[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-neoplasms":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,106,0,25,[9,53,84,116,149,174,212,272,304,334,391,417,440,463,483,521,546,574,605,626,653,690,738,762,782],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100648006","hepatic-artery-infusion-of-carfilzomib-in-participants-with-liver-metastatic-disease-previously-treated-with-hepatic-artery-infusion-pump-therapy-100648006",false,"NCT07715903","Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy","Phase I Study Evaluating Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy","* INCLUSION CRITERIA:\n* Participants must have a histologically or cytologically confirmed by pathology report diagnosis of colorectal cancer (CRC), intrahepatic cholangiocarcinoma (ICC), or adrenocortical carcinoma (ACC).\n* Participants must have measurable liver-dominant metastatic disease. Note: liver-dominant metastatic disease is defined as \\>=75% of metastatic disease present in the liver as assessed by the principal investigator.\n* Extrahepatic disease should be treated with anticancer therapy, if applicable, and should be stable by RECIST criteria for at least 6 weeks prior to study treatment initiation.\n* Participants must have previously undergone hepatic artery infusion pump therapy and have a functioning hepatic artery infusion pump in place.\n* Participants must have progressed on, been intolerant of, or have residual disease after HAI floxuridine and appropriate current standard-of-care treatment.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 2.\n* Participants must have an adequate organ and marrow function as defined below:\n\nLeukocytes \\> 3,000\u002FmcL\n\nHemoglobin \\>= 9 mg\u002FdL\n\nAbsolute neutrophil count \\> 1,500\u002FmcL\n\nPlatelets \\> 100,000\u002FmcL\n\nTotal bilirubin \\\u003C 2 X institutional upper limit of normal (ULN)\n\nAspartate aminotransferase (AST) \\\u003C 2.5 X institutional (ULN)\n\nAlanine aminotransferase (ALT) \\\u003C 2.5 X institutional (ULN)\n\nCreatinine \\\u003C2 X institutional (ULN)\n\n* Participants positive for human immunodeficiency virus (HIV) 1\u002F2 antibody must have a negative HIV viral load.\n* Participants positive for Hepatitis C (HCV) antibody must have a negative HCV viral load.\n* Participants positive for Hepatitis B (HBV) core antibody (HBcAb) must have a negative HBV viral load. Note: Participants positive for Hepatitis B surface antigen (HBsAg) are excluded.\n* Women of childbearing potential (WOCBP) must agree to use effective contraception (barrier, hormonal, intrauterine device, abstinence, surgical sterilization) at the study entry and up to 6 months after the last dose of the study drug. A participant may request a male partner to use an effective form of contraception to fulfill this requirement (e.g., condom\u002Fbarrier).\n\nMen must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 3 months after the last dose of the study drug. A participant may request a female partner to use an effective form of contraception to fulfill this requirement (e.g., intrauterine device, hormonal contraceptives). Men must not freeze or donate sperm within the same period.\n\n* Women who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding from study treatment initiation through 2 weeks after the last dose of the study drug.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with liver metastases amenable to resection.\n* Participants who received floxuridine within 6 weeks prior to the study treatment initiation.\n* Participants who received any anticancer therapy within 2 weeks prior to the study treatment initiation.\n* Participants who received any investigational agents within 4 weeks prior to the study treatment initiation.\n* Participants with incontrovertible radiographic evidence of disease progression per the RECIST definition outside of the liver within 3 months prior to the study treatment initiation. Note: Pulmonary lesions less than 1 cm are allowed.\n* Prior radiation to the liver (Yttrium-90 \\[Y-90\\] or External Beam Radiation Therapy \\[EBRT\\]).\n* History of allergic reactions attributed to compounds of similar chemical composition to CFZ.\n* Positive serum or urine Beta-human chorionic gonadotropin (Beta-HCG) pregnancy test performed at screening.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, evaluated by medical history, electrocardiogram (EKG), physical exam, and laboratory testing, or social situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nCancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump. The HAI pump is installed in the artery that goes to the liver; drugs are administered directly to the liver through this pump. But these tumors often return after treatment. Carfilzomib (CFZ) is a drug approved to treat another kind of cancer. Researchers want to find out if this drug may be helpful when administered through the HAI pump directly to the liver for people with colon, adrenal glands, or bile duct cancer that has spread to the liver.\n\nObjective:\n\nTo test the safety of carfilzomib (CFZ) delivered via a hepatic artery infusion (HAI) pump directly to the liver in people with cancer in their liver.\n\nEligibility:\n\nPeople aged 18 years or older with cancers of the colon, adrenal glands, or bile ducts that spread to the liver and persist after treatment. They must have a functioning hepatic artery infusion (HAI) pump in place from previous treatment of HAI pump therapy.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam, blood tests, imaging scans, and a test of their heart function. They will also have a test to show how the blood flows through their liver: A radioactive substance will be injected into a vein, and a special camera will take pictures of the blood flow for up to 1 hour.\n\nParticipants will receive the study drug for about 6 months. They will visit the clinic once a week. Their HAI pump will be filled with the drug at each visit; the drug will slowly drain from the pump into the liver. Blood tests and imaging scans will be repeated during the study.\n\nParticipants will have follow-up visits 1 and 3 months after their last dose of study drug.\n\nAn optional liver biopsy (tissue sample) for research purposes may be done before the study drug is given, and again (optional) within 28 days after first receiving the study drug. Individuals may participate in the study even if they do not agree to have the biopsies done.\n\n...",[28,29,30,31,32],"Colorectal Neoplasms","Neoplasms","Intrahepatic Cholangiocarcinoma","Adrenocortical Carcinoma","Metastasis, Neoplasm",[34,35,36,37,38,39],"Hepatic artery infusion","Carfilzomib","Colorectal Cancer","Intrahepatic cholangiocarcinoma","Adrenocortical Cancer","Measurable liver metastasis","NOT_YET_RECRUITING","2026-08-20",{"date":43,"type":44},"2026-08-21","ACTUAL",{"date":46,"type":22},"2026-08-26",{"date":48,"type":22},"2031-12-31",{"name":50,"class":51},"National Cancer Institute (NCI)","NIH",1,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":72,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100601754","phase-1-a-study-of-ly4257496-in-participants-with-cancer-omniray-100601754","NCT07114601","A Study of LY4257496 in Participants With Cancer (OMNIRAY)","A Phase 1a\u002Fb Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)","OMNIRAY","Inclusion Criteria:\n\n* Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.\n* Must be assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) to confirm at least 1 of the following:\n\n  * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n  * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases\n* Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.\n* Must have the following histologically or cytologically confirmed diagnosis:\n\n  * Estrogen receptor (ER+)\u002Fhuman epidermal growth factor receptor 2 (HER2-) breast cancer\n  * ER+\u002FHER2+ breast cancer\n  * Esophageal squamous cell carcinoma\n  * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus\n  * Colorectal carcinoma\n  * Metastatic castration-resistant prostate cancer\n  * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible.\n  * Low-grade papillary serous ovarian cancer\n  * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only)\n* For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.\n\n  * To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n  * HER2 status should be determined by local testing, as defined in the relevant ASCO\u002FCAP Guidelines.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.\n* Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.