[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-colorectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,52,82,107,138,162,189,216,237,257,285,305,327,360,391,414,437,458,484,522,552,572,599,646,668],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100146180","phase-2-immunotherapy-using-tumor-infiltrating-lymphocytes-for-patients-with-metastatic-cancer-100146180",false,"NCT01174121","Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer","A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab","* INCLUSION CRITERIA:\n* Measurable (per RECIST v1.0 criteria), metastatic cancer of one of the following types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian\u002Fendometrial, or endocrine tumors including neuroendocrine tumors. Patients must have at least one lesion that is resectable for TIL generation with minimal morbidity, preferentially using minimal invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor deposit.\n* Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology.\n* Refractory to approved standard systemic therapy. Specifically:\n\n  * Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan.\n  * Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent.\n  * Patients with breast and ovarian cancer must be refractory to both first- and second-line treatments and must have received at least one second-line chemotherapy regimen.\n* Patients with 3 or fewer brain metastases that are \\\u003C 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1.\n* Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and for four months after treatment for individuals that can father children.\n* IOCBP must have a negative pregnancy test be a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nSerology\n\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\nHematology\n\n* ANC \\> 1000\u002Fmm\\^3 without the support of filgrastim\n* WBC greater than or equal to 2500\u002Fmm\\^3\n* Platelet count greater than or equal to 80,000\u002Fmm\\^3\n* Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n\nChemistry\n\n* Serum ALT\u002FAST less than or equal to 5.0 x ULN\n* Serum creatinine less than or equal to 1.5 x ULN\n* Total bilirubin less than or equal to 2.0 mg\u002FdL, except in patients with Gilbert s Syndrome, who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n* Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to less than or equal to grade 1.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n* Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* Grade 3 or 4 major organ irAEs clinically attributed to anti-PD-1\u002FPD-L1 therapy.\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immunecompetence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* History of coronary revascularization or ischemic symptoms.\n* For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction.\n* For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.\n* Patients who are receiving any other investigational agents.","ALL","18 Years","72 Years",{"count":21,"type":22},332,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\nThe NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian\u002Fendometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells.\n\nObjective:\n\nThe purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian\u002Fendometrial tumors to shrink and to see if this treatment is safe.\n\nEligibility:\n\n\\- Adults age 18-72 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian\u002Fendometrial cancer, or glioblastoma refractory to standard chemotherapy.\n\nDesign:\n\nWork up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed.\n\nSurgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product.\n\nLeukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. (Leukapheresis is a common procedure, which removes only the white blood cells from the patient.)\n\nTreatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.\n\nFollow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.",[28,29,30,31,32],"Metastatic Colorectal Cancer","Metastatic Pancreatic Cancer","Metastatic Ovarian Cancer","Metastatic Breast Carcinoma","Metastatic Endocrine Tumors\u002F Neuroendocrine Tumors",[34,35,36,37,38],"Digestive Tract Cancers","Breast Cancer","Endocrine Tumors","Ovarian\u002FEndometrial Cancer","Genitourinary Cancer","RECRUITING","2026-08-21",{"date":42,"type":43},"2026-08-24","ACTUAL",{"date":45,"type":43},"2010-08-26",{"date":47,"type":22},"2029-12-27",{"name":49,"class":50},"National Cancer Institute (NCI)","NIH",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100535501","phase-3-study-of-sotorasib-panitumumab-and-folfiri-versus-folfiri-with-or-without-bevacizumab-awwb-in-treatment-nave-participants-with-metastatic-colorectal-cancer-with-kras-pg12c-mutation-100535501","NCT06252649","Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","CodeBreaK 301","Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan",{"count":61,"type":22},450,[63],"PHASE3","The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.",[28],[67,68,69,70,71],"Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology","2026-08-20",{"date":40,"type":43},{"date":75,"type":43},"2024-07-17",{"date":77,"type":22},"2032-04-25",{"name":79,"class":80},"Amgen","INDUSTRY",291,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100579143","phase-2-a-study-to-evaluate-the-adverse-events-and-efficacy-of-intravenous-iv-of-telisotuzumab-adizutecan-in-combination-with-iv-oxaliplatin-fluorouracil-folinic-acidleucovorin-bevacizumab-panitumumab-in-adult-participants-with-metastatic-colorectal-cancer-100579143","NCT06820463","A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid\u002FLeucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the criteria within the protocol.\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and\u002For any topoisomerase inhibitor(s) (e.g., irinotecan).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.",{"count":91,"type":22},390,[25],"CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU\u002FLV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab\u002Fpantitumumab. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[28],[28,96,97],"AndroMETa-CRC-533","Telisotuzumab Adizutecan","2026-08-19",{"date":40,"type":43},{"date":101,"type":43},"2025-04-24",{"date":103,"type":22},"2028-04",{"name":105,"class":80},"AbbVie",64,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100577007","phase-2-a-study-of-novel-study-interventions-and-combinations-in-participants-with-colorectal-cancer-100577007","NCT06792695","A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer","A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)","CANTOR","Overall Inclusion Criteria:\n\n* Histopathologically confirmed colorectal adenocarcinoma.\n* Provision of FFPE tumor sample collected as per SoC.\n* Presence of measurable disease by RECIST 1.1 criteria.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks at the time of screening.\n\nSubstudy Inclusion Criteria:\n\n* No radiological evidence of liver metastasis.\n* No prior systemic therapy for mCRC, except for neoadjuvant\u002Fadjuvant chemotherapy where, \\> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease.\n* Known pMMR\u002FMSS status (only pMMR\u002FMSS mCRC allowed).\n* Adequate organ and bone marrow function\n* Body weight \\> 35 kg at screening and at randomization.