm\\^3) (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN), OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) \\>= 60 mL\u002Fmin\u002F1.73m\\^2 for participants with creatinine levels \\> 1.5 x institutional ULN (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion.\n\n  * Creatinine clearance should be calculated per institutional standard. For participants with a baseline calculated creatinine clearance below normal institutional laboratory values, a measured baseline creatinine clearance should be determined. Individuals with higher values felt to be consistent with inborn errors of metabolism will be considered on a case-by-case basis\n* Serum bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN (within 4 weeks prior to initiating window treatment). Note: laboratory tests performed after initial screening (but still within the screening window) will be evaluated by the investigator; should any of these values fall outside eligibility parameters, the patient may still be eligible per investigator discretion\n* Participants must be willing to undergo mandatory on-study tumor biopsies\n* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Participant must be able to swallow tablets or capsules. A participant with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible\n* Participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Participants must agree to use an adequate method of contraception starting with the first dose of study therapy and for the required length of time ascribed to the assigned study drug assignment\n* No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer, any malignancy treated with a curative intent without evidence of disease recurrence for at least 6 months\n* Individuals must not have known active hepatitis B virus (HBV). Those who have completed curative therapy for hepatitis C virus (HCV) are eligible. HCV infection permitted but patient must be Child's Pugh A. Patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following 3 criteria:\n\n  * CD4 counts \\>= 350 mm\\^3\n  * Serum HIV viral load of \\\u003C 25,000 IU\u002Fml and\n  * Treated on a stable antiretroviral regimen\n  * Note: HIV testing is not required at screening, unless if required by local regulations, where the testing will be done by local laboratory\n* AZENOSERTIB SPECIFIC CRITERIA: Those with prior treatment with a WEE1 inhibitor are not eligible\n* AZENOSERTIB SPECIFIC CRITERIA: Patients are not eligible if any of the following treatment interventions have occurred within the specified time frame(s) prior to starting study intervention:\n\n  * Major surgery within 28 days (the surgical incision should be fully healed prior to study drug administration)\n  * Radiation therapy within 21 days; however, if the radiation portal covered ≤ 5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiotherapy\n  * Autologous or allogeneic stem cell transplant within 3 months\n  * Current use of an investigational agent that is not expected to be cleared by the first dosing of study drug or that has demonstrated to have prolonged side effects\n  * Prescription, non-prescription drugs or food known as moderate to strong inducers of CYP3A within 2 weeks\n* AZENOSERTIB SPECIFIC CRITERIA: Patients are not eligible if there is a serious illness or medical condition(s) including, but not limited to, the following:\n\n  * Symptomatic brain metastases\n  * Leptomeningeal disease that requires or is anticipated to require immediate treatment.\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the subject inappropriate for entry into this study\n  * Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption\n  * Active or uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥ 72 hours\n* AZENOSERTIB SPECIFIC CRITERIA: 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \\>480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid\n* AZENOSERTIB SPECIFIC CRITERIA: History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes\n* AZENOSERTIB SPECIFIC CRITERIA: Patients are not eligible in cases of unresolved toxicity of grade \\> 1 attributed to any prior therapies (excluding grade 2 neuropathy, alopecia or skin pigmentation)\n* AZENOSERTIB SPECIFIC CRITERIA: Patients are not eligible if there is known hypersensitivity to any drugs similar to ZN-c3 in class\n* AZENOSERTIB SPECIFIC CRITERIA: Individuals that are pregnant or breast-feeding are not eligible\n* AZENOSERTIB SPECIFIC CRITERIA: Participants must agree to use an adequate method of contraception as follows:\n\n  * Participants of childbearing potential agree to use adequate methods of contraception for the duration of study participation.