\n\nExclusion Criteria:\n\n* Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted.\n* Has a history of ongoing acute pancreatitis within 1 year of screening.\n* Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.\n* A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.\n* Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.\n* Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:\n\n  * Have positive HBsAg\n  * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1\n  * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy.\n  * Have undetectable HBV DNA ≤14 days of C1D1.\n* Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they:\n\n  * Completed curative antiviral therapy.\n  * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and.\n  * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization.\n* Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection\u002Fdisease and they:\n\n  * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1\n  * Have a viral load of \\\u003C400 copies\u002FmL ≤14 days of C1D1.\n  * Have a CD4+ T-cell count ≥350 cells\u002FmL ≤14 days of C1D1.\n  * Have not had an opportunistic infection within the past 12 months.\n* Has an active second malignancy unless in remission with life expectancy greater than 2 years.\n* Has known hypersensitivity to any component or excipient of LY4257496.",{"count":62,"type":22},421,[25],"The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.",[66,28,67,68,69,70,71],"Breast Neoplasms","Prostate Neoplasm","Endometrial Neoplasms","Neoplasm Metastasis","Stomach Neoplasms","Esophageal Neoplasms",[73],"GRPR-positive","RECRUITING",{"date":43,"type":44},{"date":77,"type":44},"2025-08-06",{"date":79,"type":22},"2035-04",{"name":81,"class":82},"Eli Lilly and Company","INDUSTRY",32,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":52},"100450669","phase-4-tes-rct-fleet-enema-vs-oral-mechanical-bowel-prep-100450669","NCT05148494","TES RCT Fleet Enema vs Oral Mechanical Bowel Prep","Transanal Endoscopic Surgery: a Randomized Controlled Trial Comparing Fleet Enema vs Oral Mechanical Bowel Prep (TESEO Trial)","TESEO","Inclusion Criteria:\n\n* undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons\n\nExclusion Criteria:\n\n* chronic constipation not well controlled with diet or stool softening agents\n* previous pelvic radiation\n* inflammatory bowel disease\n* repeat transanal surgery for the same lesion\n* patient unable to self-administer enemas\n* patient unable to tolerate either of the 2 bowel preps due to medical reasons\n* age over 75\n* clear diagnosis of congestive heart failure\n* daily use of Lasix or similar loop diuretic\n* chronic steroid use\n* Transanal Endoscopic Surgery combined with another surgical procedure","75 Years",{"count":94,"type":22},66,[96],"PHASE4","There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy, to facilitate safe, precise and efficient resection of the rectal lesion and potentially adequate closure of the defect. Both Fleet enemas and oral mechanical bowel preparation are considered standard of care in preparation for TES. This single center two arm single blinded randomized controlled trial will compare the effectiveness of Fleet enemas in comparison to Pico Salax oral mechanical bowel preparation in cleansing the rectum as measured by a modified version of the Ottawa Bowel Prep Scale.",[28,99],"Surgery",[101,102,103,104,105,106,107],"transanal endoscopic surgery","TEM","TAMIS","rectal neoplasm","oral mechanical bowel preparation","fleet enema","Ottawa bowel prep score",{"date":43,"type":44},{"date":110,"type":44},"2022-03-16",{"date":112,"type":22},"2027-10-01",{"name":114,"class":115},"Nova Scotia Health Authority","OTHER",{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":123,"maxAge":19,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100379579","phase-1-metarrestin-ml-246-in-subjects-with-metastatic-solid-tumors-100379579","NCT04222413","Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\\u003C 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell\u002Fsclerosing and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor\n  * has site measurable per RECIST 1.1 (Phase IB only).\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  * Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\\u003C16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)\u002FL,\n  * transfusion-independent platelet count \\>= 100 x 10(9)\u002FL,\n  * Hgb \\>= 9 g\u002F dL (patients who have received \\\u003C= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\\u003C1.5 (or \\\u003C 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT\u002FPE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  --a total bilirubin level \\\u003C= 1.5 x ULN, (total bilirubin \\\u003C= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\\u003C= 3xULN\n  * an ALT level \\\u003C= 3 xULN\n* Adequate renal function defined by:\n\n  --Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\\*\n\n  ---\\\u003C 1.5x institution upper limit of normal OR\n\n  ---\\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n\n  \\*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight: \\>= 35 kg (\\>= 18 years old) or \\>=40 kg (\\>= 12 and \\\u003C 18 years old).\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting\u002Finducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease.\n\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\\u003C= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\\u003C18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and\u002For pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Subjects with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\\\u003C3 months of treatment initiation), infectious causes).\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","12 Years",{"count":125,"type":22},116,[25],"Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.",[129,130,131,132,133,28],"Advanced Solid Tumors","Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Advanced Breast Cancer","Malignant Peripheral Nerve Sheath Tumor",[135,136,137,138,139],"First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose","2026-08-15",{"date":142,"type":44},"2026-08-18",{"date":144,"type":44},"2020-10-27",{"date":146,"type":22},"2028-12-31",{"name":50,"class":51},2,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":156,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":160,"conditions":161,"keywords":166,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":4,"leadSponsor":173,"locationsCount":52},"100202701","obtaining-solid-tumor-tissue-from-people-having-biopsy-or-surgery-for-certain-types-of-cancer-100202701","NCT01915225","Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer","Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors","* INCLUSION CRITERIA:\n* Participants must be 2 years of age or older. Note: Participants greater than or equal to 2 and \\\u003C 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the biospecimen sampling (e.g., blood, urine, ascites, bile, or \\[clinically indicated\\] resected tumor tissue) does not add risk to the clinically indicated procedures.\n* Participants who have premalignant, primary, or metastatic solid tumors based upon either radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or histological\u002Fcytological analysis that requires surgery or biopsy as part of the diagnosis, prevention, treatment, and\u002For follow-up.\n* Participants without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.\n* Participants should have laboratory and physical examination parameters within acceptable limits prior to biopsy or surgery.\n* Participants must be planning to undergo surgery or biopsy as part of their normal treatment plan.\n* Ability of participant, parent\u002Fguardian or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone.","2 Years",{"count":158,"type":22},1800,"OBSERVATIONAL","Background:\n\n\\- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).\n\nObjectives:\n\n\\- To collect tissue samples for use in studying new ways to treat tumors.\n\nEligibility:\n\n* Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC.\n* Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care.\n\nDesign:\n\n* Before their procedure, participants will have a small blood sample taken.\n* Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours.\n* For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis.\n* Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.",[28,162,163,164,165],"Gastric Neoplasms","Cholangiocarcinoma","Bile Duct Cancer","Pancreas Cancer",[167,99,168,169],"Tissue Procurement","Metastasectomy","Natural History",{"date":142,"type":44},{"date":172,"type":44},"2013-07-21",{"name":50,"class":51},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":185,"conditions":186,"keywords":196,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100610070","phase-3-symbiotic-gi-03-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-metastatic-colorectal-cancer-100610070","NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":182,"type":22},800,[184],"PHASE3","The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[187,188,189,190,191,192,193,194,195,28],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases",[197,198,199,200,201],"mCRC","metastatic disease","first-line","metastatic colorectal cancer","colon cancer","2026-08-14",{"date":204,"type":44},"2026-08-17",{"date":206,"type":44},"2025-12-11",{"date":208,"type":22},"2031-08-01",{"name":210,"class":82},"Pfizer",308,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":220,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":225,"conditions":226,"keywords":245,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","1 Year",{"count":222,"type":22},30,[224,184],"PHASE2","This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[227,228,229,230,190,231,232,233,234,235,236,237,28,238,239,240,241,242,243,244],"Haematological Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Cancer","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Glioma","Multiple Myeloma","Thyroid Carcinoma, Anaplastic","Solid Tumour","Pancreatic Diseases",[246,247,234,248,249,250,251,252,253,254,190,255,256,257,258,259,260,261,262],"Adult","Antineoplastic Agents","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult","2026-08-13",{"date":204,"type":44},{"date":266,"type":44},"2026-04-01",{"date":268,"type":22},"2029-10",{"name":270,"class":115},"Cancer Research UK",27,{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":279,"sex":280,"minAge":281,"maxAge":92,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100650503","increasing-breast-and-colorectal-cancer-screening-in-the-community-100650503","NCT07748377","Increasing Breast and Colorectal Cancer Screening in the Community","A Pilot Trial of a Community-Based Strategy to Improve Colorectal and Breast Cancer Screening","Inclusion Criteria:\n\n* Age 45-75 years old\n* Self-identify as Chinese and born outside of the U.S.\n* Speaks Mandarin, Cantonese, or English\n* Not up to date on BC screening (i.e., have not had a mammogram within the past two years)\n* Not up to date on CRC screening (i.e., have not had any of the following tests)\n\n  * Colonoscopy within the past 10 years\n  * Fecal immunochemical tests\u002Ffecal occult blood tests within the past year or multi-target stool DNA test within the past three years\n  * Flexible sigmoidoscopy within the past 5 years\n  * CT colonography within the past 5 years\n\nExclusion Criteria:\n\n* Life expectancy ≤ 10 years or other pre-existing conditions whereby CRC or BC screening would not be recommended\n* Personal history of BC or CRC\n* Prior history of a total colectomy or mastectomy\n* Lacks capacity to provide informed consent",true,"FEMALE","45 Years",{"count":283,"type":22},80,[285],"NA","The goal of the proposed study is to conduct a pilot randomized controlled trial (RCT) of Chi gung, a community-based intervention using peer education and tailored navigation to simultaneously improve colorectal (CRC) and breast cancer (BC) screening rates.",[28,66],[289,290,291,292,293,294],"Community Engaged Research","Early Detection of Cancer","Colorectal Cancer Screening","Breast Cancer Screening","Patient Navigation","Community Health Workers","2026-08-12",{"date":202,"type":44},{"date":298,"type":22},"2026-09",{"date":300,"type":22},"2029-03",{"name":302,"class":115},"Icahn School of Medicine at Mount Sinai",7,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":312,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":322,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100486305","colonoscopy-vs-stool-testing-for-older-adults-with-colon-polyps-100486305","NCT05612347","Colonoscopy vs Stool Testing for Older Adults With Colon Polyps","Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps","COOP","Inclusion Criteria:\n\n* English or Spanish speaking\n* Personal history of colorectal polyps\n* Most recent colonoscopy with ≤2 non-advanced polyps\n* Currently due or coming due within 12 months for colonoscopy\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Personal history of colorectal cancer\n* Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome)\n* Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)\n* Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps\n* Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year)\n* Patients unable to provide written informed consent","65 Years","82 Years",{"count":315,"type":22},8946,[285],"This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.",[319,28,320,36,321],"Colorectal Polyp","Colorectal Adenoma","Digestive System Disease",[323,324],"Colonoscopy","Fecal immunochemical test (FIT)","2026-08-11",{"date":263,"type":44},{"date":328,"type":44},"2023-06-14",{"date":330,"type":22},"2035-12-31",{"name":332,"class":115},"Dartmouth-Hitchcock Medical Center",24,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":349,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":148},"100639442","a-first-in-human-trial-of-blu-924-sar449336-in-advanced-solid-tumors-harboring-kras-mutations-100639442","NCT07629960","A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations","A Phase 1\u002F2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of metastatic Kirsten rat sarcoma viral oncogene homolog (KRAS)-mutant pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) with evidence of a single KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA).\n2. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n4. Patients must have received all standard therapies for their cancer type in the metastatic setting, unless they are unable to receive such therapies due to clinical characteristics, comorbidities, or other medically justified reasons.\n\nExclusion Criteria:\n\n1. History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.\n2. Active brain metastases (participants with asymptomatic brain metastases may be eligible).\n3. Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.\n4. Active or uncontrolled systemic infection, such as tuberculosis, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":342,"type":22},265,[25,224],"A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 \u002F SAR449336, a pan-KRAS inhibitor, in participants with advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer harboring KRAS mutations.",[346,347,28,348],"Advanced Solid Tumor","Non-Small Cell Lung Cancer","Pancreatic Ductal Adenocarcinoma",[350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381],"Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","Metastatic Pancreatic Ductal Adenocarcinoma","KRAS G12A","KRAS G12C","KRAS G12D","KRAS G12S","KRAS G12V","Solid Tumor, Adult","KRAS-mutant","KRAS-positive","KRAS G13D","Pan-KRAS inhibitor","KRAS inhibitor","First-in-human","Solid tumor","Advanced cancer","Adult solid tumor","Metastatic solid tumor","Colorectal cancer","Colon cancer","Rectal cancer","Metastatic colorectal cancer","Pancreatic cancer","Pancreatic ductal adenocarcinoma","PDAC","Metastatic pancreatic cancer","Lung cancer","NSCLC","Precision oncology","Targeted therapy","2026-08-06",{"date":384,"type":44},"2026-08-10",{"date":386,"type":44},"2026-06-04",{"date":388,"type":22},"2031-07",{"name":390,"class":82},"Blueprint Medicines Corporation",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":222},"100609377","phase-1-a-study-of-ly4337713-in-participants-with-fap-positive-solid-tumors-100609377","NCT07213791","A Study of LY4337713 in Participants With FAP-Positive Solid Tumors","A Dose Escalation and Dose Optimization Phase 1a\u002F1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)","FiREBOLT","Inclusion Criteria:\n\n* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment\n* Must have histologically or cytologically confirmed diagnosis of one of the following:\n\n  * Adenocarcinoma of the pancreas\n  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer\n  * HER2-positive breast cancer\n  * Triple negative breast cancer (TNBC)\n  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)\n  * Other solid tumors\n\n    * Gastric cancer (adenocarcinoma)\n    * Colorectal cancer (CRC)\n    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)\n    * Cholangiocarcinoma\n* Must have received prior treatments as indicated below:\n\n  * Phase 1a\n\n    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.