[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-colon-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-colon-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,56,81,106,136,161,183],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100617629","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-anti-tumor-activity-of-cbi-1214-t-cell-engager-in-participants-with-advanced-or-metastatic-mssmsi-l-colorectal-cancer-100617629",false,"NCT07321106","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS\u002FMSI-L Colorectal Cancer","A Phase 1, First-in-human (FIH), Dose-Escalation and Dose-Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic Microsatellite Stable (MSS)\u002FMicrosatellite Instability Low (MSI-L) Colorectal Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Participant with MSS\u002FMSI-L CRC, who has exhausted at least one prior line of standard systemic therapy for their current malignancy.\n* Participant with genomic aberrations, including but not limited to BRAFV600E mutations and HER2 amplifications, for which FDA-approved targeted therapies are available, must:\n\n  * Have received prior treatment with applicable FDA-approved targeted therapies AND\n  * Either have experienced disease progression, be refractory, or be intolerant to directed molecular therapy.\n* Participant able to provide archival tissue sample or fresh biopsy tissue sample\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Participant whose CRC tumor tissues have been identified as dMMR or MSI-H\n* Known history of solid organ or tissue transplant; history of interstitial lung disease or non-infectious pneumonitis.\n* Untreated central nervous system (CNS) metastatic disease.\n* Active autoimmune disease that has required systemic treatment within the past 2 years (participants with hormone replacement therapy for adequately controlled endocrinopathy are allowed in the study).\n* History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.\n* Known seropositive for human immunodeficiency virus, hepatitis B surface antigen, or antibody to hepatitis C virus with confirmatory testing and requiring anti-viral therapy.\n* History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.\n* Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure \\>115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.\n* Congenital long QT syndrome or a corrected QT interval (QTc) ≥480 ms at screening (unless secondary to pacemaker or bundle branch block).\n* Active second primary malignancy within 3 years of Screening other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)\u002FMicrosatellite Instability Low (MSI-L) Colorectal Cancer",[26,27,28,29,30,31,32],"Colorectal Cancer","Colorectal Cancer (CRC)","Colorectal (Colon or Rectal) Cancer","CRC","Metastatic Colon Cancer","Colon Cancer","Advanced Colorectal Cancer",[34,35,36,37,38,39,40,41,42],"Oncology","Solid Tumor","Phase 1","First-in-Human","Dose Escalation","Open-Label","T-Cell Engager","TCE","CartographyBio","RECRUITING","2026-06-09",{"date":46,"type":47},"2026-06-10","ACTUAL",{"date":49,"type":47},"2026-01-15",{"date":51,"type":20},"2029-10",{"name":53,"class":54},"Cartography Biosciences","INDUSTRY",8,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100550398","phase-3-de-scalation-or-switch-of-treatment-according-to-circulating-tumor-dna-variation-after-2-cycles-of-doublet-chemotherapy-plus-targeted-agent-in-metastatic-unresectable-colorectal-cancer-100550398","NCT06446557","De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer","De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer (DIAMOND Study): A Randomized Phase III of PRODIGE Intergroup","DIAMOND","Inclusion Criteria:\n\n* Histologically proven diagnosis of RAS WT or mutant, MSS, BRAFV600E non-mutated colorectal cancer.\n* Left side or rectal cancer\n* An unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.\n* At least one measurable lesion according to RECIST criteria version 1.1.\n* Age ≥ 18 years.\n* ECOG PS ≤ 1\n* Neutrophils ≥ 1.5 x 10\\^9\u002FL, Platelets ≥ 100 x 10\\^9\u002FL, Hb \\> 9 g\u002Fdl.\n* Total bilirubin ≤ 1.5 time the upper-normal limits (UNL) and ASAT (SGOT) and\u002For ALAT (SGPT) ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases.\n* Creatinine clearance \\> 50 mL\u002Fmin or serum creatinine ≤ 1.5 x UNL.\n* The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis.\n* Adequate coagulation function \\[International Normalized Ratio (INR) ≤1.5 and Partial. Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x ULN.