[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreas-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreas-cancer-metastatic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,154,221],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644113","phase-1-samuraciclib-in-combination-with-gemcitabinenab-paclitaxel-in-patients-with-metastatic-basal-like-pancreatic-cancer-100644113",false,"NCT07665684","Samuraciclib in Combination With Gemcitabine\u002FNab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer","Phase Ib\u002FII Study of Samuraciclib in Combination With Gemcitabine\u002FNab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer","SONIC","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of screening.\n2. Written informed consent and any locally required authorization (eg, data privacy) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening.\n4. Must have life expectancy ≥ 12 weeks at the time of screening.\n5. Histologically or cytologically confirmed PDAC: Eligible histological variants include: mucinous adenocarcinoma, independent cell adenocarcinoma, adenosquamous carcinoma, adenocarcinoma not otherwise specified (NOS).\n6. Dose Escalation: All patients with metastatic PDAC will be permitted to enrol.\n7. Dose Expansion: Patients with metastatic basal-like PDAC will be permitted to enrol, based on the PurIST assay or by transcriptomic sequencing. Patients will be permitted to start no more than one cycle of gemcitabine\u002Fnab-paclitaxel while waiting for transcriptional subtype results in the dose expansion cohort.\n8. Radiographic evidence of metastatic disease that is measurable per RECIST 1.1.\n9. Adequate organ and marrow function within 28 days prior to dosing on Day 1.\n10. Adequate liver function (AST ≤2.5 times the institutional upper limit of normal, total bilirubin ≤2 times the institutional upper limit of normal) at the baseline visit. Patients are permitted to enroll with biliary obstruction, as long as they undergo appropriate biliary decompression (can be done at the same time as endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB)) and hepatic parameters have improved at time of baseline visit.\n11. Patients must have either de novo metastatic disease or recurrence \\>6 months after completion of neoadjuvant or adjuvant intent systemic therapy.\n12. Patients must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments at the time of enrollment (excluding neuropathy which can be ≤ Grade 2, and alopecia)\n13. Patients must be able to take oral medications.\n14. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening to 180 days after the final dose of study treatment. It is strongly recommended for the male partner of a female patient to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n15. Nonsterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment. It is strongly recommended for the female partner of a male patient to also use a highly effective method of contraception throughout this period. In addition, male patients must refrain from sperm donation while on study and for 180 days after the final dose of study treatment.\n\nExclusion Criteria:\n\n1. Participants receiving any other study agents concurrently with the study drugs.\n2. Known homologous recombination deficient pancreatic cancer, including germline or somatic BRCA1\u002F2 or PALB2 mutations\n3. Concurrent enrolment in another therapeutic clinical study. Enrolment in observational or supportive care studies will be allowed.\n4. History of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator.\n5. Patients with a history of Grade 3 or greater thromboembolic events in the prior 3 months to the scheduled first dose of study treatment or thromboembolic event of any grade with ongoing symptoms.\n6. Patients with prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment.\n7. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n8. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n9. Other invasive malignancy within 2 years. Non-invasive malignancies (ie, cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition. Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of study treatment and of low potential risk for recurrence are permitted.\n10. Known allergy or hypersensitivity to investigational product formulations.\n11. Active grade 3 or greater edema (eg, peripheral, pulmonary).\n12. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n13. Participants with known untreated brain metastases are excluded. Patients with a history of brain metastases are permitted to enroll if they have been treated and have been stable for a minimum of one month on imaging. Participants must be off all corticosteroids at the time of enrolment.\n14. Major surgery (as defined by the investigator) within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery. Local procedures (eg, placement of a systemic port, core needle biopsy, etc) are allowed, without needing to wait for the 28 day recovery period.\n15. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study.\n16. Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of patient safety or study results.","ALL","18 Years",{"count":20,"type":21},67,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to find the highest dose of a drug, samuraciclib, that can be given with standard of care chemotherapy (gemcitabine and nab-paclitaxel) without causing very severe side effects. This is done by starting at a dose lower than the one that is used when samuraciclib is taken by itself without chemotherapy. The main question it aims to answer is:\n\n• For patients with newly diagnosed metastatic pancreatic cancer, what is the safety and tolerability of samuraciclib with gemcitabine\u002Fnab-paclitaxel?\n\nParticipants will:\n\n* Undergo a tumor biopsy.\n* Be treated with samuraciclib in combination with their standard of care chemotherapy (gemcitabine\u002Fnab-paclitaxel).