\n    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4\u002F6 inhibitor.\n    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).\n    * TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.\n    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.\n    * Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.\n  * Phase 1b:\n\n    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.\n* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Measured creatinine clearance ≥60 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.\n* Have significant cardiovascular disease\n* Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT\u002F(RR0.33)\n* Have evidence of ongoing and untreated urinary tract obstruction\n* Had previous hemi- or total-body radiation.\n* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)\n* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).",{"count":400,"type":22},241,[25],"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.",[237,66,404,28,71,70,163],"Pancreatic Intraductal Neoplasms",[406,407,408,409],"Cancer-associated fibroblasts (CAF)","Lutetium-177","LuFAP","Lu-177-FAP","2026-08-05",{"date":382,"type":44},{"date":413,"type":44},"2025-10-22",{"date":415,"type":22},"2033-03",{"name":81,"class":82},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":303},"100573826","phase-1-a-study-of-dm002-in-patients-with-advanced-solid-tumors-100573826","NCT06751329","A Study of DM002 in Patients With Advanced Solid Tumors","A Phase I\u002FIIa, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nCommon Inclusion Criteria (Part 1 and Part 2)\n\n1. Subjects must have the ability to understand and willingness to sign a written informed consent document.\n2. Subjects must be ≥18 years of age at the time of signing the informed consent form.\n3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n4. Has a life expectancy of ≥3 months.\n5. Participants must meet the following laboratory values within 7 days prior to first dose of study drug:\n\n   Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to laboratory assessments at Screening.\n   * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n   * Platelet count ≥100 × 10⁹\u002FL;\n   * Hemoglobin ≥9 g\u002FdL;\n   * Calculated creatinine clearance (CrCL) \\>60 mL\u002Fmin (Cockroft-Gault Equation);\n   * Total bilirubin ≤ 1.5 x ULN;\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN;\n   * International normalized ratio (INR)\\\u003C2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant therapy who must have prothrombin time\u002FINR within therapeutic range as deemed appropriate by the Investigator.\n6. Has measurable disease based on RECIST version 1.1.\n7. Participants are required to provide tumor tissue specimens obtained within the previous 3 years for the measurement of MUC1 and\u002For HER3 and other biomarkers. For those subjects who are unable to provide tissue samples will be encouraged (but not mandatory) to undergo biopsy if the risk is manageable. If the biopsy is not possible, it should inform the sponsor for enrolment.\n\nExclusion Criteria:\n\n1. Subjects have another active invasive malignancy within 5 years, with the following exceptions and notes:\n\n   1. History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission 5 years after treatment with curative intent is allowed.\n   2. Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).\n2. Current or history of a hematologic malignancy.\n3. Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.\n4. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\\>20 mg prednisone or equivalent) for at least 4 weeks.\n5. History of known allergies to ADC, or prior discontinuation of an ADC due to treatment-related toxicities. Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload, and treatment history with any investigational drug within 4 weeks before enrolment in the study.\n6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.\n7. Has a pre-existing clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or pre-existing ocular disorders.\n8. Clinically uncontrolled intercurrent illness, including but not limited to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.\n9. Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) \\>470 msec obtained from triplicate 12-lead ECGs at baseline; using concomitant medications that would prolong the QT interval.\n10. Left ventricular ejection fraction \\\u003C50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug.\n11. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies\u002Fml or 500 IU\u002Fml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.\n12. Known human immunodeficiency virus (HIV) infection which is not well controlled. Participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)\u002Fethics committee. All the following criteria are required to define an HIV infection (positive HIV1\u002F2 antibodies test) that is well controlled: HIV viral load \\\u003C400 copies\u002FmL, CD4+ T- cell counts ≥350 cells\u002FμL, no history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.\n13. Subjects who are from endemic areas (refer to WHO high tuberculosis burden country list, China is endemic area) will be specifically screened for tuberculosis with any available test. Subjects with active tuberculosis are excluded. Subjects who have received bacille Calmette-Guerin vaccination may have a false positive result of purified-protein derivative (PPD) test. These subjects are eligible if they have a negative result of interferon gamma release assay (IGRA).\n14. Has received a live vaccine within 30 days prior to the first dose of study drug.\n15. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrolment\u002Frandomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.\n16. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.\n17. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.\n18. Participants who took drugs or food which can strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4\u002F5 within 2 weeks prior to the first dose of DM002 or within 5 half-lives, whichever is longer.",{"count":425,"type":22},280,[25,224],"The goal of study：\n\nThe study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.\n\nIn Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.\n\nThe purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.\n\nIn Part 2, participants will receive the best dose level that was determined in Part 1 of the study.\n\nThe purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.\n\nParticipants will:\n\nParticipants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.",[237,429,68,28,430,431],"Prostatic Neoplasms","Solid Carcinoma","Pancreatic Cancer",{"date":433,"type":44},"2026-08-07",{"date":435,"type":44},"2025-02-17",{"date":437,"type":22},"2028-04-18",{"name":439,"class":82},"Xadcera Biopharmaceutical (Suzhou) Co., Ltd.",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":462},"100573731","phase-3-a-study-of-amivantamab-and-folfiri-versus-cetuximabbevacizumab-and-folfiri-in-participants-with-krasnras-and-braf-wild-type-colorectal-cancer-who-have-previously-received-chemotherapy-100573731","NCT06750094","A Study of Amivantamab and FOLFIRI Versus Cetuximab\u002FBevacizumab and FOLFIRI in Participants With KRAS\u002FNRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy","A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab\u002FBevacizumab + FOLFIRI in Participants With KRAS\u002FNRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy","OrigAMI-3","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease\n* Determined to have kirsten rat sarcoma viral oncogene\u002Fneuroblastoma RAS viral oncogene homolog (KRAS\u002FNRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and\u002For central next-generation sequencing (NGS) testing\n* Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible\n* Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1\n* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1\n* Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy\n\nExclusion Criteria:\n\n* Has medical history of (noninfectious) interstitial lung disease (ILD) \u002Fpneumonitis\u002Fpulmonary fibrosis or has current ILD\u002Fpneumonitis\u002Fpulmonary fibrosis, or where suspected ILD\u002Fpneumonitis\u002Fpulmonary fibrosis cannot be ruled out by imaging at screening\n* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI\n* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Participant with known mismatch repair deficiency (dMMR)\u002F high microsatellite instability (MSI-H) status who has not received immunotherapy treatments\n* Participant