[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crc":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,54,81,137,171,196,227,254,280,303,323,351,381,401,441,464,487,509,532],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100623492","phase-1-study-of-rason-inhibitors-in-combination-with-ivonescimab-in-patients-with-solid-tumors-100623492",false,"NCT07397338","Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors","A Phase 1\u002F2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.\n* Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration).\n* Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \\& B for Part 2 Dose Expansion).\n* Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).\n* Measurable disease per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Head and neck squamous cell carcinoma.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 4 weeks prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Other inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},370,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.",[27,28,29,30,31,32],"Advanced Solid Tumors","Metastatic Solid Tumors","Non-small Cell Lung Cancer (NSCLC)","NSCLC","Colorectal Cancer (CRC)","CRC",[27,28,34,30,35,32,36,37,38,39,40],"Non-small Cell Lung Cancer","Colorectal Cancer","RAS","NRAS","KRAS","HRAS","RAS Mutation","RECRUITING","2026-06-26",{"date":44,"type":45},"2026-06-29","ACTUAL",{"date":47,"type":45},"2026-01-30",{"date":49,"type":20},"2029-05",{"name":51,"class":52},"Revolution Medicines, Inc.","INDUSTRY",6,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100642009","a-study-of-a-urine-test-to-detect-colorectal-cancer-100642009","NCT07649057","A Study of a Urine Test to Detect Colorectal Cancer","Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa","Inclusion Criteria:\n\n* Patient presents with one of the following:\n\n  * Patients with symptoms of CRC (such as rectal bleeding for a week) -OR-\n  * Patients who present for a screening colonoscopy -OR-\n  * Has received one of the following within 3 weeks of the planned urine collection\n\n    * Patients with a pathologic diagnosis of CRC either by colonoscopy or resection specimens -OR-\n    * Patients with colonoscopy demonstrating adenomatous polyps -OR-\n    * Patients with colonoscopy demonstrating no colon or premalignant or malignant pathology\n* Age ≥ 18\n* Willingness to participate in the study",{"count":62,"type":20},210,"OBSERVATIONAL","The purpose of this study is to find out whether a urine test can detect colorectal cancer (CRC) and precancerous polyps in participants living in Ghana, Tanzania, and South Africa.",[35,66,67,32],"Precancerous Polyp","Rectal Bleeding",[35,66,67,69,32,70,71],"Symptoms of Colorectal Cancer","Memorial Sloan Kettering Cancer Center","26-187","2026-06-11",{"date":74,"type":45},"2026-06-15",{"date":72,"type":45},{"date":77,"type":20},"2028-06-11",{"name":70,"class":79},"OTHER",4,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":111,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100520064","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-mesothelin-targeting-logic-gated-car-t-in-participants-with-solid-tumors-that-express-msln-and-have-lost-hla-a02-expression-100520064","NCT06051695","A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","EVEREST-2","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion",{"count":90,"type":20},474,[23,24],"The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose",[94,35,30,95,96,97,98,99,100,32,101,102,103,104,105,106,107,108,109,110],"Solid Tumor, Adult","Non Small Cell Lung Cancer","NSCLC, Recurrent","Non-Small Cell Squamous Lung Cancer","Pancreas Cancer","Pancreatic Neoplasm","Colorectal Adenocarcinoma","Colon Cancer","Rectal Cancer","Cancer","Ovarian Cancer","Ovarian Neoplasms","Mesothelioma","Mesothelioma, Malignant","Ovary Cancer","Lung Cancer","MESOM",[112,113,114,115,116,117,118,119,120,121,122,123,103,124,32,35,109,30,125,110,104,106,126],"CAR T Cell","Solid Tumors","Autologous","T Cell","Mesothelin","MSLN","HLA-A2","Solid Tumors expressing MSLN","Pancreatic","Cell Therapy","Gene Therapy","blocker","PANC","OVCA","Logic-gate","2026-06-10",{"date":129,"type":45},"2026-06-12",{"date":131,"type":45},"2024-04-03",{"date":133,"type":20},"2029-06",{"name":135,"class":52},"A2 Biotherapeutics Inc.",12,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"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","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",{"count":145,"type":20},80,[23],"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",[35,31,149,32,150,101,151],"Colorectal (Colon or Rectal) Cancer","Metastatic Colon Cancer","Advanced Colorectal Cancer",[153,154,155,156,157,158,159,160,161],"Oncology","Solid Tumor","Phase 1","First-in-Human","Dose Escalation","Open-Label","T-Cell Engager","TCE","CartographyBio","2026-06-09",{"date":127,"type":45},{"date":165,"type":45},"2026-01-15",{"date":167,"type":20},"2029-10",{"name":169,"class":52},"Cartography Biosciences",8,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":16,"minAge":17,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100638801","noninvasive-early-diagnosis-of-colorectal-cancer-using-odor-targeted-capture-point-of-care-testing-and-intelligent-analysis-100638801","NCT07620743","Noninvasive Early Diagnosis of Colorectal Cancer Using Odor-Targeted Capture, Point-of-Care Testing, and Intelligent Analysis","Key Technology Research on Non-invasive Early Diagnosis of Colorectal Cancer Based on Odor-targeted Capture, Instant Detection, and Intelligent Analysis","Inclusion Criteria:\n\n* Age 18 to 85 years, male or female\n* Histopathologically or cytologically confirmed colon or rectal cancer (TNM stage I-IV) for colorectal cancer group\n* Histopathologically confirmed adenomatous polyps, sessile serrated lesions, traditional serrated adenomas, or other precancerous lesions for precancerous lesion group\n* No abnormality on colonoscopy within the past year; no personal history of colorectal cancer or other malignancies; no chronic diseases requiring long-term treatment for healthy control group\n* Willing and able to provide signed informed consent\n\nExclusion Criteria:\n\n* Hereditary colorectal cancer syndromes (e.g., familial adenomatous polyposis, hereditary non-polyposis colorectal cancer)\n* Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis)\n* Severe cardiovascular, respiratory, or urinary system diseases\n* Other primary malignant tumors\n* Hematological diseases\n* Unable to comply with study procedures (e.g., sample collection or questionnaires)\n* Planning to become pregnant, pregnant, or breastfeeding\n* Suspected or confirmed alcohol or drug abuse\n* Known allergy to any drug used for colorectal cancer treatment\n* Participation in another interventional drug clinical trial within the past month\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study",true,"85 Years",{"count":181,"type":20},453,"The goal of this observational study is to see whether a new, noninvasive test that analyzes smells (odor) from breath and intestinal gas can help detect colorectal cancer and precancerous growths at an early stage.\n\nThe main questions it aims to answer are:\n\nCan the new odor-based test correctly identify people who have colorectal cancer or precancerous lesions?