\n  * Sperm-producing participants must agree to refrain from sperm donation during the study and for 30 days after the last dose of study drug\n* AZENOSERTIB SPECIFIC CRITERIA: Participant requiring any medications that can lead to significant QT prolongation are not eligible\n* AZENOSERTIB SPECIFIC CRITERIA: Participant requires administration of strong and moderate CYP3A4 inhibitors and inducers as well as strong and moderate P-glycoprotein (P-gp) inhibitors are not eligible\n* AZENOSERTIB SPECIFIC CRITERIA: Due to potential CYP3A4 interaction with the study medication, participants are asked to refrain from consumption of seville oranges, grapefruit or grapefruit juice, ppomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices) from 7 days prior to the initiating study agent and during the entire study. NOTE: Orange juice is permitted\n* AZD5305 SPECIFIC CRITERIA: Participants must agree to use an adequate method of contraception as follows:\n\n  * Participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through at least 6 months after the last dose of study therapy\n  * Sperm-producing participants must use a condom during treatment and for 6 months after the last dose of AZD5305 when having sexual intercourse with an individual that is pregnant or of childbearing potential. Individuals that are partners of sperm-producing participants should also use a highly effective form of contraception if they are of childbearing potential\n* TREMELIMUMAB SPECIFIC CRITERIA: Participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through at least 3 months after the last dose of study therapy\n\nExclusion Criteria:\n\n* Tumor not accessible for core biopsy\n* Medical co-morbidities that are deemed to make risk of surgery unacceptably high as determined by institutional standards\n* Recent major surgery within 4 weeks prior to starting study treatment. Minor surgery within 2 weeks of starting study treatment. Patients must be recovered from effects of surgery\n* Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil)\n* Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil)\n* Concomitant use of other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy or other novel agent) or live virus and live bacterial vaccines while the patient is receiving study medication. Strong or moderate CYP3A inhibitors and inducers should not be taken with study treatment; however, if no other suitable alternative concomitant medication is available, dose reductions may be allowed under careful monitoring\n* Known severe hypersensitivity to the study agent(s) (or equivalent agents, respectively), or any excipient of these medicinal products, or history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent(s)\n* Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n  * Clinically significant and\u002For uncontrolled heart disease such as congestive heart failure (New York Heart Association grade \\>= 2) uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment\n  * Corrected QT using Fridericia's formula (QTcF) \\> 470 msec for females, or \\> 450 msec for males, on screening electrocardiogram (ECG) or congenital long QT syndrome\n  * Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to screening\n* Clinically significant cardiac disease or impaired cardiac function\n* Female participant who is pregnant or lactating\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally\n* Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment)\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Participants with a history of hypersensitivity reactions to study agents or their excipients\n* Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through at least 120 days after the last dose of trial treatment\n* AZD5305 SPECIFIC CRITERIA: Known allergy or hypersensitivity to AZD5305 or any of its excipients\n* AZD5305 SPECIFIC CRITERIA: Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML\n* AZD5305 SPECIFIC CRITERIA: Cardiovascular disease, QTc \\> 450 ms, or any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n* AZD5305 SPECIFIC CRITERIA: History of persisting (\\> 2 weeks) severe pancytopenia due to any cause (ANC \\\u003C 0.5 x 10\\^9\u002FL or platelets \\\u003C 50 x 10\\^9\u002FL)\n* TREMELIMUMAB SPECIFIC CRITERIA: Medical co-morbidities that are deemed to make risk of surgery unacceptably high as determined by institutional standards\n* TREMELIMUMAB SPECIFIC CRITERIA: Participants have received prior immunotherapy for the treatment of their PDAC\n* TREMELIMUMAB SPECIFIC CRITERIA: Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) \\> grade 2 from prior neoadjuvant therapy\n* TREMELIMUMAB SPECIFIC CRITERIA: History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, interstitial lung disease (ILD), pleural effusion, or pulmonary fibrosis diagnosed in the past 6 months prior to randomization\n* TREMELIMUMAB SPECIFIC CRITERIA: Active or