with known human epidermal growth factor receptor 2 (HER2)- positive\u002Famplified tumor\n* Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)",{"count":449,"type":22},700,[184],"The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene\u002F neuroblastoma RAS viral oncogene homolog (KRAS\u002F NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.",[28],"2026-07-30",{"date":455,"type":44},"2026-07-31",{"date":457,"type":44},"2024-12-12",{"date":459,"type":22},"2029-04-13",{"name":461,"class":82},"Janssen Research & Development, LLC",250,{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"100567023","phase-3-a-study-of-amivantamab-and-mfolfox6-or-folfiri-versus-cetuximab-and-mfolfox6-or-folfiri-as-first-line-treatment-in-participants-with-krasnras-and-braf-wild-type-unresectable-or-metastatic-left-sided-colorectal-cancer-100567023","NCT06662786","A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS\u002FNRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer","A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS\u002FNRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer","OrigAMI-2","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease\n* Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and\u002For central testing (if available)\n* Must agree to the submission of fresh tumor tissue\n* Have measurable disease according to RECIST v1.1\n* Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant\u002Fneoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (\\>) 12 months prior to CRC recurrence\u002Fmetastases\n* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1\n\nExclusion Criteria:\n\n* Has medical history of (noninfectious) interstitial lung disease (ILD) \u002Fpneumonitis\u002Fpulmonary fibrosis or has current ILD\u002Fpneumonitis\u002Fpulmonary fibrosis, or where suspected ILD\u002Fpneumonitis\u002Fpulmonary fibrosis cannot be ruled out by imaging at screening\n* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI\n* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Participant with known mismatch repair deficiency (dMMR)\u002F high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive\u002Famplified tumor\n* Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)",{"count":472,"type":22},1000,[184],"The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)\u002F Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.",[28],{"date":455,"type":44},{"date":478,"type":44},"2024-10-18",{"date":480,"type":22},"2032-01-20",{"name":461,"class":82},238,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":279,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":493,"conditions":494,"keywords":501,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":52},"100649958","methylation-profile-test-methylscape-in-body-fluids-for-multi-cancer-detection-and-monitoring-in-colombia-100649958","NCT07741435","Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia","Evaluation of a Rapid Test for the Detection of Methylation Profiles (Methylscape) in Various Body Fluids as a Universal Biomarker for Cancer Detection and Monitoring","METHYLSCAPE-CO","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Willing and able to participate and to provide the required samples (blood, urine, saliva) and demographic information (age, sex, race\u002Fethnicity, BMI).\n* Able to provide written informed consent for participation and for use of biological samples. For CTIC Biobank samples, prior research-use consent is verified.\n* Demographic\u002Fanthropometric comparability (race, ethnicity, BMI) with other participants; race\u002Fethnicity by self-identification (WHO and national census categories); BMI per WHO categories.\n\nInclusion - Cancer cohort:\n\n* Cancer diagnosis confirmed within 90 days prior to sample collection.\n* Biopsy-proven malignancy with radiological staging.\n* No anticancer treatment at the time of collection or within the previous 3 years.\n* Inclusion - Cancer-free (healthy) cohort:\n* No cancer diagnosis or treatment in the previous 3 years (ICD-O-3 behavior code 2 or 3).\n* Not under evaluation for suspected cancer (verified by medical record review or additional medical evaluation).\n* Subjects with benign tumors (code 0) or tumors of uncertain behavior (code 1) may be included if there is no clinical evidence of progression or malignancy.\n\nAdditional criteria - tumor-burden monitoring (Sub-study 2b):\n\n* Biopsy-confirmed cancer.\n* ECOG performance status ≤ 2.\n\nExclusion Criteria (both cohorts):\n\n* Failure to meet the general or cohort-specific inclusion criteria.\n* Pregnancy.\n* Organ transplant recipients.\n* Use of demethylating agents (azacitidine, decitabine) or cytotoxic agents (including for autoimmune\u002Finflammatory conditions).\n* Prior or ongoing anticancer therapy: cancer surgery beyond that needed for diagnosis; local, regional, or systemic chemotherapy (including chemoembolization); targeted therapy; immunotherapy (including cancer vaccines); hormonal therapy; or radiotherapy.",{"count":492,"type":22},3250,"DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles.\n\nThis prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging.\n\nThe study also estimates positive and negative predictive values (PPV\u002FNPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.",[29,495,66,496,70,497,28,498,499,290,500],"Solid Tumor","Lung Neoplasms","Uterine Cervical Neoplasms","Urologic Neoplasms","Head and Neck Neoplasms","Neoplasm Recurrence, Local",[502,503,504,505,506,507,508,509,510,511],"DNA methylation","Liquid biopsy","Cell-free DNA (cfDNA)","Multi-cancer early detection (MCED)","Methylscape","Cancer signal origin","Minimal residual disease","Methylation biomarker","Cancer screening","Colombia","2026-07-28",{"date":514,"type":44},"2026-08-03",{"date":516,"type":44},"2025-06-05",{"date":518,"type":22},"2028-01-15",{"name":520,"class":115},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":530,"studyType":159,"phases":4,"briefSummary":531,"conditions":532,"keywords":533,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":52},"100649822","ai-based-stool-image-analysis-for-colorectal-neoplasia-risk-assessment-100649822","NCT07740122","AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment","FECAL-AI: Prospective Observational Validation of AI-Based Stool Image Analysis Against Quantitative Fecal Immunochemical Testing for Colorectal Neoplasia Risk Assessment","FECAL-AI","Inclusion Criteria:\n\n* Age 18 years or older.\n* Referred for screening or diagnostic colonoscopy at Hospital Dr. Sótero del Río.\n* Quantitative fecal immunochemical testing planned or completed within 30 days before or after stool image submission.\n* Able to submit at least one stool image using the FAEX Health mobile application, independently or with assistance.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide written informed consent.\n* Previous enrollment in the study.\n* Unable to complete stool-image capture, even with assistance.\n* Study images and clinical data cannot be reliably linked using the assigned study code.",{"count":462,"type":22},"1 Day","This prospective observational substudy evaluates the association between artificial intelligence-derived features from stool images analyzed using the FAEX Health digital platform and fecal immunochemical test results in adults undergoing colorectal cancer screening or diagnostic evaluation. Participants will capture stool images using a mobile application. The primary analysis will compare AI-derived image outputs with quantitative FIT values and FIT positivity. Secondary exploratory analyses will assess associations with colonoscopy and histopathological findings when these results are available. The platform will be used exclusively for research and will not provide diagnoses, replace clinical evaluation, or influence medical decisions.",[28],[291,534,535,536,323,537],"Artificial Intelligence","Stool Image Analysis","Fecal Immunochemical Test","Digital Health",{"date":455,"type":44},{"date":540,"type":44},"2026-05-08",{"date":542,"type":22},"2026-12",{"name":544,"class":545},"Servicio de Salud Metropolitano Sur Oriente","OTHER_GOV",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":279,"sex":17,"minAge":281,"maxAge":554,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":557,"briefSummary":558,"conditions":559,"keywords":561,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":52},"100598435","preventing-early-onset-colorectal-cancer-in-the-va-100598435","NCT07071454","Preventing Early-Onset Colorectal Cancer in the VA","Preventing Early-Onset Colorectal Cancer in the VA Using a Multilevel Screening