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nOverall Exclusion Criteria:\n\n* Central nervous system metastases or spinal cord compression\n* Known history of severe allergy to any monoclonal antibody or study intervention.\n* Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.\n* History of another primary malignancy.\n\nSubstudy Exclusion Criteria:\n\n* Potentially resectable disease with multidisciplinary plan for radical surgery.\n* Active or prior documented autoimmune or inflammatory disorders or cardiac conditions.\n* Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks.\n* Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident.\n* History of abdominal or tracheoesophageal fistula, GI perforation and\u002For fistulae, or intraabdominal abscess within 6 months prior to randomization.\n* Prior exposure to immune mediated therapy.","130 Years",{"count":117,"type":22},80,[25],"The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).",[28],[122,123,124,125,126,127,113],"Metastatic disease","Immunotherapy","Liver metastasis","Mismatch-repair-proficient","Antibody targeting","Colorectal Cancer","2026-08-17",{"date":130,"type":43},"2026-08-18",{"date":132,"type":43},"2025-03-12",{"date":134,"type":22},"2028-09-29",{"name":136,"class":80},"AstraZeneca",76,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":51},"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":146,"type":22},84,[148],"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",[127,151,28],"Metastatic Colon Cancer",[127,151,28,153],"Early Stage Colorectal Cancer",{"date":98,"type":43},{"date":156,"type":43},"2024-07-22",{"date":158,"type":22},"2028-07-31",{"name":160,"class":161},"Dana-Farber Cancer Institute","OTHER",{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":51},"100527570","phase-1-phase-iii-study-of-the-combination-immunotherapy-regimen-sx-682-triadeno-vaccine-retifanlimab-and-il-15-agonist-n-803-star15-for-metastatic-colorectal-cancer-mcrc-100527570","NCT06149481","Phase I\u002FII Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)","* INCLUSION CRITERIA:\n* Participants with histologically confirmed colorectal cancer and evidence of metastatic disease.\n* Participants must have received, been ineligible to receive, or refused to receive two lines of standard systemic therapy i.e., a fluoropyrimidine with oxaliplatin or irinotecan with bevacizumab, regorafenib, trifluridine, and (if history of RAS wild-type) EGFR-targeted therapy. Participants must have received one line of systemic checkpoint inhibitor if history of advanced microsatellite instability-high \\[MSI-H\u002FdMMR\\]) metastatic colon cancer.\n* Participants who had progressive disease within 6 months before study treatment following standard adjuvant therapy are eligible if they have not received systemic therapy for metastatic disease. Participants with a history of MSI-H\u002FdMMR must have also received one line of checkpoint inhibitor therapy.\n* Age \\>= 18 years.\n* Measurable disease per RECIST 1.1.\n* ECOG performance status \\\u003C= 2.\n* Adequate organ and marrow as a function defined below:\n\n  * absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3\n  * platelet count \\>= 100,000 cells\u002Fmm\\^3\n  * hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * total bilirubin level \\\u003C 1.5 x upper limit of normal (ULN)\n  * alanine aminotransferase (ALT) \\\u003C= 2.5 x ULN OR \\\u003C= 5 x ULN for participants with liver metastases\n  * aspartate aminotransferase (AST) level \\\u003C= 2.5 x ULN OR \\\u003C= 5 x ULN for participants with liver metastases\n  * creatinine clearance (CrCl) calculated by Cockroft-Gault formula \\>= 50 mL\u002Fmin\n* Resolution of toxic effect(s) of prior anti-cancer therapy (except alopecia and neuropathy) to Grade \\\u003C=1 or to \\\u003C=2 if effective medical management of those toxicities is in place such that they are controlled per standard of care (e.g., grade 2 hypothyroidism requiring oral thyroid replacement).\n* Participants with treated brain metastases are eligible if clinically appropriate follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Participants positive for human immunodeficiency virus (HIV) are eligible if they are compliant with appropriate anti-retroviral therapy for at least 6 months, have HIV viral load \\\u003C400 copies\u002FmL, and a CD4 count \\> 350 cells\u002Fmicroliter at screening.\n* Participants positive for Hepatitis C virus (HCV) are eligible if they have completed definitive anti-viral therapy and have an undetectable viral load.\n* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization) at study entry and up to 6 months after the last dose of the study drug(s).\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after study treatment discontinuation.\n* Participants must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies in the phase 1 portion of the study. Lesions to be biopsied will be determined safely accessible by the provider performing the biopsy (e.g. interventional radiology if a liver or lung biopsy) prior to performing the biopsy. Note: If Phase 2 opens, per the investigator s discretion, if biopsy is strenuous to obtain, e.g., no easily accessible lesions are available or the subject\n\ncondition is not amenable for biopsy, then the subject will be eligible for enrollment without biopsy at screening and for continuation of treatment without on-treatment study biopsy.\n\n-Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation.\n* Participants with palliative radiotherapy performed within 7 days prior to study treatment initiation.\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent) with the exception of:\n\n  * intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections in participants with asthma\n  * using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption\n  * brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy).\n* Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. Participants with chronic post-radiation pulmonary changes\u002Fscarring that is asymptomatic are eligible.\n* Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 8 days prior to treatment initiation. Participants who have had appropriate antibiotics initiated but are still completing the treatment course are eligible if clinically improved or had minimal symptoms at presentation (e.g., urinary tract infection or pharyngeal streptococcal infection without evidence of systemic inflammatory response).\n\n  * History of organ transplant, including allogeneic stem cell transplantation.\n  * Participants who experienced immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring systemic corticosteroids (with the exception of endocrinopathy that is well controlled on replacement hormones).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n* Receipt of a live vaccine within 28 days prior to treatment initiation. Note: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n* History of infection with Hepatitis B virus (HBV) unless on suppressive therapy. Individuals with serologic evidence of a resolved prior HBV infection (i.e., HBsAgnegative and anti-HBc positive) are eligible.\n* Pregnancy confirmed with Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.","120 Years",{"count":170,"type":22},60,[172,25],"PHASE1","Background:\n\nEach year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs. This is called metastatic colorectal cancer (mCRC). Most people with mCRC survive only about 2 years.