prior documented autoimmune or inflammatory disorders",{"count":385,"type":20},90,[321],"This early phase I trial aims to determine how cobimetinib, olaparib, onvansertib, azenosertib, AZD5305 or tremelimumab works in patients with pancreatic cancer. Validation of cobimetinib, olaparib, onvansertib azenosertib, AZD5305 and tremelimumab molecular targets will be explored by comparing pre-treatment biopsies with post-treatment specimens. This knowledge will help design future biomarker driven trials to determine whether giving cobimetinib, or olaparib, or onvansertib or azenosertib, or AZD5305, or tremelimumab will work better than standard treatments in patients with pancreatic cancer.",[324,28,325,90,91,92,389,390],"Borderline Resectable Pancreatic Ductal Adenocarcinoma","Resectable Pancreatic Ductal Adenocarcinoma","2026-02-26",{"date":393,"type":42},"2026-02-27",{"date":395,"type":42},"2019-08-01",{"date":397,"type":20},"2028-02-01",{"name":334,"class":154},{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":429,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":461},"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":408,"type":20},24,[86],"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.",[412,413,414,415,291,265,416,28,417,418,419,420,421,422,423,424,425,426,427,428],"Pancreatic Adenocarcinoma Metastatic","BRCA1 Mutation","BRCA2 Mutation","Pancreatic Acinar Cell Carcinoma","Metastatic Pancreatic Cancer","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, Metastatic","Pancreas Cancer, Recurrent","Pancreas Cancer","Stage IV Pancreatic Cancer","Stage 4 Pancreatic Cancer",[430,30,431,432,433,434,435,436,437,438,439,440,441,442,443,63,444,445,446,447,448,449,450,451,452,453],"pancreatic adenocarcinoma","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",{"date":455,"type":42},"2026-01-29",{"date":457,"type":42},"2021-01-13",{"date":226,"type":20},{"name":460,"class":49},"General Oncology, Inc.",2,{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":470,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":155},"100591544","phase-1-phase-i-study-of-cosibelimab-and-balixafortide-in-metastatic-pancreatic-ductal-adenocarcinoma-100591544","NCT06981806","Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma","IIT2023-07-Osipov-CXCR4: Phase I Dose Escalation and Dose Expansion Study of Combination Immunotherapy With Cosibelimab and CXCR4 Inhibition With Balixafortide in Metastatic Treatment Refractory Pancreatic Ductal Adenocarcinoma","Inclusion Criteria\n\n* Patients must have histologically (cytology) confirmed pancreatic ductal adenocarcinoma (PDAC) that is metastatic or unresectable, with disease progression after standard of care (SOC) chemotherapy. Patients with clinical, radiologic, and\u002For pathologic evidence of metastatic disease after SOC chemotherapy are eligible.\n* Age 18 or older\n* ECOG Performance Status 0-2\n* Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* All patients must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for 120 days after the last dose of study treatment.\n* Participants who are HbsAg positive are eligible if they have undetectable HBV viral load prior to screening and have received HBV anti-viral therapy for at least 4 weeks prior to first dose of study treatment. Hepatitis B screening tests are not required unless the participant has a known history of HBV infection.\n* Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening and have completed curative anti-viral therapy at least 4 weeks prior to first dose of study treatment. Hepatitis C screening tests are not required unless the participant has a known history of HCV infection.\n* HIV-infected participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:\n\n  1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n  2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n  3. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study\n* Have adequate organ function as defined in the following table. Specimens must be collected within 3 days prior to the start of study intervention.\n\nSystem Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1000\u002FµL Platelets ≥75,000\u002Fµ Renal Creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN (Except patients with Gilbert syndrome, who may enroll as long as total bilirubin AST (SGOT) and ALT (SGPT) ≤3.0 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR Prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Creatinine clearance (CrCl) should be calculated per institutional standard\n\nExclusion Criteria\n\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Is currently participating in or has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n* Has severe hypersensitivity (≥Grade 3) or history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study: Cosibelimab and Balixafortide.