Intervention","PRECISE","Inclusion Criteria:\n\n* Age 45-49 years at screening\n\nExclusion Criteria:\n\n* Up-to-date with CRC screening based on the USPSTF guideline (e.g., colonoscopy within the past 10 years or FIT within the past year)\n* Prior CRC diagnosis\n* Prior total colectomy\n* Limited life expectancy (defined as terminal illness, hospice enrollment, or documented life expectancy \\\u003C6 months on the medical problem list or a health factor in the EHR\n* Deactivated national CRC screening and surveillance reminder (due to risk level or comorbidities)","49 Years",{"count":556,"type":22},536,[285],"Colorectal cancer is a leading cause of cancer death among Veterans. The starting age for colorectal cancer screening has been lowered from 50 to 45 years in response to the rising incidence of early-onset colorectal cancer (EOCRC), but how to best engage younger Veterans in screening is unclear. The investigators will 1) develop and validate a novel risk score for EOCRC derived from the VA electronic health record data, 2) conduct a multilevel screening intervention that targets individuals aged 45-49 years and informs high-risk individuals and their providers about their risk status for EOCRC, and 3) determine barriers and facilitators to implementing the intervention using a qualitative process evaluation. Aim 2 is the focus of the trial. The overall goal of this study is to create and test a risk stratification approach to prevent EOCRC, which may be especially useful for younger individuals who are less likely to participate in preventive care.",[28,560],"Mass Screening",[562,563,564],"early onset colorectal cancer","risk stratification","behavioral intervention",{"date":566,"type":44},"2026-07-29",{"date":568,"type":22},"2026-10-01",{"date":570,"type":22},"2029-06-30",{"name":572,"class":573},"VA Office of Research and Development","FED",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":584,"conditions":585,"keywords":589,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":604},"100526215","phase-1-a-study-of-sgn-ceacam5c-in-adults-with-advanced-solid-tumors-100526215","NCT06131840","A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors","An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Tumor type:\n\n   * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.\n\n     * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).\n     * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.\n   * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.\n\n     * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.\n     * PDAC with one or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.\n     * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.\n     * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1\u002FPD-L1 inhibitor. In addition, participants with tumor genomic mutations\u002Falterations for which approved targeted therapies are available per local standard of care, must have received such therapies.\n     * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1\u002FPD-L1 inhibitor.\n   * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.\n   * CRC participants in Part D and Part E (5FU\u002FLV + bevacizumab and 5FU\u002FLV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU\u002FLV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.\n\n   \\> 2L PDAC participants in Part E (5FU\u002FLV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n\n   \\> 1L PDAC participants in Part E (5FU\u002FLV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant\u002Fneoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant\u002Fneoadjuvant chemotherapy are eligible.\n2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and\u002For submission of archival tissue:\n\n   * Monotherapy dose optimization (Part B)\n   * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts\n3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.\n\nExclusion Criteria:\n\n1. Previous exposure to CEACAM5-targeted therapy.\n2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).\n3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Active cerebral\u002Fmeningeal disease related to the underlying malignancy. Participants with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral\u002Fmeningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).\n\n   \\> Criteria related to bevacizumab administration (participants in Parts D and E)\n5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.\n6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.\n8. Deep venous thromboembolic event within 4 weeks prior to enrollment\n9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.\n10. History of any life-threatening VEGF-related adverse event",{"count":582,"type":22},914,[25],"This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.\n\nParticipants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs.\n\nThis clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.\n\nThis study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body.\n\nThis study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.",[28,586,70,348,587,588],"Carcinoma, Non-Small-Cell Lung","Gastroesophageal Junction Adenocarcinoma","Small Cell Lung Carcinoma",[590,379,376,591,592,593,594],"CRC","GC","GEJ","SCLC","Seattle Genetics","2026-07-21",{"date":597,"type":44},"2026-07-22",{"date":599,"type":44},"2023-11-20",{"date":601,"type":22},"2030-09-12",{"name":603,"class":82},"Seagen, a wholly owned subsidiary of Pfizer",48,{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":618,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":625},"100458748","phase-3-a-study-of-tucatinib-with-trastuzumab-and-mfolfox6-versus-standard-of-care-treatment-in-first-line-her2-metastatic-colorectal-cancer-100458748","NCT05253651","A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer","An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer","MOUNTAINEER-03","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic\n* Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory\n\n  * If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment\n* HER2+ disease as determined by a tissue based assay performed at a central laboratory.\n* Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.\n* Radiographically measurable disease per RECIST v1.1 with:\n\n  * At least one site of disease that is measurable and that has not been previously irradiated, or\n  * If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:\n\n  * No evidence of brain metastases\n  * Previously treated brain metastases which are asymptomatic\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced\u002Funresectable or metastatic setting prior to randomization.\n\n  * Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \\>6 months prior to enrollment\n* Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)\n* Previous treatment with anti-HER2 therapy\n* Ongoing Grade 3 or higher neuropathy\n* Active or untreated gastrointestinal (GI) perforation at the time of screening.",{"count":614,"type":22},400,[184],"This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.\n\nParticipants in this study have colorectal cancer that has spread through the body (metastatic) and\u002For cannot be removed with surgery (unresectable).\n\nParticipants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:\n\n* mFOLFOX6 alone,\n* mFOLFOX6 with bevacizumab, or\n* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.",[28],[36,590,594],{"date":597,"type":44},{"date":621,"type":44},"2022-10-24",{"date":623,"type":22},"2030-07-03",{"name":603,"class":82},366,{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":635,"conditions":636,"keywords":638,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":52},"100647251","a-novel-clinical-decision-support-tool-to-predict-submucosal-invasive-cancer-within-large-non-pedunculated-colorectal-polyps-100647251","NCT07705880","A Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Pedunculated Colorectal Polyps","Multi-centre Evaluation of a Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Pedunculated Colorectal Polyps - A Prospective Study","Inclusion Criteria:\n\nEndoscopist participants\n\n* Gastrointestinal endoscopists of varying abilities and grades\n* Endoscopists who have not previously encountered the clinical decision support tool Patient participants\n* Referred for colonoscopy with appropriate bowel preparation\n* Colorectal polyp \\>=20mm in size detected or referred for resection\n* Non-pedunculated morphology\n* Non-sessile serrated morphology\n* Signed informed consent for the procedure and trial participation\n\nExclusion Criteria:\n\nEndoscopist participants:\n\n* Does not consent to inclusion\n* Does not undergo the learning intervention\n* No connection with endoscopy in gastroenterology\n\nPatient participants:\n\n* Does not consent to data collection for the study\n* Video of inadequate quality as per opinion of the principal investigator",{"count":634,"type":22},886,"Colorectal cancer can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (\\>=20mm) non-pedunculated colorectal polyps (LNPCPs) require careful assessment before treatment. If submucosal invasive cancer (SMI) is present, it determines whether endoscopic treatment can be curative or whether surgery is needed. Current classification systems to detect SMI are complex, require extensive training, and are underused in non-tertiary hospitals.