[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-pancreatic-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-pancreatic-adenocarcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,70,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100467887","phase-1-testing-the-safety-and-tolerability-of-the-anti-cancer-drugs-trastuzumab-deruxtecan-and-neratinib-for-cancers-with-changes-in-the-her2-gene-100467887",false,"NCT05372614","Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene","Phase I Trial of DS-8201a (Trastuzumab Deruxtecan) in Combination With Neratinib in Solid Tumors With HER2 Alterations","Inclusion Criteria:\n\n* Patients must have histologically confirmed malignancy that is metastatic or unresectable with participation in this clinical trial determined to be the best option for next treatment in the opinion of the investigator, and meet the following specific criteria:\n\n  * Patients enrolling in Part 1 (Dose Escalation) may have a diagnosis of any solid tumor\n  * Patients enrolling in the Part 2 Pharmacodynamic Cohort may have a diagnosis of any solid tumor except pancreas cancer (NOTE: pancreatic cancer excluded from this cohort after Revision 11 activation due to the addition of the pancreatic specific cohort)\n  * Patients enrolling in the Part 2 Pancreatic Cohort must have a diagnosis of pancreatic adenocarcinoma (PDAC) and meet the HER2 positivity guidance\n* Patients must have a solid tumor with HER2-positivity as determined by any one or more of the following:\n\n  * HER2 overexpression defined by immunohistochemistry (IHC) 3+\n  * ERBB2 amplification by in situ hybridization (ISH) or next-generation sequencing as determined by any Clinical Laboratory Improvement Act (CLIA) certified lab\n  * A known HER2 activating mutation\n  * HER2 overexpression by IHC\u002FISH will follow histology specific American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines for breast and gastric cancers. HER2 overexpression by IHC\u002FISH for the Pancreatic Cohort will follow ASCO-CAP guidelines for gastric cancers. For tumor histologies without specific guidelines the following criteria will apply:\n\n    * HER2 IHC should be performed first, followed by ISH methods in cases showing 2+ (equivocal) expression by IHC. Positive (IHC 3+) or negative (IHC 0 or 1+) do not require further ISH testing. Cases with HER2:CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals per cell are considered positive by ISH\n  * Known HER2 activating mutations:\n\n    * G309A\u002FE\n    * S310F\u002FY\n    * S653C\n    * V659E\n    * G660D\n    * R678Q\n    * E693K\n    * Q709L\n    * L755S\u002FP\n    * Del. 755-759\n    * D769Y\u002FH\n    * G776V\u002FC\n    * V777L\n    * V842I\n    * T862A\n    * L869R\n    * H878Y\n    * All exon 20 insertions, including:\n\n      * A771\\_Y772insYVMA\n      * A775\\_G776insYVMA\n      * Y772\\_A775dup\n      * P780\\_Y781insGSP\n      * G778\\_P780dup\n    * V697L\n    * T733I\n    * D769N\n    * L841V\n    * L866M\n    * R896C\n  * If a different mutation is identified, contact the study chair for conferral. Synonymous mutations are not eligible\n* Patients must have received at least 1 prior line of therapy in the advanced\u002Fmetastatic setting. No limitation on number of prior therapies; however, patients may not have received neratinib or DS-8201a previously. Prior HER2-targeted therapy other than neratinib or DS-8201a is allowed (e.g., trastuzumab, pertuzumab, TDM-1, lapatinib, etc.)\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of neratinib in combination with DS-8201a in patients \\\u003C 18 years of age, children are excluded from this study\n* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%)\n* Hemoglobin \\>= 9.0 g\u002FdL (\\>= 8.0 g\u002FdL for gastric cancer \\[GC\\] only) (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 \\>= 3.0 K\u002Fcumm (within 14 days of enrollment)\n* Absolute neutrophil count \\>= 1.5 K\u002Fcumm (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 K\u002Fcumm (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* Serum albumin \\>= 2.5 g\u002FdL (within 14 days of enrollment)\n* Total bilirubin =\\\u003C 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\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x ULN (if liver metastases are present =\\\u003C 5 x ULN) (within 14 days of enrollment)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x institutional ULN (within 14 days of enrollment)\n\n  * This applies only to patients who are not receiving therapeutic anticoagulation that may affect INR. Those who are on therapeutic anticoagulation, should be on a stable dose for 4 weeks and should be considered within therapeutic range\n* Creatinine =\\\u003C 1.5 x institutional ULN OR Glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 (using the Cockcroft-Gault equation) (within 14 days of enrollment)\n* Patients who are human immunodeficiency virus (HIV)-positive