\n\nObjective:\n\nTo test the ability of a combination of up to 4 experimental anti-cancer drugs treat mCRC. The names of these drugs are retifanlimab, TriAdeno vaccine, N-803, and SX-682. They are described below.\n\nEligibility:\n\nAdults aged 18 years or older with mCRC. Participants must have\n\nDesign:\n\nParticipants will be screened. This includes having a physical exam, blood tests, urine tests, and imaging tests. If signed on to the study, participants will have 2 tumor biopsies. One when starting the study and once about 8 weeks after bring on the study. Participants will receive $500 for each biopsy.\n\nParticipants will be treated with either 3 or 4 drugs and will receive a detailed calendar explaining when each drug is given.\n\nRetifanlimab is given every 4 weeks through an IV (an IV is tube attached to a needle inserted into a vein in the arm). N-803 is injected under the skin on the abdomen every 4 weeks.\n\nTriAdeno vaccine is injected under the skin of the upper arm or thigh once a month for 3 doses and then once every 3 months.\n\nSome participants will also receive a 4th drug. SX-682 is a pill taken by mouth. Participants will take this drug 2 times a day at home for about 3 weeks of each month.\n\nStudy treatment will continue up to 2 years. Follow-up phone calls\u002Femails may continue for 3 more years.",[28],[176,177,178,179,180,181],"Monoclonal Antibody","Brachyury","MUC-1","Immunoglobulin G cytokine fusion protein","chemokine antagonist","Small Molecule","2026-08-14",{"date":128,"type":43},{"date":185,"type":43},"2024-03-26",{"date":187,"type":22},"2030-10-31",{"name":49,"class":50},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100635186","phase-3-a-study-of-precemtabart-tocentecan-with-or-without-bevacizumab-compared-to-trifluridinetipiracil-plus-bevacizumab-in-participants-with-previously-treated-metastatic-colorectal-cancer-proceade-crc-03-100635186","NCT07549412","A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine\u002FTipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine\u002FTipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","Inclusion Criteria:\n\n* Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.\n* Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting\n* Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1\n* Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations\n* Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0\n* Participant has a history of additional malignancy within 3 years before randomization\n* Participants with known brain metastases\n* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization\n* Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and\u002For bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments\n* Other protocol defined exclusion criteria may apply",{"count":197,"type":22},1020,[63],"This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride\u002Ftipiracil (FTD-TPI) plus bevacizumab.",[28],[202,203,204,205,206],"CEACAM5","Antibody-drug conjugate","Exatecan","M9140","Precem-TcT","2026-08-13",{"date":182,"type":43},{"date":210,"type":43},"2026-05-06",{"date":212,"type":22},"2029-10-16",{"name":214,"class":80},"EMD Serono Research & Development Institute, Inc.",34,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":146},"100433830","phase-1-a-study-evaluating-the-safety-and-efficacy-of-targeted-therapies-in-subpopulations-of-patients-with-metastatic-colorectal-cancer-intrinsic-100433830","NCT04929223","A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)","A Phase I\u002FIb Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)","Inclusion Criteria\n\n* Signed cohort-specific Informed Consent Form\n* Age \\>= 18 years at time of signing Informed Consent Form\n* Biomarker eligibility as determined by:\n\n  * A validated test approved by local health authorities for detection of the specified biomarkers\u002Fmutations.\n  * A validated test performed at a College of American Pathologists\u002Fclinical laboratory improvement amendments (CAP\u002FCLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.\n  * Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR\n  * Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C= 1\n* Life expectancy \\>= 3 months, as determined by the investigator\n* Histologically confirmed adenocarcinoma originating from the colon or rectum\n* Metastatic disease\n* Prior therapies for metastatic disease\n* Ability to comply with the study protocol, in the investigators judgment\n* Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures\n* For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm\n\nExclusion Criteria\n\n* Current participation or enrollment in another interventional clinical trial. Participants who are participating in the follow-up period of an interventional clinical trial are eligible for the study.\n* Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Pregnant or breastfeeding, or intending to become pregnant during the study\n* History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study\n* Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety\n* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Uncontrolled tumor-related pain\n* Uncontrolled or symptomatic hypercalcemia\n* Clinically significant and active liver disease\n* Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.\n* Symptomatic, untreated, or actively progressing CNS metastases\n* History of leptomeningeal disease or carcinomatous meningitis\n* History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death\n* Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications\n* Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher risk for treatment-related complications",{"count":224,"type":22},542,[172],"This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.",[28],[229],"KRAS G12C",{"date":128,"type":43},{"date":232,"type":43},"2021-10-22",{"date":234,"type":22},"2030-08-31",{"name":236,"class":80},"Hoffmann-La Roche",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":246,"phases":4,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":249,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":4},"100641121","a-study-of-fruquintinib-in-adults-with-metastatic-colorectal-cancer-in-poland-100641121","NCT07623174","A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland","FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients","Inclusion Criteria:\n\n1. Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride\u002Ftipiracil.\n2. Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.\n3. Participants for whom adequate medical records are available to support the data collection requirements.\n\nExclusion Criteria:\n\n1\\. Participant currently participates or plans to participate in an interventional clinical trial.",{"count":245,"type":22},110,"OBSERVATIONAL","Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life.\n\nThe main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth.\n\nOther aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study.