\n\nHow accurate is the new test compared to the current standard method (colonoscopy with biopsy)?\n\nResearchers will compare the results of the new test with standard diagnostic results.\n\nParticipants will be asked to:\n\nProvide samples of breath, urine, stool, and intestinal gas (collected using a special device or a collection bag)\n\nAllow researchers to review their medical records and colonoscopy results\n\nAnswer questions about their health history and lifestyle\n\nThis study involves no treatments or procedures beyond normal medical care. It only collects samples and data for research purposes.",[32,184,185],"Precancerous Condition","Healthy","NOT_YET_RECRUITING","2026-05-29",{"date":189,"type":45},"2026-06-02",{"date":127,"type":20},{"date":192,"type":20},"2029-12-31",{"name":194,"class":79},"Beijing University of Chinese Medicine",1,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":206,"conditions":207,"keywords":214,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100437810","solid-tumor-analysis-for-hla-loss-of-heterozygosity-loh-and-apheresis-for-car-t--cell-manufacturing-100437810","NCT04981119","Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing","An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing","BASECAMP-1","Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria\n\n1\\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n\nPart 1: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n\nPart 2 : Key Inclusion Criteria\n\n1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n2. Participants are germline HLA-A\\*02 heterozygous confirmed by HLA typing.\n3. Primary tumor tissue showing LOH of HLA-A\\*02 by NGS testing.\n4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.\n\nPart 2: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.\n5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).\n6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.\n7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.",{"count":205,"type":20},200,"Objective:\n\nTo collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.\n\nDesign:\n\nThis is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.",[94,35,95,208,32,30,98,106,104,105,209,107,210,103,211,212,213],"Pancreatic Cancer","Ovarian Carcinoma","Mesothelioma; Lung","Triple Negative Breast Cancer (TNBC)","Renal Cell Carcinoma (Kidney Cancer)","Head and Neck Squamous Cell Carcinoma HNSCC",[215,216,217,218,219],"CAR T Cell Therapy","Next Generation Sequencing","Leukapheresis","Apheresis","Immunotherapy",{"date":189,"type":45},{"date":222,"type":45},"2021-10-29",{"date":224,"type":20},"2029-04",{"name":135,"class":52},16,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":21,"phases":236,"briefSummary":237,"conditions":238,"keywords":243,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100619816","phase-1-study-of-rmc-5127-in-patients-with-advanced-kras-g12v-mutant-solid-tumors-100619816","NCT07349537","Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.\n* Measurable per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and\u002For inhibitors).\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":235,"type":20},574,[23],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.",[29,31,239,240,241,32,30,208,242,27],"Pancreatic Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","PDAC","Lung Cancer (NSCLC)",[27,208,244,241,35,32,109,34,30,36,38,40],"Pancreatic Ductal Adenocarcinoma","2026-05-28",{"date":247,"type":45},"2026-06-01",{"date":249,"type":45},"2026-01-08",{"date":251,"type":20},"2028-10",{"name":51,"class":52},5,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":269,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":226},"100566595","phase-1-first-in-human-study-of-tub-030-in-patients-with-advanced-solid-tumors-100566595","NCT06657222","First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","A Multicenter FIH Dose Escalation and Optimization Phase I\u002FIIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female aged 18 years or older\n2. Adequate organ function\n3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1\n4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.\n5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.\n6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.\n7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.\n8. Eastern Cooperative Oncology Group (ECOG) 0-1.\n9. Have a life expectancy of \\>12 weeks for disease-related mortality, as evaluated by the INV.\n10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent\n11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n\\-",{"count":262,"type":20},250,[23,24],"The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:\n\nTo determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.\n\nParticipants will:\n\nReceive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms",[27,266,267,30,268,32],"HNSCC","SCLC","TNBC - Triple-Negative Breast Cancer",[27,30,270],"Head and Neck Cancer","2026-05-22",{"date":273,"type":45},"2026-05-27",{"date":275,"type":45},"2024-12-13",{"date":277,"type":20},"2028-12",{"name":279,"class":52},"Tubulis GmbH",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100572039","phase-2-addition-of-antibiotics-to-upfront-treatment-regimen-for-colorectal-cancer-100572039","NCT06728072","Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer","Pilot Study Evaluating Microbiome Modulation Therapy (MBMT) With Ciprofloxacin, Metronidazole, and Aspirin in Addition to Standard of Care Chemotherapy in Patients Undergoing First-Line Therapy for Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Diagnosis of stage IV colorectal cancer\n* Measurable disease by Response evaluation criteria in solid tumors (RECIST) 1.1 criteria\n* Planned first-line treatment with a 5FU-based doublet chemotherapy regimen for colon cancer, specifics of the regimen at the discretion of the treating physician Note: Patients who have received adjuvant therapy \\>6 months prior are eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Absolute neutrophil count (ANC) ≥1,500 cells\u002FμL\n* Platelet count ≥100,000 cells\u002FμL\n* Hemoglobin ≥8 g\u002FdL Note: The use of transfusion or other intervention to achieve hemoglobin ≥8 g\u002FdL is acceptable.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) Note: Patients with documented liver metastases: AST and ALT ≤5 × ULN\n* Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥40 mL\u002Fmin using the Cockcroft-Gault equation: (140 - age) × body weight\u002Fplasma creatinine × 72 (× 0.85 if female)\n* Radiographically measurable disease by RECIST 1.1\n* Nonpregnant and not actively breastfeeding\n* Sexually active patients of childbearing potential and their partners must agree to use medically acceptable form of contraception, per treating investigator, throughout the study Patients should continue to use medically acceptable methods of contraception after study treatment ends, following the guidance for their specific chemotherapy regimen.\n\nChildbearing potential excludes:\n\nAge \\> 50 years and naturally amenorrhoeic for \\> 1 year OR previous hysterectomy or bilateral salpingo-oophorectomy\n\n* Patients on a pre-existing daily aspirin regimen may participate in the study without interrupting this regimen.