\n\nA simple web-based clinical decision support tool was created using well-established parameters (presence of a demarcated area, polyp size, Paris classification, location, and granularity) to identify SMI within LNPCPs. Crucially, the tool uses only standard endoscopic imaging available in most endoscopy units.\n\nThis prospective multi-centre study evaluates the accuracy of the tool during live endoscopic assessment. Endoscopists of varying experience will assess 10 large colorectal polyps using the tool, then undergo a randomized educational intervention (either a 10-minute instructional video or a 45-minute interactive training session). They will then assess a further 10 polyps using the tool. A third set of 10 assessments at 3 months evaluates durability of learning. Accuracy is compared to expert opinion.",[28,637],"Colonic Polyps",[639,640,641,642,643],"submucosal invasive cancer","Large non-pedunculated colorectal polyps","Clinical decision support tool","Endoscopic assessment","LNPCP","2026-07-10",{"date":646,"type":44},"2026-07-15",{"date":648,"type":44},"2022-10-01",{"date":650,"type":22},"2030-09-30",{"name":652,"class":115},"University Hospital, Ghent",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":660,"targetDuration":4,"studyType":23,"phases":662,"briefSummary":663,"conditions":664,"keywords":674,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":687,"completionDateStruct":688,"leadSponsor":689,"locationsCount":52},"100461298","phase-2-pds01adc-in-combination-with-hepatic-artery-infusion-pump-haip-and-systemic-therapy-for-subjects-with-metastatic-colorectal-cancer-intrahepatic-cholangiocarcinoma-or-metastatic-adrenocortical-carcinoma-100461298","NCT05286814","PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma","* INCLUSION CRITERIA:\n\nInclusion Criteria- All Cohorts\n\n* Participants must have a documented diagnosis of one of the following cancers:\n\n  * Metastatic colorectal cancer (mCRC)\n  * Intrahepatic cholangiocarcinoma (ICC)\n  * Adrenocortical carcinoma (ACC) with liver dominant disease\n* Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:\n\n  * mCRC: FOLFOX or FOLFIRI\n  * ICC: GemOx or FOLFOX\n  * ACC: GemOx\n* Age \\>= 18 years.\n* Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP).\n\nNOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening.\n\n* All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile.\n* Nursing (including breastfeeding) participants must agree to discontinue nursing.\n* Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C\u002FA\u002FP multiphase) amenable to placement of the HAIP.\n* Participant must sign the informed consent form to participate in this study.\n* HIV-positive participants may be considered for this study only if they have an undetectable viral load.\n* Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, \"Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors\".\n* Participant's liver metastases must not be amenable to resection\u002Fablation to No Evidence of Disease (NED) in one stage.\n\nInclusion Criteria-Metastatic Colorectal Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1).\n* Participants must have measurable liver metastatic disease.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \\> 60 mL\u002Fmin\u002F1.73 m2.\n\nInclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.\n* Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection.\n* Participants must have radiographically measurable disease.\n* Disease must be considered unresectable at the time of preoperative evaluation.\n* Participants must have received 1st line systemic chemotherapy.\n* ECOG performance status \\\u003C=1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 2,000\u002F mm\\^3\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\>= 75,000\u002F mm\\^3\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 mg\u002Fdl\n  * creatinine \\\u003C= 1.5 mg\u002Fdl\n\nInclusion Criteria-Adrenocortical Carcinoma\n\n* Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as \"adrenocortical cancer\".\n* Participants must have received at least one line of systemic chemotherapy.\n* Participants must have measurable liver metastatic disease.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\> 3,000\u002FmcL\n  * absolute neutrophil count \\> 1,500\u002FmcL\n  * platelets \\> 90,000\u002FmcL\n  * hemoglobin \\> 8 g\u002FdL\n  * total bilirubin \\\u003C 1.5 X institutional upper limit of normal\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 X institutional upper limit of normal\n  * creatinine \\\u003C 2 X institutional upper limit of normal\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria- All Cohorts\n\nParticipants who are receiving any other investigational agents.\n\n* Participants who have previously received rIL-12.\n* Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:\n\n  * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;\n  * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \\\u003C= 10 mg of prednisone or equivalent per day;\n  * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible.\n* History of organ transplant, except for transplants that do not require immunosuppression.\n* History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).\n* Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke \\\u003C 6 months prior to enrollment, myocardial infarction \\\u003C 6 months prior to enrollment, unstable angina, congestive heart failure (\\>= NYHA III) or serious cardiac arrhythmia requiring medication.\n* All conditions associated with significant necrosis of nontumor-bearing tissues.\n* Esophageal or gastroduodenal ulcers \\\u003C 6 months prior to treatment.\n* Active ischemic bowel disease.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma.\n* Prior radiation to liver.\n* Participants with active Hepatitis B or C infection.\n* Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings).\n* Any condition, including the presence of laboratory abnormalities and\u002For insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n\nExclusion Criteria-Metastatic Colorectal Carcinoma\n\n-Participants with incontrovertible radiographic evidence of disease outside of the colon\u002Frectum (primary) and liver given unlikelihood of benefit from liver-directed therapy.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months.\n* Participants with a history of MSI-high results who need to be treated with check-point inhibitors.\n* Prior treatment with FUDR.\n\nExclusion Criteria-Intrahepatic Cholangiocarcinoma\n\n-Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n\nNote: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminate as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy.\n\n* Prior treatment with FUDR.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n\nExclusion Criteria-Adrenocortical Carcinoma\n\n* Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis).\n* Diagnosis of sclerosing cholangitis.\n* Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment.\n* Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.",{"count":661,"type":22},70,[224],"Background:\n\nOne way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\\\u003CTAB\\>\n\nObjective:\n\nTo see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers.\n\nEligibility:\n\nPeople aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nPregnancy test (if needed)\n\nTumor biopsy (if needed)\n\nElectrocardiogram\n\nComputed tomography (CT) scans\n\nParticipants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.\n\nAll participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.\n\nParticipants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks.\n\nParticipants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.