\n\nThe study will look at data already existing in the participants' medical charts.",[28],"NOT_YET_RECRUITING","2026-08-12",{"date":182,"type":43},{"date":72,"type":22},{"date":254,"type":22},"2028-03-31",{"name":256,"class":80},"Takeda",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":51},"100614263","phase-1-neoadjuvant-dupilumab-and-toripalimab-in-mss-crc-subjects-with-resectable-liver-metastases-100614263","NCT07277322","Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases","Master Protocol for A Phase 1b\u002F2 Study of Neoadjuvant Immunotherapy in Microsatellite Stable (MSS) Colorectal Cancer (CRC) Subjects With Resectable Liver Metastases","INCLUSION CRITERIA:\n\nHistological diagnosis of non-MSI-H\u002FpMMR CRC\n\n• Subjects who have biology-proven non-MSI-H\u002FpMMR CRC and with radiographic findings suggestive of liver metastases may be eligible.\n\nResectable liver metastases including:\n\n* synchronous liver metastases (present at the time of diagnosis of MSS CRC) and treatment-naïve\n* metachronous liver metastasis (developed after resection of the primary tumor) without prior adjuvant chemotherapy\n* metachronous liver metastasis (developed after resection of the primary tumor) with adjuvant chemotherapy completed greater than 3 months from the time of consent.\n\nSurgical candidate for resection\n\nAge ≥ 18 years. Rationale: Because no dosing or adverse event data are currently available on the use of dupilumab in combination with toripalimab in subjects \\\u003C18 years of age, children are excluded from this study.\n\nECOG Performance Status 0-1 (Karnofsky ≥60%,)\n\n• Subjects with performance status \\>1 carrying long-term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy may be enrolled at the investigator's discretion\n\nWomen of child-bearing potential (WOCBP) and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy.\n\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\nAbility to understand and the willingness to sign a written informed consent. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nAdequate organ and marrow function as defined:\n\n* Hematologic\n\n  o Absolute neutrophil count (ANC) ≥1,000 \u002FmcL\n  * Platelets ≥75,000 \u002FmcL\n  * Hemoglobin ≥8 g\u002FdL\n* Renal\\* o Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated (Creatinine clearance should be calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥45 mL\u002Fmin for subjects with creatinine levels \\> 1.5 X institutional ULN\n* Hepatic\\* o Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN; ≤ 3 X ULN for subjects with liver metastases o AST ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n\n  * ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * Albumin \\>2.5 mg\u002FdL\n* Coagulation\\*\n\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants \\* If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the lab values will not be used to exclude subject from this trial. This determination will be made by PI.\n\nEXCLUSION CRITERIA:\n\nHistory of autoimmune disorder with the following exceptions:\n\n* Vitiligo, alopecia, psoriasis or any chronic skin condition that does not require systemic therapy\n* Hypothyroidism (e.g. following autoimmune thyroiditis) stable on thyroid replacement\n* Celiac disease controlled by diet alone\n\nTreatment, for any reason, with an immunomodulatory drug, within 8 weeks from time of consent.\n\nPrior treatment with dupilumab within the last 8 weeks.\n\nPrior treatment with chemotherapy for MSS CRC or locoregional therapy to the target lesion (that will be biopsied and subsequently resected) within 3 months prior to entering the study.\n\n• Previous therapy for a different cancer (a different primary) is acceptable.\n\nUse of investigational agents for treatment of cancer.\n\nSubjects with extrahepatic metastases that are not amendable to resectable or locoregional therapy, for whom the intent of surgery would not be curative.\n\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10 days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, as determined the treating investigator.\n\nPregnant or nursing women due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n\n• Breastfeeding should be discontinued prior to study enrollment.\n\nHas a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n\n• Chronic steroids equivalent to ≤ 10mg prednisone are permitted.\n\nHas active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n• Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.\n\nHas a known additional malignancy that is progressing and requires active treatment.\n\n• Exceptions include: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical or anal cancer, prostate cancer on stable dose of hormonal therapy without rising PSA, and breast cancer treated with curative intent now on hormonal therapy.\n\nHas a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n\nHIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \\\u003C200 CD4+ T cells\u002Fmicroliter in the peripheral blood. HIV testing is mandatory for patients with no known history of HIV. For such patients, HIV testing will be considered SOC.\n\nHas known active Hepatitis B (e.g., HBV detected by PCR (\\>200 IU\u002Fml) or known active Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n\n• Subjects who started antiviral therapy \\>\u002F=14days from baseline are permitted.\n\nHistory of allogeneic hematopoietic cell transplantation or solid organ transplantation.\n\nDocumented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps) Principle investigator believes that for one or multiple reasons the subject will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the subject.",{"count":265,"type":22},24,[172,25],"This Phase 1b\u002F2 trial will evaluate the safety and efficacy of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.",[28,269],"Liver Metastases",[271,272,273,274,275,276],"Colorectal cancer","Liver metastases","Neoadjuvant immunotherapy","Dupilumab","Toripalimab","microsatellite stable","2026-08-10",{"date":250,"type":43},{"date":280,"type":22},"2026-09-01",{"date":282,"type":22},"2030-12-31",{"name":284,"class":161},"Dan Feng",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100624970","a-study-to-investigate-cea-prit-20-in-participants-with-metastatic-colorectal-cancer-mcrc-100624970","NCT07416552","A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)","A Phase I, Open-Label, Escalation and Expansion Study to Evaluate Dosimetry, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CEA-Pre-Targeted 212Pb Therapy in Participants With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma originating from the colon or rectum\n* Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7)\n* Confirmed MSS and\u002For proficient mismatch repair (MMR) status\n* Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease\n* Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Life expectancy estimated by the Investigator to be \\>=12 weeks\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1\n* Adequate cardiovascular, hematological and renal function and laboratory parameters\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intending to become pregnant\n* Participants with active central nervous system (CNS) metastases\n* History of malignancy other than the one under investigation\n* Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure\n* Major surgery or significant traumatic injury \\\u003C4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment\n* Participants have a known confirmed positive test for HIV\n* Positive hepatitis B surface antigen (HBsAg) test, and\u002For positive total hepatitis B core Ab (HBcAb) test at screening.