\n* Patients with a contraindication to aspirin may participate in the study. These patients will not be required to take aspirin as part of the study treatment.\n\nExclusion Criteria:\n\n* Total colectomy\n* Diagnosed with Cockayne Syndrome\n* Using disulfiram, tizanidine, or theophylline and unable to stop taking these medications for the length of the microbiome modulation therapy\n* On methotrexate doses of 15 mg\u002Fweek or more\n* History of allergic reaction to ciprofloxacin, metronidazole, or aspirin\n* Fuss course of antibiotics in the 30 days before chemotherapy start Note: Full course is defined as ≥5 doses with an intent to treat a defined infection. Use of antibiotics intended for prophylaxis at the time of surgery is allowed\n* Corrected QT interval (QTc) \\>480 on baseline ECG\n* Diagnosed with a malabsorptive syndrome\n* Inability to swallow tablets",{"count":288,"type":20},97,[24],"This is a 2-arm, noncomparative phase 2 trial designed to evaluate treatment outcomes with or without the addition of ciprofloxacin, metronidazole, and aspirin to first-line chemotherapy for patients with stage IV colorectal cancer (CRC).",[35,32],[35,32],"2026-05-05",{"date":295,"type":45},"2026-05-06",{"date":297,"type":45},"2025-03-07",{"date":299,"type":20},"2035-07-01",{"name":301,"class":79},"Virginia Commonwealth University",2,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":21,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":321,"locationsCount":195},"100614728","phase-1-a-phase-ibii-trial-of-hs-20110-combination-therapies-in-advanced-colorectal-cancer-patients-100614728","NCT07283367","A Phase Ib\u002FII Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 Combination Therapies in Patients With Advanced Colorectal Cancer.","Inclusion Criteria:\n\n* Males or females, aged ≥ 18 years.\n* Participants with pathologically confirmed advanced Colorectal Cancer.\n* Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.\n* MSI was tested to be non-MSI-H, and without BRAF V600E mutation.\n\nExclusion Criteria:\n\n* Participants have received or are receiving the following treatment:\n\n  1. Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.\n  2. Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.\n  3. Major surgery within 4 weeks prior to the first dose of study treatment.\n  4. Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.\n  5. Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded.\n  6. Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.\n* Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).\n* Inadequate bone marrow reserve or hepatic and renal functions.\n* Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.\n* Participants who are allergic to any component of HS-20110 combination therapies.",{"count":311,"type":20},502,[23,24],"This is a multicenter, open-label Phase Ib\u002FII clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of the HS-20110 combination therapies in Patients with Advanced Colorectal Cancer. \"Rolling 6\" design would be used to conduct dose escalation part of this study. This study consists of phase Ib and phase II. After RP2D was determined in phase Ib, then a phase II study will be conducted to further evaluate the efficacy, safety, tolerability, and PK of the HS-20110 combination therapies in Patients with mCRC.",[32],"2026-04-27",{"date":317,"type":45},"2026-05-01",{"date":319,"type":45},"2025-12-22",{"date":192,"type":20},{"name":322,"class":52},"Hansoh BioMedical R&D Company",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":21,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":349,"locationsCount":195},"100622260","phase-2-oncolytic-virus-h101--sbrt--chemotherapy--targeted-therapy--immunotherapy-for-unresectable-crlm-100622260","NCT07381309","Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM","Oncolytic Virus (H101) Peritumoral Injection Combined With SBRT, Chemotherapy, Targeted Therapy, and Immunotherapy for Unresectable MSS\u002FpMMR Colorectal Cancer Liver Metastases (CRLM)","VVSHIP","Inclusion Criteria:\n\n1. The patient or their legal representative understands and signs the informed consent form.\n2. Patients with pMMR\u002FMSS colorectal adenocarcinoma.\n3. Aged 18-75 years.\n4. Patients with histologically or cytologically confirmed colorectal cancer liver metastases. There must be at least one injectable lesion in the liver, which must also meet the criteria for a measurable target lesion according to RECIST version 1.1 (≥10 mm in the longest diameter on spiral CT\u002FMRI scan with a slice thickness of no greater than 5 mm).\n5. Patients with definitively unresectable metachronous liver metastases; OR patients deemed surgically resectable but who refuse surgery, provided the liver metastases meet the following requirements: ① The number of metastatic lesions must be no more than 5, and the sum of the longest diameters of all metastatic lesions must be ≤100 mm; ② The longest diameter of a single lesion must be ≤100 mm; ③ The longest diameter of the lesion to be injected must be ≥10 mm and ≤80 mm.\n6. The liver metastases have not received prior radiotherapy, OR the area of the liver near the planned radiotherapy site has not been previously irradiated. At least 700 cc of liver volume must be preserved outside the treatment area.\n7. Prior treatments such as hepatic resection, systemic chemotherapy, local ablation therapy, or hepatic artery infusion pump chemotherapy are allowed, provided a washout period of 2 weeks is observed. Patients must have recovered from prior anti-tumor therapy-related adverse events to baseline or Grade ≤1 (according to CTCAE version 5.0) (excluding alopecia and Grade 2 anemia).\n8. Child-Pugh score A or B\n9. ECOG Performance Status 0-1\n10. Peripheral blood counts and liver\u002Frenal function within the allowable ranges (tested within 15 days before treatment initiation)\n11. No prior history of other concomitant malignancies. Patients must not be pregnant or breastfeeding and should use effective contraception during the study and for 6 months after the last dose.\n12. Life expectancy ≥6 months.\n\nExclusion Criteria:\n\n1. Synchronous colorectal cancer liver metastases.\n2. Active hepatitis, cirrhosis, or Child-Pugh class C.\n3. Extralepatic metastases to: central nervous system \u002F bone marrow \u002F brain (UICC 8th edition).\n4. Liver metastases not measurable.\n5. Prior history of oncolytic virus therapy (e.g., T-VEC).\n6. Liver metastases not meeting the requirements for peritumoral injection volume or unsuitable for peritumoral injection.\n7. History of severe drug allergy (e.g., to oncolytic adenovirus, PD-1 monoclonal antibody, platinum agents, 5-FU, leucovorin, 5-HT3 receptor antagonists, bevacizumab, etc.).\n8. Antiviral therapy (e.g., acyclovir, ganciclovir, valacyclovir, vidarabine) within 4 weeks prior to the first dose of study treatment.\n9. Participation in another clinical trial within 4 weeks or ongoing participation.\n10. History of prior therapy targeting PD-1, PD-L1, PD-L2, CTLA-4, or any other T-cell co-stimulation or checkpoint pathway.\n11. Severe electrolyte abnormalities.