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Right side colon cancer\n* First-line chemotherapy +\u002F- biologic agents for mCRC before C1\n* Radiotherapy to any site within 4 weeks before C1\n* Adjuvant oxaliplatin-based treatment completed less than 6 months before relapse.\n* Treatment with any investigational drug within 30 days prior to C1\n* Known allergy to any of the study treatment components.\n* Dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Documented and\u002For symptomatic brain or leptomeningeal metastases.\n* Patient with active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.\n* Uncontrolled or poorly controlled hypertension despite standard medical management.\n* Severe renal or hepatic failure\n* Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to C1\n* Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start.\n* Infection with the human immunodeficiency virus.\n* Symptomatic peripheral neuropathy grade 1 according the NCI CTC.\n* Acute or subacute bowel obstruction or history of chronic diarrhea, which is considered clinically significant in the opinion of the investigator.\n* Chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg\u002Fday) is permitted.\n* Pregnant or lactating women.\n* Patient with active psychiatric illness or social situation that would severely limit compliance with study requirements.",{"count":65,"type":20},408,[67],"PHASE3","Background : In unresectable mCRC, a de-escalation strategy using maintenance or chemotherapy (CT) discontinuation in selected cases is considered as a valid option in non-progressive patients after a first-line induction of doublet CT + targeted agent (TA) (1-7).\n\nIn this context, circulating tumor DNA (ctDNA) is considered very promising to optimize decision making. Indeed, ctDNA harbour the same main alterations of the tumor and has been recognized as biologically relevant to reflect tumor dynamics and therapeutic efficacy (8).\n\nAs reported in mCRC, that early variation of ctDNA during CT may be relevant to predict outcome (9-11). Indeed, patients with a ctDNA decrease from the first (C1) to the third (C3) cycles of CT (∆≥80% or ctDNA\\\u003C0.1 ng\u002Fml at C3) or without ctDNA detectable at C1 and C3 have significant better survival as compared to patients with less decrease or with ctDNA increase (10). ctDNA monitoring had never been prospectively evaluated to guide early adaptation in the treatment strategy in mCRC.\n\nAim: A randomized phase III, open label, strategy trial of the superiority in overall survival (OS) adjusted on quality of life of an early treatment adaptation guided by ctDNA variation versus a standard management in unresectable left-side, MSS-BRAFV600E non-mutated mCRC treated by first-line doublet CT + TA.\n\nPatients and methods :\n\n-Main inclusion criteria will be (i) unresectable left-side and non-pre-treated mCRC (ii) MSS and non-mutated BRAFV600E tumor (iii) at least one measurable lesion (iv) ECOG 0-1 and adequate biological functions for first-line doublet CT + TA (antiEGFR if RAS WT, bevacizumab (BV) if RAS MUT).\n\nRandomization (1:1) between an experimental strategy guided by ctDNA variation with de-escalation (Arm A1 or A2) or switch of treatment (Arm A3) versus standard strategy (Arm B). The analysis of variation of ctDNA from C1-C3 will be centralized and detected using Digital PCR targeting hypermethylation of WIF1\u002FNPY genes (10) in real-time in arm A and in second step in arm B.\n\nRandomization in Arm A: after 4 cycles of doublet + TA, non-progressive patients will be allocated to a strategy according to ctDNA value and variation from C1-C3:\n\nArm A1: CT discontinuation (ctDNA normalization \\\u003C 0.1 ng\u002Fml or ctDNA not detectable) Arm A2 : maintenance with fluoropyrimidine + TA (ctDNA ≥ 0.1 ng\u002Fml and ∆ctDNA≥ 80%).\n\nArm A3 : ctDNA non-responders (∆ctDNA \\\u003C 80% or increase) : switch of CT +\u002F- TA.\n\nRandomisation in Arm B: at least 8 cycles of doublet CT + TA before adaptation of sequence at physician choice.\n\nStatistical considerations : with an expected median OS at 32 months (mean 37.6 months), a mean QoL at 70.0% in first-line mCRC, corresponding to 0.700 x 37.6 = 26.3 QALM or 2.19 QALY (SD 1.18 QALY), 408 patients are required (randomization 1:1) to show a gain of 4 months of quality-adjusted OS (4 QALM or 0.33 QALY) in experimental ctDNA strategy versus standard strategy (5% two-sided type I error rate, 81% power and 1.18 QALY SD).