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an uncontrolled, active infection requiring systemic treatment. Patients with an infection that is controlled with oral or IV anti-microbials (e.g., UTI with short term antibiotic course), adequate source control, and no evidence of worsening clinical status are eligible.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or planning to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has a history of any organ transplant (e.g., allogeneic stem cell transplant, solid organ transplant, corneal transplant)",{"count":408,"type":20},[86],"This is a single-center, open-label, phase 1 dose escalation and dose expansion (safety confirmation) trial to evaluate the safety and tolerability of balixafortide and cosibelimab in patients with metastatic PDAC who progressed after SOC chemotherapy.",[28],[474,475,476],"Chemotherapy","Cosibelimab","Balixafortide","2025-11-17",{"date":479,"type":42},"2025-11-19",{"date":481,"type":20},"2026-01",{"date":483,"type":20},"2027-02",{"name":485,"class":154},"Arsen Osipov",{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":495,"phases":4,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":155},"100562264","hyperpolarized-13c-mri-to-predict-response-in-pancreatic-cancer-100562264","NCT06600906","Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer","Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer","Inclusion Criteria:\n\n* Participants must be 18 years or older.\n* Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA).\n* Locally advanced or metastatic disease.\n* At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%)\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.\n* Poorly controlled hypertension, defined as either systolic \\> 170 or diastolic \\> 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.\n* Congestive Heart Failure ≥ Class III.\n* Participants who are pregnant.\n* Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (\\>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n* Participants who are breastfeeding\u002Fchestfeeding. Breastfeeding\u002Fchestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding\u002Fchestfeeding should be discontinued before administration of HP 13C pyruvate.\n* Known hypersensitivity to HP 13C pyruvate or any of its excipients.\n* Participants with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures",{"count":494,"type":20},70,"OBSERVATIONAL","This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.",[291,28,324],"2025-11-07",{"date":500,"type":42},"2025-11-12",{"date":502,"type":42},"2024-10-01",{"date":504,"type":20},"2032-09-01",{"name":506,"class":154},"University of California, San Francisco",{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":21,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":155},"100600351","phase-2-utility-of-ctdna-in-early-switch-of-first-line-mfolfirinox-in-metastatic-pancreatic-ductal-adenocarcinoma-100600351","NCT07096362","Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma","A Phase 2 Study Assessing Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n1. Histologically confirmed, metastatic pancreatic adenocarcinoma. Patients with adenosquamous carcinoma and mixed adenocarcinoma\u002Fneuroendocrine carcinoma (MANEC) of the pancreas are eligible, but pure neuroendocrine neoplasms are excluded.\n2. Treatment-naïve patients diagnosed with metastatic pancreatic adenocarcinoma.\n3. Must have a detectable circulating tumor deoxyribonucleic acid (DNA) at cycle 1 day 1.\n4. Patients must have a detectable circulating tumor deoxyribonucleic acid (ctDNA) quantity on Northstar Response assay at baseline.\n5. At least one tumor measurable by Computed Tomography (CT) scan or Positron Emission Tomography-Computed Tomography (PET\u002FCT) scan. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>20 mm with conventional techniques or \\>10 mm with spiral CT scan.\n6. Adult male and female participants (≥ 18 years of age).\n7. Male or non-pregnant and non-lactating female. Men and women with intact reproductive potential must agree to use contraception.\n8. Adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:\n\n   * Absolute neutrophil count (ANC) ≥ 1.0 × 109 cells\u002FL.\n   * Platelet count ≥ 100,000 cells\u002Fmm3 (100 × 109 cells\u002FL). Supportive platelet transfusions are acceptable.\n   * Hemoglobin (Hgb) ≥ 9 g\u002FdL. Supportive packed red blood cell transfusions are acceptable.\n9. Adequate blood chemistry levels at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:\n\n   * Aspartate aminotransferase (AST) - serum glutamic-oxaloacetic transaminase (SGOT); alanine transaminase (ALT) - serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 × upper limit of normal (ULN) range, unless liver metastases are present, then ≤ 5 × ULN is allowed.