\n12. Significant portal hypertension: history of upper gastrointestinal bleeding or severe hypersplenism.\n13. Arterial or deep venous thrombosis within the past 6 months; history or evidence of bleeding tendency within the past 2 months.\n14. Pregnant or breastfeeding women, or women with a positive pregnancy test before the first dose; or female participants and their partners unwilling to use strict contraception during the study.\n15. Active autoimmune disease requiring systemic treatment (e.g., immunomodulators, corticosteroids, immunosuppressants) within the past 2 years.\n16. Past or current other active malignancies (except malignancies cured \\>3 years ago or carcinoma in situ treated curatively).\n17. Severe ECG abnormalities; active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina, or myocardial infarction within 12 months; New York Heart Association (NYHA) class II or higher congestive heart failure.\n18. Active infection (with fever \\>38°C).\n19. Poorly controlled hypercalcemia, hypertension, or diabetes.\n20. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).\n21. Psychiatric disorder affecting clinical treatment or history of central nervous system disease.\n22. Severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.).\n23. Persistent toxicity ≥ Grade 2 (CTCAE v5.0) from prior therapy (except anemia, alopecia, skin pigmentation).\n24. Use of any other investigational drug or participation in another interventional trial within 14 days prior to study treatment.\n25. Pregnant, breastfeeding, or planning pregnancy during the study; men or women unwilling to use effective contraception.\n26. Any unstable medical condition that may affect patient safety or compliance, as judged by the investigator to be unsuitable for the trial.","75 Years",{"count":333,"type":20},114,[24],"This prospective study aims to investigate the efficacy and safety of peritumoral injection of the oncolytic virus H101 in combination with stereotactic body radiotherapy (SBRT), PD-1 monoclonal antibody, chemotherapy, and targeted therapy for the treatment of patients with unresectable, microsatellite stable\u002Fmismatch repair proficient (MSS\u002FpMMR) colorectal adenocarcinoma liver metastases. The ultimate goal is to provide high-level evidence-based medical support for this combined modality approach.",[32,337],"Liver Metastasis Colon Cancer",[339,340,341,342],"Stereotactic body radiation therapy","Targeting Therapy","PD-1 Monoclonal Antibody","Oncolytic Virus","2026-04-22",{"date":345,"type":45},"2026-04-28",{"date":247,"type":20},{"date":348,"type":20},"2029-02-01",{"name":350,"class":79},"Jun Huang",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":21,"phases":360,"briefSummary":361,"conditions":362,"keywords":365,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":380},"100550283","phase-1-study-of-rason-inhibitors-in-patients-with-gastrointestinal-solid-tumors-100550283","NCT06445062","Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors","Inclusion Criteria:\n\nAll Patients (unless otherwise noted):\n\n* ≥ 18 years of age\n* ECOG PS is 0 to 1\n* Adequate organ function as outlined by the study\n* Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C)\n* Presence of RAS G12D mutation (Subprotocol D, E, F)\n\nExclusion Criteria:\n\nAll Patients:\n\n* Primary central nervous system (CNS) tumors\n* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs\n* Major surgery within 28 days of first dose\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":359,"type":20},1130,[23,24],"The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.\n\nThe current subprotocols include the following:\n\nSubprotocol A: RMC-6236 + 5-fluorouracil-based regimens\n\nSubprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6\n\nSubprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel\n\nSubprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens\n\nSubprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6\n\nSubprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel",[35,32,244,241,363,364],"Gastrointestinal Cancer","Metastatic Pancreatic Ductal Adenocarcinoma",[32,241,40,366,35,208,367,368,369,370,371],"KRAS G12X","Pancreatic Ductal Carcinoma","KRAS Q61 Mutation","KRAS G12 Mutation","RAS Wild-type","RAS G12D Mutation","2026-03-26",{"date":374,"type":45},"2026-04-01",{"date":376,"type":45},"2024-05-24",{"date":378,"type":20},"2027-07-15",{"name":51,"class":52},32,{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":195},"100608670","phase-1-the-phase-1biia-open-label-dose-escalation-and-dose-expansion-to-evaluate-safety-tolerability-and-preliminary-efficacy-of-the-combination-of-hcb101-cetuximabbevacizumab-and-folfoxfolfiri-in-advanced-or-metastatic-colorectal-cancer-100608670","NCT07204574","The Phase 1b\u002FIIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuximab\u002FBevacizumab, and FOLFOX\u002FFOLFIRI in Advanced or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Subjects are able to understand and willing to provide signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, including study visits and study-related procedures.\n2. Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent.\n3. With histologically\u002Fcytologically confirmed diagnosis of unresectable locally advanced or metastatic colorectal cancer, with both RAS and BRAF wild-type, who have experienced treatment failure with prior chemotherapy for locally advanced or metastatic disease (intended for second-line treatment). Previous chemotherapy may have included 5-FU, oxaliplatin, or irinotecan.\n4. Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n5. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at Screening.\n6. Able to provide archived or fresh tumor tissue samples for CD47 expression, immune score, and whole-exome sequencing (WES) analysis, if applicable.\n7. Have a life expectancy of ≥12 weeks (according to the Investigator's judgment).\n8. Have adequate organ function, as indicated by the following laboratory parameters in below (had not received a blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 14 days prior to the administration of the first dose of study intervention).\n\n   \\-- a) Absolute neutrophil count ≥1.5 × 109\u002FL\n\n   \\-- b) Platelets ≥75 × 109\u002FL\n\n   \\-- c) Hemoglobin ≥9.5 g\u002FdL\n   * d) Total bilirubin ≤1.5 × upper limit of normal (ULN), \\\u003C3.0 × ULN if known Gilbert's disease\n   * e) Alanine aminotransferase and aspartate aminotransferase ≤3× ULN and ≤5× ULN for subject with liver metastasis\n   * f) Creatinine clearance ≥30 mL\u002Fmin (using Cockcroft Gault equation)\n   * g) Coagulation: International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5× ULN (The INR applies only to subjects who do not receive therapeutic anticoagulation).\n9. A) Female subjects should meet at least 1 of the following criteria before they can participate in the study:\n\n   1. Females who have no childbearing potential (i.e., physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.\n   2. Postmenopausal (total cessation of menses for ≥ 1 year).\n   3. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during the Screening Period (within 7 days prior to the first dose of the study intervention), must not be lactating, and must be willing to practice a highly effective contraceptive method throughout the study (i.e., from study entry up to 6 months after the last dose of the study intervention). A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year when used consistently and correctly. For the definition of WOCBP and highly effective methods of contraception.\n\nB) Male subjects are eligible to participate in the study if they have undergone a vasectomy or agree to use a highly effective method of contraception and refrain from donating sperm from study entry up to 6 months after the last dose of the study intervention.\n\nExclusion Criteria:\n\nSubjects are excluded from the study if any of the following criteria apply:\n\n-Medical Conditions\n\n1. With a known history of hypersensitivity to any components of the study intervention.\n2. With other malignancies requiring treatment within 2 years prior to the first dose will be excluded, except for locally curable basal cell or squamous cell skin cancer treated with curative intent, and other malignancies with no recurrence within 2 years.\n3. Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they are clinically stable for at least 28 days and have no evidence of new or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days prior to dosing with study intervention. Subjects on low-dose corticosteroids (\\\u003C20 mg prednisone or equivalent per day) may participate.\n4. Clinically significant cardiovascular condition, including:\n\n   • History of congestive heart failure (New York Heart Association Class \\>2);\n   * History of unstable angina within 6 months prior to the first dose of study intervention;\n   * New-onset angina or myocardial infarction within 6 months prior to the first dose of study intervention;\n   * New-onset of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within 6 months prior to the first dose of study intervention and still in unstable condition and requiring treatment or intervention. History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia will be allowed, provided the condition is stably controlled.\n5. History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QT interval corrected for heart rate using Fridericia's correction \\[QTcF\\] \\>470 msec at Screening, pacemaker installation, or previous diagnosis of congenital long QT syndrome).\n6. Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia (Note: subjects with chronic Grade 2 toxicities which are well managed and stable may be eligible per the discretion of the Investigator after discussion with the Sponsor and medical monitor, e.g., Grade 2 chemotherapy-induced neuropathy.)\n\n6\\. With known inherited or acquired bleeding disorders or bleeding diathesis. 7. Known congenital or acquired bleeding disorders or bleeding tendency. 8. Have RBC transfusion dependence defined as requiring more than 2 units of RBC transfusions during the 4-week period prior to Screening.\n\n9\\. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.\n\nPrior\u002FConcomitant Therapy\u002FTreatment 10. Subjects who have undergone major surgery, or have undergone radical radiotherapy within 28 days prior to the first dose of study intervention.\n\n11\\. Subjects who have undergone palliative radiotherapy within 14 days prior to the first dose of study intervention,=.\n\n12\\. Subjects who have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to the first dose of the study intervention.\n\n13\\. Any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy, and herbal\u002Falternative therapies with anti-cancer indications or targeted therapy) administered within 14 days or 5 half lives, whichever is longer, prior to the first dose of the study intervention.\n\n14\\. Have used herbal medication within 14 days prior to the first dose of the study intervention.\n\n15\\. Active use of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on a case-by-case basis. There will be no restriction for daily aspirin ≤ 100 mg\u002FQD.\n\n16\\. Have received any treatment targeting the CD47 or SIRPα pathway. 17. Received or planning to receive live virus or bacterial vaccine within 28 days prior to the first dose of study intervention while the subject receives the study intervention. Subjects who require Corona Virus Disease 2019 (COVID-19) vaccination while on study intervention must receive a non-live vaccine (e.g., one based on messenger RNA \\[mRNA\\] or fully inactivated\u002Fgenetically modified viruses incapable of replication).\n\nPrior\u002FConcurrent Clinical Study Experience 18. Participation in another clinical study with an investigational product administered in the last 14 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study intervention. Or An investigational device was used within 28 days prior to the first dose of study intervention.\n\nInfections 19. An uncontrolled acute infection, an active infection requiring systemic treatment, or subjects who have received systemic antibiotics within 14 days prior to the first dose of the study intervention (Note: prophylaxis use of systemic antibiotics treatment for upper tract infection is allowed as long as there is no violation of the requirement of concomitant medications).\n\n20\\. Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome or positive HIV testing having CD4+ T-cell counts \\\u003C350 cells\u002FµL or subjects with unknown HIV infection status who are unwilling to undergo HIV testing.\n\n21\\. Known active hepatitis B or C. Subjects with hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive test results during Screening must be further tested for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) titer (excluding subjects with a DNA titer of more than 2500 copies \\[cps\\]\u002FmL or 500 IU\u002FmL) and HCV ribonucleic acid (RNA) (excluding subjects with an HCV RNA concentration exceeding the lower detection limit of the assay) to exclude active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus carriers, i.e., subjects with stable hepatitis B infection after drug treatment (DNA titer not exceeding 2500 cps\u002FmL or 500 IU\u002FmL) and hepatitis C infected subjects who received treatment and achieved sustained virologic response for at least 12 weeks can be enrolled. Note: If the lower detection limit of the HBV DNA assay is higher than 2500 cps\u002FmL or 500 IU\u002FmL, the subjects with an HBV DNA assay result lower than the lower detection limit of the assay can be enrolled.\n\n22\\. Active tuberculosis. 23. Known to have a history of alcoholism or drug abuse. 24. Any other medical (e.g., Child-Pugh class B or C, pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.",{"count":388,"type":20},40,[23,24],"This is a non-randomized, open-label, dose-escalation and dose-expansion phase I\u002FII clinical study to evaluate the safety, tolerability, and efficacy of HCB101 in combination with Cetuximab\u002FBevacizumab, and FOLFOX\u002FFOLFIRI in Advanced or Metastatic Colorectal Cancer. The trial consists of two phases: the dose-escalation phase (I) and the dose-expansion phase (II).