\n* Donate research blood samples.",[28,29,30,31,32],"Pancreas Ductal Adenocarcinoma","Pancreas Cancer, Metastatic","Pancreatic Adenocarcinoma Metastatic","Adenosquamous Carcinoma of the Pancreas","Mucinous Adenocarcinoma","NOT_YET_RECRUITING","2026-06-18",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":21},"2026-07",{"date":41,"type":21},"2030-05",{"name":43,"class":44},"University Health Network, Toronto","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":138,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":45},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","99 Years",{"count":55,"type":21},360,[57],"NA","Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,29,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Pancreas Cancer","Liver Cancer","Colon Cancer","Biliary Tract Cancer","Stomach Cancer","Rectum Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage III","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Rectal Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[139,140,141,142,143],"Virtual Reality","VR","support","GI cancer","cancer pain","RECRUITING","2026-02-18",{"date":147,"type":37},"2026-02-20",{"date":149,"type":37},"2021-10-05",{"date":151,"type":21},"2027-03-16",{"name":153,"class":44},"Cedars-Sinai Medical Center",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":183,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":220},"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":163,"type":21},24,[24],"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.",[30,167,168,169,170,171,172,173,174,175,176,177,178,179,180,29,82,65,181,182],"BRCA1 Mutation","BRCA2 Mutation","Pancreatic Acinar Cell Carcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer","Metastatic Pancreatic Cancer","Metastatic Pancreatic Ductal Adenocarcinoma","Breast Cancer Metastatic","Breast Cancer Stage IV","Pancreatic Cancer Stage IV","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","Adenocarcinoma of the Breast","PALB2 Gene Mutation","Stage IV Pancreatic Cancer","Stage 4 Pancreatic Cancer",[184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209],"pancreatic adenocarcinoma","pancreatic cancer","BRCA","BRCA1","BRCA2","melphalan","BCNU","carmustine","vitamin C","vitamin B12b","autologous stem cell infusion","stage 4 pancreatic cancer","metastatic pancreatic cancer","pancreatic acinar cell carcinoma","pancreatic ductal adenocarcinoma","PDAC","breast cancer","stage 4 breast cancer","stage IV pancreatic cancer","stage IV breast cancer","stem cells","HER2-negative breast cancer","PALB2","metastatic breast cancer","BRCA pancreatic cancer","BRCA breast cancer","2026-01-27",{"date":212,"type":37},"2026-01-29",{"date":214,"type":37},"2021-01-13",{"date":216,"type":21},"2028-12",{"name":218,"class":219},"General Oncology, Inc.","INDUSTRY",2,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":45},"100619216","phase-1-sl-28-for-advanced-solid-tumours-100619216","NCT07341737","SL-28 for Advanced Solid Tumours","A Phase 1\u002F2, Multicentre, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of SL-28 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\n* Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the study\n* Adult males and females ≥18 years of age at screening\n* Life expectancy of at least 3 months\n* Histologically or cytologically confirmed unresectable advanced solid tumor (recurrent, metastatic, or locally advanced)\n* Disease refractory to, intolerant of, or refusal of standard therapies, including immunotherapy and molecular\u002Fbiomarker-directed treatments, as determined by the Principal Investigator (PI) or delegate\n* Eligible tumor types include:\n* Head and neck squamous cell carcinoma\n* Thoracic malignancies (small-cell lung cancer, non-small cell lung cancer, esophageal cancer)\n* Gastrointestinal malignancies (gastric, liver, colorectal, pancreatic adenocarcinoma)\n* Genitourinary malignancies (bladder, renal cell, prostate cancer)\n* Gynecologic malignancies (ovarian, endometrial cancer)\n* Breast cancer and melanoma\n* Evaluable disease per RECIST v1.1\n* ECOG performance status 0-1 (or up to 2 at PI discretion)\n* Adequate organ function, defined as:\n* Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for liver metastases or Gilbert's syndrome)\n* AST, ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion)\n* Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault) or eGFR ≥50 mL\u002Fmin (CKD-EPI)\n* Absolute neutrophil count ≥1,000\u002Fmm³\n* Platelet count ≥100,000\u002Fmm³\n* Hemoglobin ≥90 g\u002FL without transfusion within 2 weeks\n* Prothrombin time and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation)\n\nFemale patients:\n\n-Non-childbearing potential (surgically sterile or postmenopausal), or of childbearing potential with negative pregnancy tests and agreement to effective contraception through 90 days post-dose\n\nMale patients:\n\n* Agreement not to donate sperm for 90 days post-dose\n* Agreement to use adequate contraception as applicable\n* Suitable venous access for blood sampling\n* Willingness and ability to comply with study procedures and protocol requirements\n\nExclusion Criteria:\n\n* Ongoing toxicities ≥ Grade 2 per NCI CTCAE v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies)\n* NYHA Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG\n* QTcF \\>470 ms (females) or \\>450 ms (males)\n* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n* Requirement for systemic corticosteroids or other immunosuppressive therapy that cannot be discontinued ≥14 days prior to dosing\n* Prior therapies within restricted timeframes:\n* Immune checkpoint inhibitors or biologics within 28 days\n* Antineoplastic therapies, surgery, radiotherapy, or radiopharmaceuticals within 21 days\n* Unapproved investigational drugs within 5 half-lives\n* Nitrosoureas or mitomycin C within 6 weeks\n* Concurrent malignancy within 5 years, except specified low-risk cancers\n* Pregnancy or breastfeeding\n* Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection\n* Inability or unwillingness to comply with protocol procedures\n* History of anaphylaxis or significant allergy interfering with participation\n* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, neurologic, psychiatric, or immunologic disease within 6 months\n* Conditions affecting drug absorption, distribution, metabolism, or excretion\n* Receipt of live vaccines within 28 days prior to screening\n* Participation in another investigational study within 30 days prior to screening",{"count":229,"type":21},60,[24,25],"Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.",[233,234,29,235,236,237,238,239,66,240,241,242,243,244,245,246,247,248],"Head & Neck Cancer","Pancreas Carcinoma","Lung Adenocarcinoma","Lung Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Esophageal Cancer","Stomach (Gastric) Cancer","Intestinal Cancer","Bladder Cancer","Renal Cancer","Prostate Cancer","Melanoma (Skin Cancer)","Breast Cancer","Ovarian Cancer","Endometrial Cancer","Colorectal Cancer","2026-01-13",{"date":251,"type":37},"2026-01-15",{"date":253,"type":21},"2026-02-01",{"date":255,"type":21},"2027-03-01",{"name":257,"class":219},"Second Life Therapeutics"]