may participate IF they meet the following eligibility requirements:\n\n  * They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective\n  * They must have a CD4 count of greater than 250 cells\u002FmcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\\u003C 200 cells\u002Ful over the past 2 years, unless it was deemed related to THE CANCER AND\u002FOR CHEMOTHERAPY-induced bone marrow suppression\n\n    * For patients who have received chemotherapy in the past 6 months, a CD4 count \\\u003C 250 cells\u002Ful during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy\n  * They must have an undetectable viral load and a CD4 count \\>= 250 cells\u002FuL within 7 days of enrollment\n  * They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months.\n\nHIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts\n\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 the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and 2) the patient no longer requires steroids, or is on a stable steroid dose \\> 4 weeks\n* Patients with radiographically new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible only if has no progressive clinical symptoms and if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients should be New York Heart Association functional classification of class 2B or better\n* Patients must have left ventricular ejection fraction (LVEF) \\>= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization\u002Fenrollment\n* Part 2, Pancreatic cohort ONLY: Patients must have disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Part 2, PD cohort ONLY: Patients must have disease that is evaluable or measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Part 2, PD cohort ONLY: Patients must have at least one lesion suitable for biopsy without significant risk to the patient. The biopsiable lesion can be the same as the evaluable lesion for response by RECIST 1.1\n* HER2 antibody conjugated to a topoisomerase 1 inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic; thus, women of child-bearing potential 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 at least 1 month after the last dose of neratinib, or at least 7 months after the last dose of DS-8201a, whichever is longer (women of childbearing potential \\[WOCBP\\] only). 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after the last dose of neratinib, or 4 months after completion of DS-8021a administration, whichever is longer\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 enrollment 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. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible\n\nExclusion Criteria:\n\n* With the exception of medications that are under investigation in the study (e.g., standard of care, comparators, or combination therapies), the following medications, treatment, and procedures will be prohibited during the treatment period:\n\n  * Other anticancer therapy, including small-molecule targeted agents within 2 weeks or five half-lives, whichever is longer; chemotherapy otherwise not specified (including, but not limited to cytotoxic chemotherapy, antibody drug conjugates, retinoid therapy, hormonal therapy) within 3 weeks; immunotherapy or monoclonal antibody within 4 weeks; and nitrosoureas or mitomycin C within 6 weeks (concurrent use of hormones for noncancer-related conditions \\[e.g., insulin for diabetes and hormone replacement therapy\\] is acceptable)\n  * Other investigational therapeutic agents\n  * Patients who have had major surgery or radiation within 4 weeks; palliative stereotactic radiation within 2 weeks (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section)\n  * Radiotherapy to the thorax (palliative radiation to known metastatic sites in the thoracic spine is permitted in this study)\n  * Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing adverse events (inhaled steroids or intra-articular steroid injections are permitted in this study); chronic replacement dose steroids (e.g., for those with adrenal insufficiency) are permitted in this study\n  * Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study\n  * Concomitant treatment with chloroquine or hydroxychloroquine is not allowed during the study treatment due to concern for overlapping toxicities. If treatment with chloroquine and hydroxychloroquine treatment is absolutely required, study treatment must be interrupted. If chloroquine or hydroxychloroquine is administered, then a wash-out period of more than 14 days is required before restarting study treatment\n  * Receipt of live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study drug\n* Patients with a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e. rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy\n* Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to DS-8201a, the inactive ingredients in the drug product, or neratinib\n* Patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies\n* Patients receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A4 and P-glycoprotein are ineligible. Avoid concomitant use with proton pump inhibitors and P-glycoprotein substrates. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with a medical history of myocardial infarction within 6 months before enrollment, or symptomatic congestive heart failure (CHF) (New York Heart Association class II to IV)\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 clinically significant corneal disease in the opinion of the investigator\n* Patients with a pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART). (Drainage and CART are not allowed within 2 weeks prior to screening assessment) (GC indication)\n* Patients with spinal cord compression\n* Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade =\\\u003C 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)\n* Patients with substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results\n* Pregnant women are excluded from this study because DS-8201a is a HER2 antibody conjugated to a topoisomerase 1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with DS-8201a, breastfeeding should be discontinued if the mother is treated with DS-8201a. These potential risks may also apply to other agents used in this study\n* Prior treatment with neratinib or DS-8201a\n* Clinically significant chronic gastrointestinal disorder with diarrhea as a major symptom; grade 2 (G2) or greater diarrhea at baseline. Please contact the study principal investigator (PI) for any patient with more than two episodes of diarrhea per day averaged over at least a 7 day period at time of screening to determine whether the diarrhea would be considered clinically significant\n* Inability to swallow tablets\n* Patients with active additional malignancy or a personal history of additional malignancy that may affect outcome of disease under treatment (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 at the discretion of the treating investigator are allowed)\n* Patients with prior allogeneic organ transplantation including allogeneic stem cell transplantation","ALL","18 Years",{"count":19,"type":20},58,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of neratinib in combination with trastuzumab deruxtecan in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable), and have changes in a gene called human epidermal growth factor receptor 2 (HER2). Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Trastuzumab deruxtecan 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 tumor cells in a targeted way and delivers deruxtecan to kill them. Adding neratinib to trastuzumab deruxtecan may be able to shrink cancer with a change in the HER2 gene.",[26,27,28,29,30,31],"Metastatic Malignant Solid Neoplasm","Metastatic Pancreatic Adenocarcinoma","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Unresectable Malignant Solid Neoplasm","Unresectable Pancreatic Adenocarcinoma","RECRUITING","2026-08-05",{"date":35,"type":36},"2026-08-06","ACTUAL",{"date":38,"type":36},"2022-10-05",{"date":40,"type":20},"2028-07-17",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",18,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100607487","phase-1-tr-002-for-the-treatment-of-advanced-unresectable-metastatic-solid-tumors-unresectable-or-metastatic-refractory-pancreatic-adenocarcinoma-100607487","NCT07189195","TR-002 for the Treatment of Advanced Unresectable Metastatic Solid Tumors Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma","A Phase 1 Study of Bisaminoquinoline Derivative (TR-002) for Injection for Advanced Treatment-Refractory Solid Tumors","Inclusion Criteria:\n\n* Aged 18 or over at the time of consent\n* Pathology or histology-confirmed metastatic or unresectable solid tumor for which standard systemic treatments are no longer effective or not tolerated\n* For the expansion cohort, participants must have pathology or histology-confirmed metastatic or unresectable pancreatic adenocarcinoma that is refractory and\u002For intolerant to all standard-of-care systemic treatments (including gemcitabine, nab-paclitaxel, fluoropyrimidine, oxaliplatin, and irinotecan)\n* Participants in dose escalation may have measurable and\u002For non-measurable disease. Imaging for disease assessment of measurable and non-measurable disease must be completed within 28 days prior to registration. Participants in dose expansion must have measurable disease per Response Evaluation Criteira in Solid Tumors (RECIST) 1.1\n* Adequate cardiac function, assessed by multiple-gated acquisition (MUGA) scan or echocardiography (left ventricular ejection fraction of \\> 50%)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 75,000\u002FmcL\n* Hemoglobin ≥ 8g\u002FdL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (\\\u003C 3 x ULN in patients with known Gilberts)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN (\\\u003C 5 x ULN in patients with known liver metastases)\n* Creatinine ≤ 1.5 x institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* For people of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method through 3 months following the last dose of study treatment\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Lactating or pregnant patients or patients of reproductive potential not willing to use effective methods of contraception\n* Clinically significant toxicities from most recent therapy or intervention prior to study enrollment that have not resolved to baseline or grade 1 (exceptions include alopecia and grade 2 sensory neuropathy)\n* Participant with a history of the following significant cardiovascular disease will be excluded:\n\n  * Participant has a history of myocardial infarction or unstable angina within 6 months prior to day 1.\n  * Participant has New York Heart Association (NYHA) Class II or greater congetive heart failure (CHF).\n  * History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study treatment.\n  * Participant has cardiac arrhythmia, complete left bundle branch block, obligate use of a cardiac pacemaker, long QT syndrome or right bundle branch block with left anterior hemiblock (bifascicular block).\n  * History of congenital long QT syndrome or prolonged corrected QT interval (QTc) \\> 470 msec for females and males using Fridericia's formula (unless a pacemaker is in place or additional clinically non-significant condition such as bundle-branch block necessitating use of an alternate formula per cardiologist calculation) or uncorrectable abnormalities in serum electrolytes (i.e., sodium, potassium, calcium, magnesium, phosphorus). An average of triplicate readings for assessing QTc interval may be used\n* Active bacterial, fungal, and viral infection, as documented by positive culture, radiological imaging techniques, septic fever, or septic shock symptoms\n* Known hypersensitivity to 4-aminoquinolone compounds\n* Retinal or visual field changes of any etiology\n* History of psoriasis\n* History of porphyria\n* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* History of seizure disorder\n* Any other condition that could compromise the subject's safety or put the study outcomes at undue risk",{"count":53,"type":20},52,[23],"This phase I trial tests the safety, side effects and best dose of TR-002 for the treatment of solid tumors 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), that has spread from where it first started (primary site) to other places in the body (metastatic) and unresectable or metastatic pancreatic adenocarcinoma that does not respond to treatment (refractory). Chemotherapy drugs, such as TR-002, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. TR-002 may be safe and tolerable in treating patients with advanced, unresectable or metastatic solid tumors and unresectable or metastatic, refractory pancreatic adenocarcinoma.",[57,26,27,58,28,29,30,31],"Advanced Malignant Solid Neoplasm","Refractory Pancreatic Adenocarcinoma","2026-07-14",{"date":61,"type":36},"2026-07-16",{"date":63,"type":36},"2025-11-07",{"date":65,"type":20},"2030-02-07",{"name":67,"class":68},"University of California, Davis","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100592861","phase-3-studying-chemotherapy-with-or-without-panitumumab-for-unresectable-locally-advanced-or-metastatic-pancreatic-cancer-without-kras-mutations-100592861","NCT06998940","Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations","Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas\n* Participants must have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status determined by tumor tissue-based NGS assay. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)\u002FInternational Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification status\n\n  * NOTE: Blood-based next generation sequencing (NGS) assays, such as circulating tumor deoxyribonucleic acid (DNA) (ctDNA) or liquid biopsies, will not be accepted for meeting eligibility criteria\n* Participants must have documented unresectable and\u002For metastatic disease on CT or magnetic resonance imaging (MRI) imaging completed prior to randomization. Imaging must have been completed within 28 days prior to randomization for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Participants must not have known mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, no amplifications of HER2 and MET, and no gene fusions of RET, NTRK1, and ALK by tumor tissue-based NGS analysis\n\n  * NOTE: Participants who are not tested for these mutations are eligible if they have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status\n* Participants must not have known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery and stable for at least 28 days before randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day).