\n\nSubjects will receive a weekly single dose of HCB101 IV infusion over 60 (±10) minutes on Days 1, 8, and 15 in each 21-day cycle in combination with Bevacizumab (5 mg\u002Fkg IV day 1; given every 14 days) \u002FCetuximab (500 mg\u002Fm2 IV day 1; given every 14 days) , and FOLFIRI\u002FFOLFOX until unacceptable AE(s), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study whichever occurs first.",[32],"2025-09-24",{"date":394,"type":45},"2025-10-02",{"date":396,"type":45},"2025-05-14",{"date":398,"type":20},"2025-12-31",{"name":400,"class":79},"Chang Gung Memorial Hospital",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":21,"phases":411,"briefSummary":412,"conditions":413,"keywords":422,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":440},"100568558","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-a2b395-an-allogeneic-logic-gated-car-t-in-participants-with-solid-tumors-that-express-egfr-and-have-lost-hla-a02-expression-100568558","NCT06682793","A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","DENALI-1","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site).\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long-term safety follow-up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion\n5. Radiotherapy within 28 days of A2B395 infusion\n6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n8. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n9. Requires supplemental home oxygen\n10. Females of childbearing potential who are pregnant or breastfeeding\n11. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B395",{"count":410,"type":20},240,[23,24],"The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\n* Phase 1: What is the recommended dose of A2B395 that is safe for patients\n* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\n* Enrollment in BASECAMP-1 (NCT04981119)\n* Preconditioning lymphodepletion (PCLD) regimen\n* A2B395 Tmod CAR T cells at the assigned dose",[94,35,414,415,103,101,102,109,32,416,266,417,418,419,420,421,100],"Non-Small Cell Lung","NSCLC (Non-small Cell Lung Cancer)","Head and Neck Squamous Cell Cancer","Renal Cell Carcinoma","RCC","Kidney Cancer","Triple Negative Breast Cancer","TNBC",[112,113,423,115,424,118,425,32,426,121,122,427,103,30,428,109,429,418,419,430,431,421],"Allogeneic","EGFR","Solid tumors expressing EGFR","Colorectal","Blocker","Non small Cell Lung Cancer","renal cell carcinoma","Renal cell cancer","Triple negative breast cancer","2025-09-03",{"date":434,"type":45},"2025-09-09",{"date":436,"type":45},"2025-05-22",{"date":438,"type":20},"2030-03-31",{"name":135,"class":52},10,{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":21,"phases":451,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":80},"100536032","phase-1-a-study-of-spx-303-a-bispecific-antibody-targeting-lilrb2-and-pd-l1-in-patients-with-solid-tumors-100536032","NCT06259552","A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors","A Phase 1, Open-label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an Anti-LILRB2 \u002F PD-L1 Bispecific Antibody SPX- 303 in Patients With Solid Tumors","SPX-303","Inclusion Criteria:\n\n1. Males and females ≥18 years of age who comprehend, are not incarcerated, are willing and able to provide consent by signing an ICF, and able to comply with scheduled visits, treatment schedule, and laboratory tests, including other requirements for the study\n2. Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy\n3. Patients who have progressed on or after prior therapy and who are not eligible for available treatment options\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Has at least 1 measurable lesion per RECIST 1.1 criteria\n6. Recovery from previous treatment related adverse events (TRAEs) to allow safety evaluations of SPX-303. Previous TRAEs include adverse drug reactions, and consequences of radiation, surgery, and other therapeutic modalities\n7. Adequate hepatic function; bilirubin ≤1.5x upper limit of normal (ULN) (except for patients with Gilbert syndrome: ≤ 3xULN), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver metastases present).\n8. Adequate renal function as calculated (e.g. Cockroft Gault) creatine clearance (CrCl) ≥ 30 mL\u002Fmin or 24-hour urine CrCl ≥ 30 mL\u002Fmin.\n9. Adequate hematological function: absolute neutrophil count (ANC) ≥1 x 10\\^9\u002FL; platelets ≥75 x 10\\^9\u002FL, hemoglobin ≥9 g\u002FdL.\n10. Patients with well controlled HIV infection (ie CD4+ count \\>350 cells\u002FuL and viral copies less than 400\u002FmL after at least 4 weeks of ART) are eligible for the trial.\n11. Adequate coagulation function: INR, PT and aPPT ≤ 1.5x ULN except for patients on anti-coagulation as long as PT, aPPT, or INR are within intended range.\n12. Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 45% by multi-gated acquisition (MUGA) or echocardiography (ECHO) scan.\n13. Fridericia-corrected QT interval (QTcF) ≤480 msec.\n14. Women of childbearing potential must have a negative pregnancy test and must agree to use of 2 different methods of acceptable contraception from screening until 4 months after the last dose of study drug. Acceptable methods of contraception are defined as those that result, alone or in combination, in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, hormonal contraception in combination with a barrier method or abstinence).\n15. Males who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception (eg, condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) from screening until 4 months following the last dose of study drug, in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 4 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy \\>6 months before signing the ICF.\n\nExclusion Criteria:\n\n1. History of prior malignancy, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast, prostate) for which the patient has been disease free for at least 3 years. Prostate cancer patients on active surveillance are eligible.\n2. Active brain or leptomeningeal metastasis. Except patients with known brain metastases if they have been treated and MRI shows no evidence of progression for at least 8 weeks and require less than 10 mg\u002Fday prednisone\u002Fprednisolone or equivalent.\n3. Treatment with anti neoplastic therapy ≤ 28 days or ≤ 5× elimination half life, whichever is shorter, before the first dose of study drug.\n4. Major surgery requiring general anesthesia ≤ 28 days prior to dosing.\n5. History of permanent discontinuation of prior IO therapy due to irAE.\n6. Prior treatment targeting ILT2 and\u002For ILT4 or targeting HLA G.\n7. Live or live attenuated vaccine ≤ 28days prior to dosing.\n8. Immunosuppressive systemic medication, except topical corticosteroids or systemic corticosteroids at a dose level of ≤ 10 mg\u002Fd of prednisone\u002Fprednisolone or equivalent. Note: patients with adrenal insufficiency requiring hormonal replacement may receive higher dose of steroids.\n9. Prior solid organ or bone marrow transplantation (except cornea transplantation).