\n\nThe secondary objectives will be:\n\n* To compare strategies (standard vs ctDNA guided) overall and in the subgroups of ctDNA response on 18, 24 and 36-months restricted mean of QoL-adjusted OS, OS, PFS, response rate, toxicity, Quality of Life and cost utility.\n* Bio-collection for further ctDNA analysis. Only cost of samples collection and their transportation to the resource center is requested. Further ancillary analysis will be subject to independent funding requests to evaluate :\n* ctDNA kinetics during the induction and its impact on outcome in overall population and in each arm\n* ctDNA changes between time points during de-escalation arms to determine thresholds of variations predictive of clinical and\u002For radiological progression.\n\nConclusion: DIAMOND is a randomized phase III strategy trial to show the superiority in OS adjusted on quality of life of an early treatment adaptation guided by ctDNA versus a standard management in unresectable left-side, MSS-BRAFV600E non-mutated mCRC treated by first-line doublet CT + TA.",[30],"NOT_YET_RECRUITING","2026-06-05",{"date":44,"type":47},{"date":74,"type":20},"2026-06",{"date":76,"type":20},"2032-06-01",{"name":78,"class":79},"University Hospital, Rouen","OTHER",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100347423","phase-3-identification-and-treatment-of-micrometastatic-disease-in-stage-iii-colon-cancer-100347423","NCT03803553","Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer","Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer","Inclusion Criteria:\n\n* Participants must have histologically confirmed resected Stage III adenocarcinoma of the colon. Any T \\[Tx, T1, T2, T3, or T4-\\], N1-2M0.\n* Participants must have completely resected disease. In patients with tumor adherent to adjacent structures, en block RO resection must be documented.\n* Entire tumor must be in the colon (rectal involvement is excluded).\n* Participants must have completed standard adjuvant chemotherapy per the discretion of the treating physician. Standard therapy includes FOLFOX, CAPOX, or therapy with 5FU analog alone will be permitted if it constitutes appropriate standard therapy in the opinion of the treating physician.\n* Participants must not have received prior neoadjuvant chemotherapy.\n* Age ≥18 years.\n* ECOG performance status ≤1.\n* Life expectancy of greater than 3 months.\n* Participants must have normal organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002F mcL\n  * total bilirubin within normal institutional limits. For patients with Gilbert's syndrome, total bilirubin must be ≤ 2 and documented as elevated indirect bilirubin.\n  * AST(SGOT)\u002FALT(SGPT) ≤3 (AST) or ≤ 3 (ALT) × institutional upper limit of normal\n  * creatinine within normal institutional limits OR\n  * creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal by Cockroft-Gault formula.\n* In order to be eligible for the ctDNA positive cohort, women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG).\n* The effects on the developing human fetus are unknown. For this reason and because 5FU, Capecitabine, Oxaliplatin, Irinotecan, Leucovorin, Nivolumab, and Cetuximab are known to be teratogenic, in order to be eligible for the ctDNA positive cohort, females of child-bearing potential (FOCBP) and males must be willing to abstain from heterosexual activity or use 2 forms of effective contraception (fail rate of less than 1% per year, hormonal or barrier method of birth control) from time of informed consent until 5 months (FOCBP) and 7 months (males) after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women who are not of childbearing potential, ie, who are postmenopausal or surgically sterile as well as azoospermic men, do not require contraception.\n* Participants must have documentation of microsatellite instability status. Testing by NGS, PCR based assessment and Immunohistochemistry (IHC) are acceptable. Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicated dMMR. This may be done locally.\n* Participant's circulating tumor DNA (ctDNA) assay (Guardant Reveal-Guardant Health) must satisfy assay specific quality control metrics to generate a result.\n* In order to be eligible for the ctDNA positive cohort, patient must be ctDNA positive following adjuvant therapy using the CLIA certified Guardant Reveal assay. ctDNA positive will be defined as positive based on having a tumor derived signal in the cfDNA that passes calling threshold (\"ctDNA detected\").\n* Ability to understand and the willingness to sign a written informed consent document.