\n   * Total bilirubin ≤ 1.5 × Upper Limit of Normal.\n   * Estimated creatinine clearance of \\> 60 mL\u002Fmin (per Cockcroft-Gault formula).\n   * Albumin ≥ 3.0 g\u002FdL.\n10. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to ≤ 1.\n11. Must be a modified Folfirinox chemotherapy candidate.\n12. For participants not qualified or able to give legal consent, consent must be obtained from their legally authorized representative (LAR).\n\nExclusion Criteria:\n\n1. Patients with pure neuroendocrine neoplasms of the pancreas.\n2. Brain metastases.\n3. Uncontrolled ascites.\n4. Increase of ECOG to \\> 1 between screening and enrollment.\n5. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.\n6. History of untreated or uncontrolled HIV and\u002For Hepatitis B or C infection.\n7. Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n   * History of myocardial infarction, angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within six months prior to study entry\n   * Documented cardiomyopathy\n8. Grade 2 or greater sensory peripheral neuropathy.\n9. History of chronic diarrhea.\n10. Pregnant or nursing.\n11. Concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or integrity of the study data.\n12. Concurrently enrolled in any other interventional clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer.\n13. Patient is unwilling or unable to comply with study procedures.\n14. Patients with impaired decision-making capacity.\n15. No other medical condition or reason that, in the opinion of the investigator, would preclude study participation.",{"count":515,"type":20},50,[23],"The purpose of this study is to understand whether a blood-based test called circulating tumor DNA (ctDNA) can detect whether participants are having a desired tumor shrinkage or an undesired lack of tumor shrinkage, and to study whether these levels of ctDNA can be used to make treatment decisions faster than the current standard approach, which is to wait 8 weeks after starting chemotherapy to obtain participant first imaging scans since starting chemotherapy.",[28,291],"2025-09-17",{"date":521,"type":42},"2025-09-23",{"date":523,"type":42},"2025-09-09",{"date":525,"type":20},"2030-09-30",{"name":527,"class":154},"University of Miami",{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":21,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":155},"100580918","phase-2-the-miami-empire-trial---eradication-of-metastatic-pancreatic-cancer-with-immuno-radiation-100580918","NCT06843551","The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation","A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation","EMPIRE","Inclusion Criteria:\n\n1. ≥18 years old\n2. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.\n3. Microsatellite stable (MSS) disease by pathologic assessment.\n4. Patients must have measurable disease as defined by RECIST 1.1.\n5. Progression on ≥1 line of systemic therapy.\n6. No concomitant therapy with any of the following: interleukin (IL)-2, interferon, non study immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, other investigational therapies, and\u002For chronic use of systemic corticosteroids.\n7. No known infection with human immunodeficiency virus (HIV) or active infection with Hepatitis B.\n8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n9. Life expectancy ≥3 months.\n10. Patients must have the following lab values obtained \\\u003C4 weeks prior to starting protocol treatment:\n\n    1. absolute neutrophil count (ANC) ≥1,000 cells\u002FμL\n    2. white blood count (WBC) ≥2,000 cells\u002FμL\n    3. platelets ≥75,000 per μL\n    4. hemoglobin ≥8.0 g\u002FdL\n    5. creatinine clearance ≥40 mL\u002Fmin)\n    6. serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN)\n    7. aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 × ULN (or ≤5 × ULN in patients with liver metastases)\n    8. international normalized ratio or prothrombin time ≤1.5 × ULN\n    9. activated partial thromboplastin time ≤2.5 × ULN\n    10. absolute lymphocyte count (ALC) ≥1000 cells\u002FμL at baseline\n11. At least 1 previously unirradiated lesion amenable to pre-treatment biopsy.\n12. No limit on overall numbers of lesions, but liver tumor burden ≤25% of total liver volume.\n13. Women of childbearing potential (WOCBP): negative serum pregnancy test (within 7 days prior to Day 1 of protocol therapy)\n\n    a. Females of non-childbearing potential are defined as: i. ≥ 50 years of age and has not had menses for greater than 1 year ii. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation iii. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.