\n* Positive hepatitis C (HCV) Ab test result at screening\n* Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1\n* Prior treatment with a CEA-targeted agent or systemic radio therapy",{"count":293,"type":22},180,[172],"This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with metastatic microsatellite-stable (MSS) mCRC who are intolerant to or have progressed after having received available standard-of-care (SOC) therapies.",[28],"2026-08-06",{"date":277,"type":43},{"date":300,"type":22},"2026-09-08",{"date":302,"type":22},"2034-02-12",{"name":236,"class":80},2,{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":246,"phases":4,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":249,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":323,"leadSponsor":325,"locationsCount":4},"100651051","circulating-tumor-extracellular-vesicles-for-non-invasive-monitoring-of-metastatic-colorectal-cancer-100651051","NCT07754513","Circulating Tumor Extracellular Vesicles for Non-Invasive Monitoring of Metastatic Colorectal Cancer","Circulating Tumor Extracellular Vesicles As Novel Non-invasive Biomarkers to Monitor Metastatic Colorectal Cancer Transcriptomic and Proteomic Evolution","EVA26","Retrospective Cohort Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically confirmed diagnosis of colorectal adenocarcinoma;\n* Radiological evidence of metastatic or locally advanced unresectable disease;\n* First-line treatment for metastatic disease already completed or ongoing according to standard clinical practice;\n* Availability of stored biological samples collected at least at one of the protocol-defined time points (baseline, post-treatment, disease progression);\n* Informed consent acquisition will be performed in accordance with Article 110-bis of the Italian Privacy Code.\n\nRetrospective Cohort Exclusion Criteria:\n\n* Absence of suitable biological samples or samples unsuitable for molecular analyses;\n* Incomplete clinical data preventing the performance of the planned analyses;\n* Insufficient quality of stored biological samples for the assessment of EV-RNA and EV-PROT analyses.\n\nProspective Cohort Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histologically confirmed diagnosis of colorectal adenocarcinoma;\n* Radiological evidence of unresectable metastatic disease;\n* Patients not previously treated for metastatic disease (prior completed adjuvant\u002Fneoadjuvant therapy is allowed if completed ≥ 6 months before study enrollment);\n* Indication for first-line treatment with chemotherapy ± biological therapy according to standard clinical practice;\n* Ability to understand the study procedures and provide written informed consent.\n\nProspective Cohort Exclusion Criteria:\n\n* Previous systemic treatment for metastatic disease (except prior adjuvant\u002Fneoadjuvant therapy as specified above);\n* Ongoing pregnancy or breastfeeding;\n* Legal incapacity or limitation in the ability to provide informed consent.",{"count":314,"type":22},290,"Metastatic colorectal cancer (mCRC) remains a major clinical challenge due to heterogeneous treatment responses and the development of therapeutic resistance. Current tissue-based molecular profiling is limited by invasiveness and the inability to enable longitudinal monitoring. Extracellular vesicles (EVs) represent a promising source of non-invasive biomarkers, carrying stable RNA and proteins reflective of tumor biology. This study aims to identify and validate EV-derived transcriptomic and proteomic biomarkers to monitor disease evolution, predict treatment response, and support personalized management of patients with mCRC.",[28],[318,319],"Circulating extracellular vesicles (EVs)","Biomarker discovery","2026-08-04",{"date":277,"type":43},{"date":280,"type":22},{"date":324,"type":22},"2029-09-01",{"name":326,"class":161},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":344,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":359},"100473299","targeted-therapy-drug-monitoring-in-digestive-oncology-100473299","NCT05443087","TARGETed Therapy Drug MONITOring in DIGestive Oncology","Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future","TARGETMONITO","Inclusion Criteria:\n\n1. Patient aged 18 years or over\n2. Advanced digestive cancer (histologically confirmed or confirmed by imaging for HCC) for which a standard treatment (according to each drug SmPC and as per standard of care) planned with:\n\n   * Regorafenib for GIST, mCRC, and HCC,\n   * Everolimus for gepNET,\n   * Sunitinib for pNET or GIST,\n   * Cabozantinib for HCC,\n   * Encorafenib - cetuximab for mCRC\n3. Life expectancy of greater than 3 months - at the discretion of the investigator\n4. Measurable disease according to tumor evaluation criteria as per local practice (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)\n5. Patients must be affiliated to a Social Security System (or equivalent)\n6. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n\nExclusion Criteria:\n\n1. Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor hormone therapy or immunotherapy) than the one studied\n2. Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior therapy\u002Fprocedure excluding alopecia and peripheral neuropathy\n3. Prior treatment with the same MKI molecule(s) planned to be given in the cohort. If different MKI molecules (from the one(s) planned in the study) have been previously taken, a wash out period of 2 weeks before treatment should be observed.\n4. Other invasive malignancies either currently active or active in the last 3 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin\n5. Any condition that may jeopardize patient participation in the study as well as non contraception for male and female with child-bearing potential, pregnancy or breast feeding.\n6. Patient unwilling or unable to comply with the medical follow-up required by the standard treatment taken (including PK sampling during treatment phase and vital status collection during follow-up phase) because of psychosocial, familial, social or geographical reasons\n7. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product which have a marketed authorisation, used as per the SmPC for the given indication)\n8. Patient deprived of their liberty or under protective custody or guardianship",{"count":336,"type":22},330,[148],"Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.",[340,28,341,342,343],"Digestive Cancer","Hepatocellular Carcinoma","GIST","Neuroendocrine Tumors",[345,346,347,348,349],"multi kinases inhibitors","therapeutic drug monitoring","pharmacokinetics","pharmacodynamics","advanced digestive cancers","2026-07-31",{"date":352,"type":43},"2026-08-03",{"date":354,"type":43},"2022-08-29",{"date":356,"type":22},"2027-06",{"name":358,"class":161},"UNICANCER",29,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":379,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":390},"100412938","phase-1-a-study-of-art0380-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100412938","NCT04657068","A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors","General Inclusion Criteria:\n\n* Signed informed consent\n* Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.\n* If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated\n* At least 1 radiologically evaluable lesion (measurable and\u002For non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)\n* Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor\n* Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.