\n\nTrastuzumab and Pertuzumab Specific Inclusion Criteria for HER2 cohort\n\n* HER2 overexpression\u002Famplification as shown by NGS sequencing, IHC\u002FFISH or Tumor with 3+ by IHC or 2+ by IHC and HER2\u002Fcep17 ratio \\>2 by FISH.\n* AST(SGOT) ≤ 1.25 and ALT(SGPT) ≤ 1.25 × institutional upper limit of normal\n* Participants of childbearing potential must use effective contraceptive methods during and for 7 months after the last dose of HER2-targeted therapy\n* History of other malignancies within the 5 years prior to study registration, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin (\\*malignancies occurring more than 5 years prior to study entry are permitted if curatively treated with surgery alone).\n* LVEF ≥ 55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) within 12 weeks of treatment start.\n\nExclusion Criteria:\n\n* Patients who are receiving additional investigational therapy or on another investigational protocol\n* Patients who have confirmed metastatic disease per CT.\n* Patients who are unable to get any standard adjuvant therapy\n* Patients who have received more than 6 months of standard adjuvant therapy at the time of study entry.\n* With the exception of standard of care adjuvant therapy, patient received anticancer therapy including chemotherapy, immunotherapy, or antineoplastic biologic therapy (e.g., cetuximab, bevacizumab etc.), within 30 days prior to start of study treatment.\n* Patients who are MSI-high or have a BRAF V600E mutation are excluded from Arm 1 (FOLFIRI) and Arm 2 (Active Surveillance).\n* Patients with a BRAFV600E mutation and who are MSI-high are excluded from Arm 5 (ENCO\u002FBINI\u002FCETUX).\n* Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* (ctDNA positive cohort only). Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 6 months for woman and 6 months for men, after the last dose of trial treatment.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Has an active infection requiring systemic therapy.\n\nNivolumab Specific Inclusion Criteria for MSI-H Cohort:\n\n* Must have documentation of microsatellite instability status. NGS, PCR based assessment and Immunohistochemistry (IHC) are acceptable. Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicated dMMR. This may be done locally.\n* Patients must have detectable ctDNA (Guardant Reveal assay) post standard adjuvant therapy in order to be in this cohort.\n\nNivolumab Specific Exclusion Criteria for MSI-H Cohort:\n\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other forms of immunosuppressive therapy within 7 days prior to the first dose of nivolumab treatment. Subject requiring systemic steroids are excluded from the trial. The use of physiologic doses of corticosteroids may be approved after discussion with the sponsor.\n* Has a known history of active TB (Bacillus tuberculosis)\n* Hypersensitivity to nivolumab or any of is excipients\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Patients that require supplemental oxygen are excluded.\n* Patients who are known HIV+ positive are eligible if their CD4+ count is ≥ 350\u002FμL for at least 3 months and they have an undetectable viral load. In addition, patient must be currently receiving Highly Active Antiretroviral Therapy (HAART) and have been on therapy for at least 3 months prior to study entry, under the care of an Infectious Diseases specialist. Patients should have no history of an AIDS-defining opportunistic infection.\n* Patients known hepatitis B and hepatitis C must be under the care of viral hepatitis expert consultant. Patients with hepatitis B are required to be treated with anti-HBV treatment (e.g., entecavir) and have an HBV viral load \\\u003C100 IU\u002FmL. Patients with hepatitis C need to have received prior and\u002For ongoing hepatitis C treatment.\n* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n\nEncorafenib, binimetinib, and cetuximab Specific Inclusion Criteria for BRAF mutant Cohort\n\n* Presence of BRAFV600E in tumor tissue previously determined by IMPACT at any time prior to Screening.\n* Patients must have detectable ctDNA (Guardant Health LUNAR assay) post standard adjuvant therapy in order to be in this cohort.\n* Participants must have normal organ, marrow, and hematologic function as defined below:\n\n  * Hemoglobin ≥9 g\u002FdL (5.58 mmol\u002FL)\n  * Total bilirubin ≤ 1.5 (25.65 μmol\u002FL)\n  * Platelets ≥100,000\u002FμL\n\nEncorafenib, binimetinib, and cetuximab Specific Exclusion Criteria for BRAF V600E mutant Cohort:\n\n* Patients with a BRAFV600E mutation and who are MSI-H are excluded from Arm 5 (ENCO\u002FBINI\u002FCETUX)\n* Prior therapy with a BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib) and\u002For a MEK inhibitor (e.g., binimetinib, trametinib, cobimetinib).