\n14. Male and female patients of reproductive potential must use effective methods of contraception or abstain from sexual activity for the course of the study through at least 6 months after the last dose of balstilimab and\u002For botensilimab. See Section 4.11, Contraception.\n\nExclusion Criteria:\n\n1. Liver tumor burden exceeding 25% of total liver volume.\n2. Active, untreated central nervous system (CNS) metastases.\n3. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n4. Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n5. Previous external beam radiation therapy to the liver or radioisotope therapy directed to the liver or any liver embolization.\n6. Clinically significant ascites requiring a paracentesis in the last 4 weeks, or clinically significant history of liver failure defined as any prior episode of hepatic encephalopathy and\u002For any prior history of an elevated serum ammonia level.\n7. Partial or complete bowel obstruction within the last 3 months prior to study enrollment, signs\u002Fsymptoms of bowel obstruction, or known radiologic evidence of impending obstruction.\n8. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of study enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n\n   a. QT interval corrected using Fridericia's formula (QTcF) of \\> 480 ms.\n9. Prior allogeneic organ transplantation.\n10. Treatment with chemotherapy or targeted therapy within 2 weeks prior to initiating EMPIRE treatment.\n11. Persistent grade ≥2 adverse events (aEs) from prior therapy (except neuropathy).\n12. Known additional malignancy requiring active treatment.\n13. History of non-infectious pneumonitis.\n14. Active infection requiring antibiotic.\n15. Live vaccine within 30 days of protocol treatment.\n16. Severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) (SARS-CoV-2) vaccine or booster \\\u003C 7 days before Cycle 1 Day 1 (C1D1). For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \\> 7 days from C1D1 or \\> 7 days from future cycle on study.\n17. History of severe hypersensitivity reaction to monoclonal antibody.\n18. Participants with impaired decision-making capacity.",{"count":5,"type":20},[23],"The purpose of this study is to assess if radiation therapy (which uses high-energy radiation to damage or destroy cancer cells) combined with immune checkpoint inhibitors (medications that helps the body recognize and attack cancer cells) will be beneficial for patients with metastatic pancreatic ductal adenocarcinoma.",[28,416],"2025-08-12",{"date":542,"type":42},"2025-08-14",{"date":544,"type":42},"2025-06-18",{"date":546,"type":20},"2030-08-01",{"name":548,"class":154},"Benjamin Spieler",{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":21,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":568,"locationsCount":133},"100475540","phase-2-a-study-evaluating-the-efficacy-of-5-fu--naliri-and-5-fu--nalirinox-for-pdac-nalpac-100475540","NCT05472259","A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)","A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy","NALPAC","Inclusion Criteria:\n\n* Histologically proven metastatic adenocarcinoma of the pancreas\n* Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy\n* Signed written informed consent\n* Age ≥ 18\n* ECOG PS 0\u002F1 at study entry\n* Measurable disease\n* Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109\u002FL, platelets ≥ 100x109\u002FL, hemoglobin ≥ 9g\u002Fdl)\n* INR\u002FPTT ≤ 1.5x ULN\n* Life expectancy of at least 12 weeks\n* Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration\n* Peripheral Neuropathy \\\u003C grade 2\n\nExclusion Criteria:\n\n* Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension\n* History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months\n* Known hypersensitivity to any of the components, including excipients, of study treatments\n* Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type\n* Pregnancy or breast feeding\n* Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent\n* Unstable angina, congestive heart failure ≥NYHA class II\n* Uncontrolled hypertension despite optimal management (systolic blood pressure \\>150 mmHg or diastolic pressure \\> 90mmHg)\n* HIV infection\n* Complete DPD deficiency\n* Liver failure, cirrhosis Child Pugh B or C\n* Active chronic hepatitis B or C with a need for antiviral treatment\n* Brain metastasis\n* Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment\n* History of organ allograft\n* Ongoing uncontrolled, serious infection\n* Renal failure requiring dialysis\n* Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study",{"count":558,"type":20},134,[23],"A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy",[28],"2025-02-04",{"date":564,"type":42},"2025-02-06",{"date":566,"type":42},"2022-05-25",{"date":332,"type":20},{"name":569,"class":154},"Belgian Group of Digestive Oncology"]