\n\n  * NOTE: Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment\n* Participants must have received only one line of prior systemic cytotoxic chemotherapy for locally advanced or metastatic PDA, and have radiographically progressed, refractory, or intolerant to this therapy.\n\n  * Prior neoadjuvant or adjuvant therapy with 5-FU or gemcitabine-based chemotherapy counts as a line of therapy if the participant's disease progressed to locally advanced or metastatic disease within 6 months of completing treatment\n  * Participants with cancers harboring molecular alterations including microsatellite instability (MSI-high), elevated tumor mutational burden (TMB) (TMB ≥ 10 mut\u002FMb), and FGFR1-3, NRG1, and ROS fusions are allowed to have received an additional line of targeted therapy applicable to the respective molecular alterations at the treating investigators discretion.\n  * Prior maintenance therapy with Olaparib or Rucaparib for germline or somatic BRCA1\u002F2 or PALB2 mutations does not count as a line of therapy.\n* Participants must not have prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab)\n* Participants must not have prior treatment with an EGFR tyrosine kinase inhibitor (e.g., erlotinib)\n* Participants must not have received any pancreatic anticancer therapy (e.g., standard of care or investigational chemotherapy, molecularly targeted therapy, or radiation) within 14 days prior to randomization\n* Participants must not have a known contraindication to receiving chosen chemotherapy backbone at the planned doses in accordance with the local approved label\n* Participant must be ≥ 18 years old at the time of randomization\n* Participants must have Zubrod performance status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Absolute neutrophil count ≥ 1.0 x 10\\^3\u002FuL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n\n  * Note: Use of growth factor support (e.g., Granulocyte Colony-Stimulating Factor \\[G-CSF\\] or romiplostim \\[Nplate\\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed\n* Hemoglobin ≥ 8 g\u002FdL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n\n  * Note: Use of growth factor support (e.g., G-CSF or romiplostim \\[Nplate\\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed\n* Platelets ≥ 75 x 10\\^3\u002FuL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n\n  * Note: Use of growth factor support (e.g., G-CSF or romiplostim \\[Nplate\\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Aspartate aminotransferase (AST) ≤ 10 x upper limits of normal (ULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Participants must have a creatinine ≤ the IULN OR measured OR calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Participants with known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete patient reported outcomes (FACT-G and PRO-CTCAE) questionnaires in English or Spanish must be offered the opportunity to participate in the quality-of-life studies\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":78,"type":20},94,[80],"PHASE3","This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil \\[5-FU\\] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or 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). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.",[83,27,28,29,31],"Locally Advanced Pancreatic Adenocarcinoma","2026-05-19",{"date":86,"type":36},"2026-05-22",{"date":88,"type":36},"2026-05-13",{"date":90,"type":20},"2030-12",{"name":92,"class":93},"SWOG Cancer Research Network","NETWORK",274,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100521733","lotus-cc-an-observational-research-study-to-uncover-subtypes-of-cancer-cachexia-100521733","NCT06073431","LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia","Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia","LOTUS","Inclusion Criteria:\n\n* Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer\n\n  * Note: Patients do not need to have cachexia to be eligible\n* Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.\n\n  * NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended \\> 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy \\[RT\\]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Be able to understand, speak and read English\n* Be 18 years of age or older\n\nExclusion Criteria:\n\n* Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee\n* Have any planned major surgeries within the next 3 months\n* Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer\n* Be pregnant",{"count":104,"type":20},800,"OBSERVATIONAL","This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.",[108,109,110,111,112,29,113,114,31],"Advanced Colorectal Carcinoma","Advanced Lung Non-Small Cell Carcinoma","Advanced Pancreatic Adenocarcinoma","Stage IV Colorectal Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Unresectable Colorectal Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","2026-01-07",{"date":117,"type":36},"2026-01-09",{"date":119,"type":36},"2023-12-04",{"date":121,"type":20},"2028-09-30",{"name":123,"class":68},"University of Rochester",225]