\n* Known hypersensitivity or contraindication to any component of binimetinib or encorafenib or their excipients.\n* The patient has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, or has red meat allergy or tick bit history.\n* Inability to swallow and retain study drug.\n* Participants who have undergone major surgery (e.g., in-patient procedures) ≤ 6 weeks prior to start of study treatment or who have not recovered from side effects of such procedure.\n* Participants who have had radiotherapy ≤ 14 days prior to start of study treatment or who have not recovered from side effects of such procedure. Note: Palliative radiation therapy must be complete 7 days prior to the first dose of study treatment.\n* Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment.\n\nNote: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll.\n\n* Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:\n\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) \\\u003C 6 months prior to Screening;\n  * Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);\n  * Left ventricular ejection fraction (LVEF) \\\u003C 50% as determined by MUGA or ECHO;\n  * Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy;\n  * History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);\n  * Triplicate average baseline QTc interval ≥ 480 ms.\n* Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drug (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, small bowel resection with decreased intestinal absorption), or recent (≤ 3 months) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs.\n* Known history of acute or chronic pancreatitis.\n* Concurrent neuromuscular disorder that is associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* History or current evidence of RVO or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease.\n* Current use of a prohibited medication (including herbal medications, supplements, or foods), as described in Section 5.5, or use of a prohibited medication ≤ 1 week prior to the start of study treatment.\n* History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli.\n\nNote: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks.\n\nNote: Patients with thromboembolic events related to indwelling catheters or other procedures may be enrolled.\n\n* Concurrent or previous other malignancy within 2 years of study entry, except adequately treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease and Gleason 6 prostate cancer.\n* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n* Evidence of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection. Note: Patients with laboratory evidence of cleared HBV or HCV infection may be enrolled.\n\nNote: Patients with no prior history of HBV infection who have been vaccinated against HBV and who have a positive antibody against hepatitis B surface antigen as the only evidence of prior exposure may be enrolled.\n\nTrastuzumab and Pertuzumab Specific Exclusion Criteria for HER2 cohort\n\n* Serious cardiac illness or medical conditions including but not confined to:\n\n  * History of NCI CTCAE v5.0 Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class ≥ II\n  * High-risk uncontrolled arrhythmias ie, atrial tachycardia with a heart rate ≥ 100\u002Fmin at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 \\[Mobitz 2\\] or third degree AV-block)\n  * Serious cardiac arrhythmia or severe conduction abnormality not controlled by adequate medication\n  * Angina pectoris requiring anti-anginal medication.\n  * Evidence of myocardial infarction within 12 months prior to enrollment\n  * Clinically significant valvular heart disease\n  * Evidence of transmural infarction on electrocardiogram (ECG)\n  * Poorly controlled hypertension (eg, systolic \\> 180 mm Hg or diastolic \\> 100 mm Hg).\n  * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction \\[LVSD\\], left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome\n* High risk patients who have received chemoprevention drugs in the past are not allowed to enroll in the study.\n* Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy and immunotherapy.\n* Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions\u002Fillness (e.g., infections or poorly controlled diabetes).",{"count":89,"type":20},400,[67],"This research study is comparing two standard of care treatment options based on blood test results for participants who have metastatic colon cancer.