\n10. History of clinically significant cardiovascular events (e.g. DVT ≤ 6 months, PE ≤ 12 months, MI or hospitalization for CHF ≤ 12 months, bleeding disorder or bleeding event ≤ 6 months, current clinically significant arrhythmia or unstable angina pectoris, current uncontrolled history of cerebrovascular accident in the past 6 months, current uncontrolled hypertension).",{"count":450,"type":20},232,[23],"Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 \u002F anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.",[154,266,418,32],[154],"2024-09-20",{"date":457,"type":45},"2024-09-24",{"date":459,"type":45},"2024-03-20",{"date":461,"type":20},"2027-09",{"name":463,"class":79},"SparX Biotech(Jiangsu) Co., Ltd.",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":331,"enrollmentInfo":471,"targetDuration":4,"studyType":21,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":195},"100561698","phase-2-lvosidenib-ak112-combined-with-capeox-and-radiotherapy-in-patients-with-unresectable-metastatic-mss-type-colorectal-cancer-100561698","NCT06593548","Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer","A Prospective, Single-arm, Single-center, Phase II Clinical Study of Ivosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer: Efficacy and Safety Assessment","Inclusion Criteria:\n\n* Aged 18-75.\n* ECOG performance status of 0-1.\n* Initial diagnosis confirmed by colonoscopy and pathology as colorectal adenocarcinoma.\n* Imaging confirmation of multiple measurable metastases, deemed unresectable initially after MDT discussion.\n* No prior treatment or more than 1 year since completion of initial untreated\u002Fpost-operative adjuvant chemotherapy, and no previous anti-tumor therapy thereafter.\n* With good organ function, without contraindications for surgery or chemotherapy.\n* Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and international normalized ratio (INR) ≤ 1.5 × ULN (if not receiving anticoagulant therapy).\n* Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein quantitative test must show ≤ 1g protein.\n* Left ventricular ejection fraction (LVEF) ≥ 55%. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \\\u003C 470 msec.\n* Expected survival \\> 6 months.\n* Clear status of KRAS, NRAS, BRAF, and HER2 genes.\n* Microsatellite stable or mismatch repair protein proficient patients.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years or \\>75 years.\n* History of any other malignancy within 5 years, except adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma that has been effectively controlled.\n* Malignant pleural or peritoneal effusion.\n* Severe internal medical complications preventing chemotherapy or surgery.\n* Clinical or radiological evidence of spinal cord compression, or tumor within 3 mm of the spinal cord on MRI.\n* Imaging-confirmed brain, ovarian, or peritoneal metastases.\n* Patients deemed suitable for aggressive systemic treatment to achieve conversion after MDT discussion.\n* Pathologically diagnosed signet ring cell carcinoma.\n* Patients with microsatellite instability or mismatch repair protein deficiencies.\n* Patients with intestinal obstruction, perforation, bleeding requiring emergency surgical resection.\n* Immunodeficiency diseases, including primary immunodeficiency diseases (genetically determined) or secondary immunodeficiency diseases.\n* Known or suspected interstitial pneumonia.\n* Severe cardiovascular diseases, including but not limited to conditions meeting NYHA class (III or higher), myocardial infarction or cerebrovascular accident (ischemic stroke, symptomatic cerebral infarction) within the past 3 months prior to first dosing, unstable angina or unstable arrhythmias within the past 1 month prior to first dosing, congestive heart failure beyond the above criteria, symptomatic superior vena cava syndrome, etc.\n* Venous thromboembolic events within the past 3 months, such as deep vein thrombosis and pulmonary embolism.\n* History of receiving live attenuated vaccines within 28 days prior to first study drug administration or anticipated need for live attenuated vaccines during the study period.\n* Active hepatitis B (defined as positive hepatitis B surface antigen \\[HBsAg\\] with HBV-DNA ≥500 IU\u002Fml).\n* Hepatitis C (defined as positive hepatitis C virus antibody \\[HCV-Ab\\]).\n* History of tuberculosis infection or treatment within the past 1 year prior to signing informed consent.\n* History of or planned allogeneic bone marrow or solid organ transplantation.\n* Abnormal coagulation function (INR \\> 1.5 or APTT \\> 1.5 × ULN), with bleeding tendency or undergoing thrombolysis or requiring long-term anticoagulant therapy with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday).\n* Peripheral neuropathy of Grade ≥2 according to NCI-CTCAE v5.0.\n* Concurrent other infectious diseases unsuitable for participation in this study.",{"count":472,"type":20},36,[24],"This is a prospective, single-arm, single-center Phase II clinical study. In this study, participants will receive Ivosidenib in combination with CapeOX chemotherapy and radiotherapy. The treatment regimen is as follows: participants will first receive Ivosidenib in combination with CapeOX chemotherapy during the first cycle, followed by radiotherapy starting 2 weeks after medication. Depending on the dose limits of normal tissue radiation, Stereotactic Ablative Radiotherapy (SABR), large fraction radiotherapy, or high-dose combined with low-dose radiotherapy will be administered to primary and metastatic lesions. One week after completing radiotherapy, participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment. If extensive primary and metastatic lesions cannot be treated with radiotherapy initially, participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment until the lesions shrink, at which point radiotherapy may be considered.\n\nAssessments will be conducted every 2 treatment cycles after treatment initiation, with multidisciplinary team (MDT) discussions to determine if No Evidence of Disease (NED) is achieved. Patients achieving NED may undergo surgery or local treatment, while those with stable or partial responses will continue combination therapy. Patients with disease progression will discontinue study treatment. Patients ineligible for surgical treatment will continue combination therapy until disease progression or until they exit the study for surgical treatment.\n\nDuring the study period, participants will undergo safety monitoring. The safety follow-up period is defined as 90 days after the last dose of Ivosidenib. Safety data will be collected from the time of informed consent signing until the end of the safety follow-up period or initiation of new anti-tumor treatment (whichever occurs first).",[32,476,477],"MSS","Metastatic Cancer","2024-09-10",{"date":480,"type":45},"2024-09-19",{"date":482,"type":20},"2024-11-01",{"date":484,"type":20},"2026-11-01",{"name":486,"class":79},"Fudan University",{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":331,"enrollmentInfo":494,"targetDuration":4,"studyType":21,"phases":496,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":508},"100551066","phase-2-cadonilimab-combined-with-regorafenib-as-a-third-line-treatment-in-patients-with-mss-crlm-100551066","NCT06455254","Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM","A Single-arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Candonilimab（AK104） Combined With Regorafenib For the Third-line Treatment of MSS Colorectal Liver Metastasis","Inclusion Criteria:\n\n* Age \\> 18 years old and \\\u003C 75 years old;\n* ECOG Performance status score 0 or 1;\n* Histologically or cytologically confirmed