\n\nParticipants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.",[665,666,667,28,36,163,668,164,669,670,671,672,673],"Metastatic Colorectal Cancer (Mcrc)","Intrahepatic Cholangiocarcinoma (Icc)","Intrahepatic Bile Duct Cancer","Bile Duct Neoplasms","Adrenocortical Carcinoma (ACC)","Adrenal Cortical Carcinoma","Adrenal Gland Cancer","Adrenal Gland Neoplasms","Adrenal Cortex Neoplasms",[675,676,677,678,679,680,681,682,683,684],"Unresectable Liver Tumor","SMART System","Response Rates","Progression Free Survival (Pfs)","Patient Survival","Overall Survival (Os)","NHS-IL12","Mcrc","Icc","ACC","2026-07-09",{"date":644,"type":44},{"date":621,"type":44},{"date":146,"type":22},{"name":50,"class":51},{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":279,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":700,"conditions":701,"keywords":717,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":728,"lastUpdatePostDateStruct":729,"startDateStruct":731,"completionDateStruct":733,"leadSponsor":735,"locationsCount":737},"100542405","early-detection-of-advanced-adenomas-and-colorectal-cancer-100542405","NCT06342440","Early Detection of Advanced Adenomas and Colorectal Cancer","A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer","AACRC","Inclusion Criteria:\n\n* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.\n* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.\n* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer syndromes (identified through genetic testing).\n* Inflammatory bowel diseases.\n* Lack of written informed consent.",{"count":699,"type":22},2000,"This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.",[36,28,319,702,703,704,705,706,707,708,709,710,711,712,713,714,715,716],"Colorectal Adenocarcinoma","Colorectal Disorders","Colorectal Dysplasia","Colorectal Cancer Stage I","Colorectal Cancer Stage II","Colorectal Cancer Stage III","Colorectal Cancer Stage IV","Colorectal Neoplasms Malignant","Colorectal Serrated Adenocarcinoma","Colorectal Adenoma With Severe Dysplasia","Colorectal Adenoma With Mild Dysplasia","Colorectal Adenoma With Moderate Dysplasia","Colorectal Adenoma and Carcinoma 1","Colorectal Adenomatous Polyp","Colorectal Adenocarcinoma Metastatic in the Liver",[718,719,720,503,721,534,722,723,724,725,726,727],"Early detection","Micro RNA","miRNA","Machine learning","Incidence","Polypectomy","Screening","Surveillance","Exosome","Vascicles","2026-07-06",{"date":730,"type":44},"2026-07-07",{"date":732,"type":44},"2020-03-15",{"date":734,"type":22},"2028-06-18",{"name":736,"class":115},"City of Hope Medical Center",6,{"id":739,"slug":740,"hasResults":12,"nctId":741,"briefTitle":742,"officialTitle":743,"acronym":744,"eligibilityCriteria":745,"healthyVolunteers":279,"sex":17,"minAge":18,"maxAge":746,"enrollmentInfo":747,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":748,"conditions":749,"keywords":750,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":728,"lastUpdatePostDateStruct":756,"startDateStruct":757,"completionDateStruct":759,"leadSponsor":760,"locationsCount":761},"100542402","early-onset-colorectal-cancer-detection-100542402","NCT06342401","Early Onset Colorectal Cancer Detection","Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer","ENCODE","Inclusion Criteria:\n\n* Stage I, II, III, IV colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50 (EOCRC cases)\n* Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment\n* Colonoscopy-proven cancer-free status at the time of study inclusion (Non-disease controls)\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer syndromes (identified through genetic testing)\n* Inflammatory bowel diseases\n* Lack of written informed consent","50 Years",{"count":614,"type":22},"Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.\n\nThis study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid)",[36,28,702,705,708,706,707,709],[751,752,262,753,372,754,755,503],"Early onset","Young onset","micro-RNA","Cancer of the young","Cancer detection",{"date":730,"type":44},{"date":758,"type":44},"2023-04-15",{"date":734,"type":22},{"name":736,"class":115},13,{"id":763,"slug":764,"hasResults":12,"nctId":765,"briefTitle":766,"officialTitle":767,"acronym":4,"eligibilityCriteria":768,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":769,"targetDuration":4,"studyType":23,"phases":771,"briefSummary":772,"conditions":773,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":774,"lastUpdatePostDateStruct":775,"startDateStruct":776,"completionDateStruct":778,"leadSponsor":780,"locationsCount":781},"100601187","phase-1-a-study-of-jnj-95437446-in-participants-with-advanced-stage-solid-tumors-100601187","NCT07107230","A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors","A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors","Inclusion Criteria:\n\n* Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma\n* Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth factor receptor (EGFR) mutational status for NSCLC and Kirsten rat sarcoma\u002Fneuroblastoma ras viral oncogene\u002Fv-raf murine sarcoma oncogene B1 (KRAS\u002FNRAS\u002FBRAF) mutation status for CRC\n* Have measurable or evaluable disease:\n* Part 1: Either measurable or evaluable disease; Part 2: At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version (v) 1.1\n* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening\n* Participants must have appropriate hematologic, renal, and hepatic function within the required limits\n\nExclusion Criteria:\n\n* Any prior medical history of ILD\u002Fpneumonitis, including pneumonitis from anti-PD-1\u002F PD-L1 antibody or radiation that required systemic steroids\n* Toxicity from prior anticancer therapy that has not resolved to Grade \\\u003C=1\n* Evidence of clinically significant active viral, bacterial, or fungal infection within 7 days before the first dose of study treatment requiring systemic or non-topical treatment\n* History of clinically significant cardiovascular disease within 6 months prior to signing informed consent\n* Participants with prior or concurrent second malignancy cannot be enrolled if prior\u002Fconcurrent malignancy's natural history of treatment is likely to interfere with any safety or efficacy study endpoints",{"count":770,"type":22},380,[25],"The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.",[28],"2026-07-02",{"date":728,"type":44},{"date":777,"type":44},"2025-07-15",{"date":779,"type":22},"2028-04-24",{"name":461,"class":82},10,{"id":783,"slug":784,"hasResults":12,"nctId":785,"briefTitle":786,"officialTitle":787,"acronym":4,"eligibilityCriteria":788,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":789,"targetDuration":4,"studyType":23,"phases":791,"briefSummary":792,"conditions":793,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":774,"lastUpdatePostDateStruct":794,"startDateStruct":795,"completionDateStruct":797,"leadSponsor":799,"locationsCount":800},"100567064","phase-1-a-study-of-jnj-89402638-for-metastatic-colorectal-and-gastric-cancers-100567064","NCT06663319","A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers","A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies","Inclusion Criteria:\n\n* For Part 1 (dose escalation), Part 2 (Arm A \\[JNJ-89402638 monotherapy\\]): Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic\u002Funresectable setting; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic\u002Funresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX\u002Fbevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic\u002Funresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI\u002Fbevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic\u002Funresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic\u002Funresectable setting\n* Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1\n\n  1. Part 1: Must have either measurable or evaluable disease\n  2. Part 2: Must have at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (\\>=) 30 milliliter per minute (mL\u002Fmin) based on modification of diet in renal disease (MDRD) 4-variable formula\n\nExclusion Criteria:\n\n* Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression\n* Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (\\\u003C=)1 (except alopecia, vitiligo, Grade \\\u003C= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary\n* Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment\n* Received glucocorticoids (doses \\>10 mg\u002Fday prednisone or equivalent) within 7 days prior to the first dose of study drug\n* Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment",{"count":790,"type":22},260,[25],"The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.",[28,188],{"date":728,"type":44},{"date":796,"type":44},"2024-10-15",{"date":798,"type":22},"2028-07-19",{"name":461,"class":82},11]