\n\nThe names of the potential treatments involved in this study are:\n\n* Active surveillance\n* FOLFIRI treatment\n* Nivolumab treatment\n* Encorafenib\u002FBinimetinib\u002FCetuximab treatment\n* Trastuzumab + Pertuzumab",[30,93],"Stage III Colon Cancer",[95,93],"Metastatic colon Cancer","2026-04-27",{"date":98,"type":47},"2026-05-01",{"date":100,"type":47},"2020-04-16",{"date":102,"type":20},"2027-12",{"name":104,"class":79},"Massachusetts General Hospital",3,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":4},"100587511","xdrive-in-metastatic-colorectal-cancer-100587511","NCT06929338","xDRIVE in Metastatic Colorectal Cancer","A Feasibility Study to Evaluate a Precision Oncology Platform (xDRIVE) in Participants With Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Participants (men and women) enrolled in internal review board (IRB) 622-00 and meet the following criteria.\n* Participants ≥18 years of age with a diagnosis of mCRC who are willing to consent to the study\n* Participants with Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2.\n* Participants with measurable disease\n* Participants who need to start SOC cancer-directed systemic therapy\n* Participants able to provide treatment and outcome information from previous lines of therapy.\n* Participants who will need a tumor biopsy, excision, or resection as part of their routine clinical care.\n* Participants willing to have a blood draw performed for matched normal material.\n* Participants who plan to have their first radiographic assessment of their cancer at Mayo Clinic.\n\nExclusion Criteria:\n\n* Participants who do not have malignant tissue available or safely accessible or do not have sufficient amount of tissue from anticipated biopsy, excision or resection for testing.\n* Participants who do not have measurable disease.\n* Participants with insufficient health indicators to undergo therapeutic intervention for mCRC based on treating oncologist's clinical assessment.\n* Participants with other concurrent cancers besides mCRC which also require ongoing cancer-directed therapy.\n* Participants who cannot provide an informed consent.",{"count":114,"type":20},30,"OBSERVATIONAL","The study aims to evaluate the clinical utility of the xDRIVE functional precision medicine + artificial intelligence (AI) platform in predicting treatment response for metastatic colorectal cancer (mCRC). The primary objective is to assess xDRIVE's accuracy in forecasting clinical benefit from standard-of-care (SOC) therapies, with a target of ≥80% accuracy in 25 participants. Achieving this threshold would provide sufficient statistical power to reject the null hypothesis of ≤50% accuracy.\n\nThe secondary goal is to determine the feasibility of utilizing xDRIVE for timely treatment recommendations. Success will be defined by the ability to provide recommendations within four weeks for at least 64% of patients, ensuring clinical applicability.\n\nAdditionally, the study includes an exploratory objective to examine oncologists' perspectives on integrating xDRIVE into clinical decision-making. This will be achieved through a post-hoc survey assessing physician experiences with the precision oncology platform.",[118,30,119,120,121],"Metastatic Colon Adenocarcinoma","Metastatic Rectal Adenocarcinoma","Metastatic Rectal Carcinoma","Metastatic Rectum Cancer",[123,124,125,126],"functional precision medicine","artificial intelligence","molecular tumor profiling","metastatic colorectal cancer","2025-09-10",{"date":129,"type":47},"2025-09-16",{"date":131,"type":20},"2025-09-15",{"date":133,"type":20},"2027-06-30",{"name":135,"class":54},"First Ascent Biomedical Inc.",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":80},"100531621","exercise-for-gut-microbiome-in-patients-with-young-onset-colorectal-cancer-undergoing-chemotherapy-the-courage-trial-100531621","NCT06202183","Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial","Inclusion Criteria:\n\n* Patient diagnosed with early-stage or metastatic colon or rectal cancer\n* Age at diagnosis 18-50 years; due to the specificity of the study question those outside the age bracket will not be included\n* No plans for major surgical intervention at the time of recruitment for a minimum of 12 weeks (i.e. study period; placement of port a cath is allowed)\n* No plans for radiation therapy at the time of recruitment for a minimum of 12 weeks\n* On or planning chemotherapy\n* Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week\n* Medical clearance to perform exercise intervention and testing by their treating oncologist\n* No uncontrolled medical conditions that could be exacerbated with exercise\n* Ability to communicate and complete written forms in English\n* Ability to understand and the willingness to sign informed consent prior to any study-related procedures\n* Willing to travel to DFCI for necessary data collection\n\nExclusion Criteria:\n\n* Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects.\n* Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.\n* Patients actively on a weigh loss diet and\u002For actively taking weight loss drugs. This could effect gut microbiome.\n* Patient with other active malignancies (excluding basal cell carcinoma).\n* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.","50 Years",{"count":144,"type":20},84,[146],"NA","This research study is a randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer.\n\nThe names of the study groups involved in this study are:\n\n* Exercise\n* Waitlist Control",[26,30,149],"Metastatic Colorectal Cancer",[26,30,149,151],"Early Stage Colorectal Cancer","2025-08-14",{"date":154,"type":47},"2025-08-15",{"date":156,"type":47},"2024-07-22",{"date":158,"type":20},"2027-07-31",{"name":160,"class":79},"Dana-Farber Cancer Institute",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100504470","phase-1-a-phase-1-2-of-st316-with-selected-advanced-unresectable-and-metastatic-solid-tumors-100504470","NCT05848739","A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors","A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Able and willing to sign an informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein.\n2. Male or female ≥18 years of age.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n4. Must have a locally advanced or metastatic inoperable tumor as follows:\n\n   1. For the dose-escalation phase: CRC, HCC, TNBC, NSCLC, OC, melanoma, CCA, and SS.\n   2. For the expansion phase: CRC. Note: if additional indications and combinations are added inclusion\u002Fexclusion criteria will be updated.\n5. Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the Investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated, but a new or progressing lesion in the radiation field is acceptable. Subjects without accessible lesion for biopsy must be able to provide an archival tumor tissue sample for central lab analysis.\n6. In the Investigator's opinion, the subject may not derive clinical benefit from, or is ineligible for, a particular form of standard therapy on medical grounds, or the subject failed or did not tolerate one or more of other anticancer therapies:\n\n   a. For the dose escalation phase: i. Refractory, intolerant, or refused available standard-of-care therapies. ii. Up to three previous lines of systemic anticancer therapies for metastatic disease are allowed (adjuvant or neoadjuvant setting do not count as lines of systemic therapy).\n\niii. Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to Food and Drug Administration (FDA) approved treatments prior to enrolling in this study (e.g., iPARP).\n\niv. Subjects with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll.\n\nv. Subjects with CRC tumors that are MSI-H\u002FdMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).\n\nvi. Subjects with HCC must have confirmed diagnosis of inoperable hepatocellular carcinoma by histology or clinical\u002Fradiological criteria. No more than two prior lines of systemic therapy only and Child Pugh Score A or B7.\n\nb. For the expansion phase: i. For all cohorts: Subjects with MSI-H\u002FdMMR must have received, refused or be intolerant to a CPI.\n\nii. Cohort 1 ST316 monotherapy: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of four prior lines of therapy for their advanced\u002Fmetastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-vascular-endothelial growth factor (VEGF), anti-epidermal growth factor receptor (EGFR) targeted agents (as indicated).\n\niii. Cohort 2: Combination with standard of care (SOC) FOLFIRI + bevacizumab: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of one prior line of therapy for their advanced\u002Fmetastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF. Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.\n\niv. Cohort 3: Combination with fruquintinib: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of two prior lines of therapy for their advanced\u002Fmetastatic disease: oxaliplatin, irinotecan, fluoropyrimidines or anti-VEGF Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first or second line of treatment.