\n* Female patients of childbearing potential and male patients with female partners of childbearing potential are required to use highly effective contraception plus one barrier method during their participation in the study and for 7 months and 5 months respectively following the last dose. For male and female patients given gemcitabine or irinotecan, highly effective contraception plus one barrier method must be used from study entry until 6 months after the last dose of study treatment. Male patients are required to refrain from donating sperm and female patients are required to refrain from donating eggs, during their participation in the study and for 6 months following last dose.\n* Estimated life expectancy of ≥12 weeks\n* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Performance status of 0-1 on the ECOG Scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A1):\n\n* Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study\n* Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A2):\n\n•Advanced or metastatic cancer for which gemcitabine is an appropriate treatment. Prior treatment with gemcitabine is permitted.\n\nAdditional inclusion criteria for participants in dose escalation (Part A3):\n\n* Advanced or metastatic cancer for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For food effect cohort only: Patients must be able to eat a high-fat meal within a 30 minute period, as provided by the study site.\n\nAdditional inclusion criteria for participants in dose expansion (Part B1):\n\n* Patients with advanced or metastatic solid tumors with alterations to the ATM gene likely to predict for loss of ATM protein\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n* For France only ART0380 Monotherapy; Patient that is not eligible for curative treatment, for whom all standard of care therapies have failed and no therapies known to provide clinical benefit are available.\n* Combination arms; Patients for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For Spain only ART0380 Combination therapy, Patient that is not eligible for curative treatment, for whom standard of care therapies have failed.\n\nAdditional inclusion criteria for participants in dose expansion (Part B2):\n\n* Patients with a known germline BRCA mutation, or a cancer with a known somatic BRCA mutation, or which is known to be HRD positive, and for which there is an approved PARP inhibitor should have received such treatment before participating in the study, unless contra-indicated.\n* Females with histologically-confirmed diagnosis of high grade serous carcinoma of the ovary, fallopian tube or primary peritoneum that is not amenable to curative therapy\n* Platinum-resistant disease. Patients must not have had primary platinum-refractory disease (disease that progressed during first-line platinum-based therapy).\n* No more than one prior regimen in the platinum-resistant setting. Hormonal therapies and antiangiogenic therapies (as single agents) and PARP inhibitors used as maintenance therapy are not considered as separate lines of therapy. Patients should have previously received bevacizumab and chemotherapy unless contra-indicated.\n* Have not received prior treatment with gemcitabine unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n\nInclusion criteria specific to Part B3\n\n* Persistent or recurrent endometrial cancer with biological selection.:\n* Patients should have received taxane\u002Fplatinum chemotherapy, unless contraindicated.\n* Measurable disease.\n\nInclusion criteria specific to Part B4\n\n* Advanced or metastatic solid cancers of any histology with biological selection\n* If a PD-1\u002FPDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study.\n* Radiologically evaluable disease\n* Performance status of 0-1 on the ECOG scale\n\nInclusion criteria specific to Part B5\n\n* Metastatic CRC with alterations to the ATM gene\n* Participants should have previously received appropriate prior lines of therapy in this setting.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1.\n* Patients have received a maximum of 2 prior chemotherapy regimens for the treatment of CRC.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n* ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.\n* Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease\n\nInclusion criteria specific to Part B6:\n\n* Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene\n* Participants must have received at least 1 prior chemotherapy regimen for the treatment of the advanced disease OR have received neoadjuvant\u002Fadjuvant therapy with recurring occurring \\\u003C6 months following completion of this treatment.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Previously irradiated lesions may not be considered target lesions.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n* ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.\n* Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease.\n\nGeneral Exclusion Criteria:\n\n* Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment\n* Men who plan to father a child while in the study or within5 months after the last administration of study treatment\n* Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV\u002FAIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission\n* Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).\n* Moderate or severe cardiovascular disease\n* Valvulopathy that is severe, moderate, or deemed clinically significant\n* Documented major electrocardiogram (ECG) abnormalities which are clinically significant\n* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment\n* Received a live vaccine within 30 days before the first dose of study treatment\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate\n* Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study\n* Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks before the first dose of study treatment.\n* A significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment\n* Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study\n\nAdditional exclusion criteria for participants in dose escalation (Part A3, B1, B5, and B6 in combination with irinotecan):\n\n* Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening.\n* Patients who are known to be homozygous for both UGT1A1 \\*6 and \\*28 (UGT1A1 7\u002F7 genotype), or simultaneously heterozygous for both UGT1A1 \\*6 and \\*28.\n* Patients receiving strong inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment\n* Part A3 Fed-fasted cohort only: Patients receiving acid reducing agents within 1 week before the first dose of study treatment will be excluded\n* Part B6: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer\n* Parts B5 and B6: Initiation of opioids in the previous 2 weeks.\n* Parts B5 and B6: Weight loss \\>10% in the previous 8 weeks.