adenocarcinoma of colon or rectum, with liver metastases, with or without extrahepatic metastases;\n* At least one measurable lesion as defined by RECIST version 1.1;\n* Progressed or be intolerant to prior systemic therapy including fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab and\u002For cetuximab\u002Fpanitumumab (if RAS\u002FRAF-wild-type);\n* Known RAS and BRAF status;\n* Only patients with mismatch repair-proficient (pMMR)\u002Fmicrosatellite stable (MSS) status;\n* Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:\n\nLiver and renal function: Total bilirubin ≤ 1.5× ULNl; aspartate transaminase (AST), alanine transaminase (ALT) ≤ 5× ULN; Serum creatinine ≤ 1.5× ULN; Bone-marrow function: Neutrophil count ≥ 1.5×10\\^9\u002FL, Hemoglobin (Hb) ≥ 9.0 g\u002FdL, Platelet count ≥ 100×10\\^9\u002FL; International normalised ratio (INR) and partial thromboplastin time (PTT) ≤1.5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care；\n\n* Patients of childbearing potential must be willing to use highly effective contraception for the duration of the study and for ≥120 days after the last dose of cadonilimab; female patients with a negative urine or serum pregnancy test result within ≤3 days prior to the first dose of the drug;\n* Able to understand and voluntarily sign written informed consent;\n* No history of allergy to regorafenib, cadonilimab and its components.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding;\n* Patients who have previously been treated with third-line regimens such as regorafenib, fruquintinib, trifluridine tipiracil, or other immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or any cellular immunotherapy;\n* Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants), replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;\n* Active or prior history of definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);\n* Patients who have received intervention, ablation or radiotherapy within the previous 3 months for the target lesion;\n* Patients with an expected survival time of less than 3 months;\n* Study participants with other malignant tumors within 3 years prior to enrollment, excluding cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.);\n* Patients with severe psychological or psychiatric abnormalities;\n* No history of severe arrhythmia, heart failure, severe ventilatory dysfunction and severe lung infection, no acute and chronic renal failure;\n* Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study;\n* Any other clinically significant disease or condition that, in the opinion of the investigator, may affect adherence to the protocol, or the signing of the Informed Consent Form (ICF) by the subject, or make participation in this clinical trial inappropriate.",{"count":495,"type":20},44,[24],"This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.",[32],"2024-07-27",{"date":501,"type":45},"2024-07-30",{"date":503,"type":45},"2024-07-11",{"date":505,"type":20},"2026-06",{"name":507,"class":79},"Jin-hong Chen",3,{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":179,"enrollmentInfo":516,"targetDuration":4,"studyType":21,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":195},"100531121","phase-1-clinical-study-of-short-course-radiotherapy-followed-by-fruquintinib-plus-sintilimab-vs-bevacizumab-plus-capecitabine-as-first-line-treatment-in-advanced-mcrc-100531121","NCT06195670","Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC","An Open-label, Multi-centered, Two-stage Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine in the First Line Treatment of Advanced mCRC Patients Unfit for Intense Therapy","Inclusion Criteria:\n\n* Have signed an informed consent;\n* 18 to 85 years old (including 18 and 85 years old);\n* Histopathologically confirmed unresectable advanced metastatic colorectal adenocarcinoma;\n* Have not received anti-tumor treatment for metastatic disease;\n* Inability to tolerate intensive treatment regimens based on oxaliplatin or irinotecan as determined by researchers;\n* At least one measurable lesion;\n* Expected life expectancy ≥ 12 weeks;\n* The function of important organs within the 14 days prior to enrollment meets the following requirements (no blood components or cell growth factors are allowed to be used within the 14 days prior to enrollment):\n* Neutrophil absolute count ≥ 1.5 × 10\\^9\u002FL;\n* Platelets ≥ 80 × 10\\^9\u002FL;\n* Hemoglobin ≥ 8g\u002FdL;\n* Total bilirubin\\\u003C1.5 times ULN;\n* ALT and AST\\\u003C2.5 times ULN (liver metastasis patients\\\u003C5 times ULN);\n* Serum creatinine ≤ 1.5 times ULN;\n* Endogenous creatinine clearance rate\\>50ml\u002Fmin;\n* International standardized ratio (INR) of coagulation function ≤ 1.5 × ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n* Women of childbearing age or men whose partners have a desire to conceive should take effective contraceptive measures.\n\nExclusion Criteria:\n\n* Currently has a disease or condition that affects drug absorption, or the patient is unable to take oral drugs;\n* Currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;\n* History of serious cardiovascular and cerebrovascular diseases;\n* Other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;\n* Clinically uncontrolled active infection, such as acute pneumonia, active hepatitis B or hepatitis C (hepatitis B virus DNA ≥ 1 × 104 copies\u002FmL or\\>2000 IU\u002Fml);\n* Currently has central nervous system (CNS) metastasis or has a history of unstable or clinically symptomatic brain metastasis;\n* Pregnant (positive pregnancy test before medication) or breastfeeding women;\n* Urine protein ≥ 2+, or 24-hour urine protein \\>1.0g;\n* Histologically confirmed MSI-H\u002FdMMR tumors;\n* Patients deemed unsuitable by the researchers for inclusion in this study.",{"count":517,"type":20},220,[23,24],"The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.",[32,521,522],"Metastatic Colorectal Cancer","Metastatic Colorectal Adenocarcinoma","2023-12-22",{"date":525,"type":45},"2024-01-08",{"date":527,"type":20},"2024-01",{"date":529,"type":20},"2027-01",{"name":531,"class":79},"Zhejiang Cancer Hospital",{"id":533,"slug":534,"hasResults":11,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":331,"enrollmentInfo":539,"targetDuration":4,"studyType":21,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":4},"100457672","phase-2-phase-ii-clinical-study-to-evaluate-the-efficacy-and-safety-of-hlx07hlx10-mfolfox6-or-hlx07-monotherapy-in-patients-with-mcrc-100457672","NCT05239650","Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC","An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Age\\>=18Y and ≤75Y\n* Good Organ Function\n* Expected survival time ≥ 3 months\n* mCRC that have been diagnosed histologically\n* KRAS\u002FNRAS\u002FBRAF WT verified by PCR or NGS of tumor tissue\n* ECOG score 0-1;\n\nExclusion Criteria:\n\n* HIV infection\n* Active clinical severe infection;\n* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.",{"count":540,"type":20},50,[24],"This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.",[32],"2022-05-01",{"date":546,"type":45},"2022-05-03",{"date":548,"type":20},"2022-07-15",{"date":550,"type":20},"2026-10-15",{"name":552,"class":52},"Shanghai Henlius Biotech"]