\n\nv. Cohort 4: Combination with Lonsurf + beva: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of two prior lines of therapy for their advanced\u002Fmetastatic disease: oxaliplatin, irinotecan, fluoropyrimidines or anti-VEGF Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first or second line of treatment.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to ST316 or any of its excipients.\n2. Known hypersensitivity to bevacizumab, 5-FU, leucovorin or irinotecan for Cohort 2, to fruquintinib for Cohort 3 and trifluridine or tipiracil for Cohort 4 in the expansion.\n3. Corrected interval between Q and T wave on electrocardiogram (ECG) (QTc) \\> 480 msec using Fredericia's formula.\n4. Symptomatic ascites or pleural effusion. A subject who is clinically stable for 4 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.\n5. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to study entry and have no evidence of new or enlarging brain metastases. Subjects with treated brain metastases must also follow the steroid exclusion criterion (#11) listed below.\n6. For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study.\n7. For subjects to be treated with a regimen containing bevacizumab:\n\n   1. History of cardiac disease: congestive heart failure (CHF) ≥NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (βeta blockers or digoxin are permitted).\n   2. Current uncontrolled hypertension (systolic blood pressure \\[BP\\] \\>150 mmHg or diastolic pressure \\>90 mmHg despite optimal medical management) as well as prior history of hypertensive crisis or hypertensive encephalopathy.\n   3. History of arterial thrombotic or embolic events (within 6 months prior to study entry).\n   4. Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease).\n   5. Evidence of bleeding diathesis or clinically significant coagulopathy.\n   6. Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the course of the study as well as minor surgical procedure (excluding placement of a vascular access device or bone marrow biopsy) within 7 days prior to study enrollment.\n   7. Proteinuria at screening as demonstrated by urinalysis with proteinuria ≥2+ (subjects discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤1g of protein in 24 hours to be eligible).\n   8. History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intraabdominal abscess within 6 months.\n   9. Ongoing serious, non-healing wound, ulcer, or bone fracture.\n   10. History of reversible posterior leukoencephalopathy syndrome (RPLS).\n   11. History of hypersensitivity to Chinese hamster ovary (CHO) cells or other human or humanized recombinant antibodies.\n\n       \\-",{"count":169,"type":20},130,[23],"This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT\u002Fβ-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation\u002Fregimen exploration phase and a phase 2 expansion phase.",[31,30],"2025-05-06",{"date":175,"type":47},"2025-05-11",{"date":177,"type":47},"2023-06-05",{"date":179,"type":20},"2027-05-31",{"name":181,"class":54},"Sapience Therapeutics",11,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":191,"targetDuration":193,"studyType":115,"phases":4,"briefSummary":194,"conditions":195,"keywords":202,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":80},"100494126","liver-embolization-approaches-for-tumor-management-100494126","NCT05714124","Liver Embolization Approaches for Tumor Management","Liver Embolization Approaches for Tumor Management - Retrospective and Prospective Analysis of the Short-, Medium-, and Long-term Clinical Course of Patients Subjected to Embolization Treatment for Primary and Secondary Liver Neoplasms","LEATUM","Inclusion Criteria:\n\n* ≥ 18 yoa\n* patients with patients with primary or secondary liver disease not amenable for surgery or ablation\n* patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy\n* able and willing to sign informed consent\n\nExclusion Criteria:\n\n* pregnant women\n* patients with uncorrectable coagulopathy\n* diffuse extrahepatic disease\n* for lobar TACE and TARE - presence of bilodigestive shunt\n* for TARE - \\>20% hepatopulmonary shunt",{"count":192,"type":20},580,"5 Years","The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.",[196,197,30,198,199,200,201],"Hepatocellular Carcinoma","Cholangiocarcinoma","Metastatic Cancer","Metastatic Gastric Cancer","Primary Liver Cancer","Metastatic Pancreatic Cancer",[203],"embolization, TAE, TACE, TARE, PVE, HVE","2024-04-11",{"date":206,"type":47},"2024-04-12",{"date":208,"type":47},"2021-05-21",{"date":210,"type":20},"2031-12-31",{"name":212,"class":79},"IRCCS San Raffaele"]