\n* Parts B5 and B6: Active intestinal obstruction, ileus, or significant malabsorption.",{"count":224,"type":22},[172,25],"This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:\n\n* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan\n* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan\n* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan",[371,372,373,374,375,376,28,377,378],"Advanced Cancer","Metastatic Cancer","Ovarian Cancer","Primary Peritoneal Cancer","Fallopian Tube Cancer","Endometrial Cancer","Pancreatic Ductal Adenocarcinoma","Acinar Cell Carcinoma",[380],"Loss of Ataxia Telangiectasia Mutated (ATM) protein","2026-07-29",{"date":383,"type":43},"2026-07-30",{"date":385,"type":43},"2021-01-27",{"date":387,"type":22},"2028-06",{"name":389,"class":80},"Artios Pharma Ltd",82,{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":51},"100540764","phase-2-ice-study-combination-of-irinotecan-plus-cetuximab-and-envafolimab-as-a-rechallenge-regimen-in-mcrc-100540764","NCT06321081","ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC","ICE Study: a Clinical Study of the Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC","Inclusion Criteria:\n\n* Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.\n\nMale or female subjects aged ≥ 18 years. Histologically proven diagnosis of colorectal adenocarcinoma. Diagnosis of metastatic disease. RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at screening (according to NGS) Efficacy of any front-line therapies containing cetuximab or irinotecan with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1)..\n\nMore than 2 months since the last dose of cetuximab administered in first line treatment before randomization.\n\nMeasurable disease according to RECIST criteria v1.1. ECOG PS of 0 to 1 at trial entry. Estimated life expectancy of more than 12 weeks. Adequate hematological function defined by white blood cell (WBC) count ≥ 2.5 × 109\u002FL with absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, lymphocyte count ≥ 0.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, and hemoglobin ≥ 9 g\u002FdL (may have been transfused).\n\nAdequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all subjects or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).\n\nAdequate renal function defined by an estimated creatinine clearance \\> 30 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method).\n\nEffective contraception for both male and female subjects throughout the study and for at least 2 months after last study treatment administration if the risk of conception exists (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use effective contraception, defined as 2 barrier methods, or 1 barrier method with a spermicide, an intrauterine device, or use of oral female contraceptive. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately).\n\nExclusion Criteria:\n\n* Any contraindication to cetuximab and\u002For envafolimab. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.\n\nPregnancy. Breastfeeding. Participation in a clinical study or experimental drug treatment within 30 days before enrollment.\n\nSubjects receiving immunosuppressive agents (such as steroids) for any reason, should be tapered off these drugs before initiation of the trial treatment, with the exception of:\n\nSubjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ≤ 10 mg prednisone daily Intranasal, inhaled, topical steroids, Local steroid injection (e.g., intra-articular injection) Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) No ongoing neurological symptoms related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) Prior organ transplantation, including allogeneic stemcell transplantation\n\nSignificant acute or chronic infections including, among others:\n\nKnown history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome\n\nActive autoimmune disease that might deteriorate when receiving an immunostimulatory agent:\n\nSubjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.\n\nSubjects requiring hormone replacement with corticosteroids are eligible if steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or equivalent prednisone per day.\n\nAdministration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable.\n\nActive infection requiring systemic therapy. Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be ≤ 10 mg per day of equivalent prednisone.\n\nKnown severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).\n\nHistory of hypersensitivity to Polysorbate 80 that led to unacceptable toxicity requiring treatment cessation.\n\nPersisting toxicity related to prior therapy of Grade \\> 1 NCI- CTCAE v 5.0. Known alcohol or drug abuse. Clinically significant (that is active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.\n\nHistory of keratitis, ulcerative keratitis or severe dry eye. Since contact lent use is also a risk factor for keratitis and ulceration, it is not recommended.\n\nOther severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n\nLegal incapacity or limited legal capacity.",{"count":170,"type":22},[25],"This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS\u002FBRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.",[402,28,403],"RAS Mutation","MSS","2026-07-26",{"date":406,"type":43},"2026-07-28",{"date":408,"type":43},"2024-03-01",{"date":410,"type":22},"2026-12-30",{"name":412,"class":413},"Beijing Hospital","OTHER_GOV",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":249,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":51},"100648267","phase-2-phase-2-trial-of-s-531011-with-radscopal-in-previously-treated-metastatic-colorectal-cancer-100648267","NCT07720115","Phase 2 Trial Of S-531011 With RadScopal In Previously Treated Metastatic Colorectal Cancer","Eligibility Criteria\n\n1. Age ≥18 years\n2. Histologically or cytologically confirmed non-MSI-H colorectal adenocarcinoma with metastatic or locally advanced unresectable disease.\n3. Anticipated life expectancy greater than 3 months.\n4. Prior receipt of fluoropyrimidine, oxaliplatin, and irinotecan as standard-of-care chemotherapy.\n5. Presence of measurable disease per RECIST v1.1.\n6. Participants must have at least two target lesions amenable to treatment with RadScopalTM XRT, with at least one lesion amenable to HD-XRT (50 Gy in 4 fractions or 30 Gy in 5 fractions) as determined by the treating radiation oncologist. Repeat radiation with LDXRT to previously irradiated sites will be allowed at the discretion of the treating radiation oncologist.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n8. Adequate organ and marrow function as defined below:\n\n   * Absolute neutrophil count ≥1,500\u002FmcL\n   * Hemoglobin ≥9 g\u002FdL\n   * Platelets ≥100,000\u002FmcL\n   * AST and ALT ≤3x institutional upper limit (ULN). If liver enzyme abnormalities are due to underlying liver metastases, AST and ALT ≤ 5x institutional ULN Total serum bilirubin \\\u003C1.5x institutional ULN (unless Gilbert disease confirmed)\n   * Creatinine clearance ≥ 45 ml\u002Fmin by Cockcroft-Gault Formula\n9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n10. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n11. Human immunodeficiency virus (HIV)-infected participants on anti-retroviral therapy with undetectable viral load within 6 months of study enrollment are eligible.\n12. Participants should be willing to use contraception for a significant period after treatment to avoid potential harm to a fetus from residual drug exposure or genetic damage. Women of childbearing potential and men with a female partner of childbearing potential must be willing to use effective methods of contraception during the duration of study participation, and for 6 months after completion of S-531011 administration, as follows:\n\n    * Women: willing to use contraceptives with a failure rate \\\u003C1% per year when used consistently and correctly, eg, combined oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, or intrauterine device, sexual abstinence, or a vasectomized partner. Definitions that meet the criteria to not be considered of childbearing potential:\n\n      * Women \\>1 year postmenopausal (defined as 1 year or longer since last menstrual period) AND \\>55 years of age\n      * Postmenopausal women (as defined above) and \\\u003C55 years of age with a negative pregnancy test within 1 week of first dose of S-531011.\n      * Women who underwent surgical sterilization at least 3 months prior to enrollment.\n    * Men: willing to use adequate contraception treatment during the duration of study participation and for 6 months after completion of S-531011 administration. In addition, men must refrain from donating sperm during this period.\n\n14\\. Ability to understand and the willingness to sign a written informed consentdocument and to comply with study visits.\n\nExclusion Criteria\n\n1. Prior treatment with an anti-CCR8 antibody.\n2. Tumor occupying \\>80% of total liver volume, as assessed by the investigator and\u002For treating radiation oncologist.\n3. Prior XRT to the target lesion(s) selected for HD-XRT.\n4. Prior organ or tissue allograft.\n5. Presence or history of immunodeficiency that requires chronic use of systemic corticosteroids (≥ 10mg of prednisone equivalent per day) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n6. 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).\n\n   Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n7. Any anticancer therapy within the past 4 weeks before enrollment.\n8. Extended field radiation within the past 4 weeks or limited field radiation within the past 2 weeks before enrollment.\n9. Participants who have not recovered from adverse events due to prior anticancer therapy (i.e. \\>grade 2 residual toxicities) with the exception of alopecia and platinum-induced peripheral neuropathy.\n10. Active brain metastases, unless adequately treated and participant is neurologically stable (except for residual symptoms of central nervous system treatment) for at least 2 weeks prior to enrollment without corticosteroids or are on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent).\n11. Presence of symptomatic leptomeningeal disease.\n12. Clinically significant cardiac, respiratory, or other medical or psychiatric conditions that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator.\n13. Pregnant women are excluded from this study because S-531011 is an agent with the potential for teratogenic or abortifacient effects.",{"count":421,"type":22},30,[25],"To learn if the experimental drug S-531011 plus RadScopalTM radiation therapy can help to control previously treated metastatic colorectal cancer.",[425,426,427,28],"Phase II","S-531011","RadScopal","2026-07-23",{"date":430,"type":43},"2026-07-24",{"date":432,"type":22},"2027-01-07",{"date":434,"type":22},"2031-01-01",{"name":436,"class":161},"M.D. Anderson Cancer Center",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":304},"100648187","phase-2-immunotheray-combined-with-simvastatin-and-target-therapy-and-chemotharepy-for-advanced-colorectal-cancer-100648187","NCT07718490","Immunotheray Combined With Simvastatin and Target Therapy and Chemotharepy for Advanced Colorectal Cancer","A Multicenter, Prospective, Phase II Exploratory Study on the First-line Treatment of MSS\u002F PMMR-type Advanced Colorectal Cancer With Adebrelimab Combined With Simvastatin and Targeted and Chemotherapy","Inclusion Criteria:\n\n1. Able to provide written informed consent and voluntarily participate in this study.\n2. Male or female subjects aged between 18 and 75 years, inclusive.\n3. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.\n4. No prior systemic anti-tumor therapy; patients who have received neoadjuvant\u002Fadjuvant therapy are eligible if the time from the last chemotherapy to recurrence or progression is more than 6 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Expected survival of at least 3 months.\n7. Presence of at least one measurable lesion at baseline assessed by the investigator according to RECIST 1.1. Measurable lesions must not have been previously treated with radiotherapy or other local therapy, unless the lesion located in a previously irradiated area has been confirmed to have progressed.\n8. Adequate organ function as defined below (no blood products or hematopoietic growth factors are allowed within 14 days prior to the first dose of study treatment):\n\n   * Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL\n   * Platelet count ≥100×10\\^9\u002FL\n   * Hemoglobin ≥9 g\u002FdL\n   * Serum albumin ≥2.5 g\u002FdL\n   * Total bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases\n   * Serum creatinine ≤1.5 × ULN, or creatinine clearance \\>60 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n   * Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5 × ULN. Subjects receiving stable-dose anticoagulation such as low molecular weight heparin or warfarin with INR within the expected therapeutic range are eligible.\n9. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment, must not be breastfeeding, and must agree to use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 6 months after the last dose of study treatment. Male subjects with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose of study treatment, and must not donate sperm during the study period.\n\nExclusion Criteria:\n\n1. Received local radiotherapy within 4 weeks prior to the first dose of study drug, and adverse events due to radiotherapy have not recovered to baseline levels. Subjects who received palliative radiotherapy to peripheral sites (e.g., bone metastases) more than 4 weeks prior to the first dose are eligible, provided they have recovered from any acute adverse reactions.\n2. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they have stable brain metastases and have not required steroid treatment for brain metastases for at least 28 days prior to study entry. This exception does not apply to carcinomatous meningitis, which is excluded regardless of clinical stability.\n3. Major surgery, open biopsy, or severe trauma within 28 days prior to the first dose of study drug.\n4. History of allergy to any anti-angiogenic agents, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.\n5. Uncontrolled hypertension despite anti-hypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n6. Subjects with uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular or ventricular arrhythmias without clinical intervention or still poorly controlled after clinical intervention.\n7. Significant clinically relevant bleeding symptoms or clear bleeding tendency within 3 months prior to the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis.\n8. Arterial\u002Fvenous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. Superficial venous thrombosis may be included at the investigator's discretion.\n9. Presence of another progressing or actively treated malignancy, except for non-melanoma skin cancer and cervical carcinoma in situ that have received curative treatment.\n10. Subjects with other factors that, in the investigator's opinion, may lead to premature discontinuation of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, clinically significant laboratory abnormalities, family or social factors that may affect subject safety or trial data collection.","75 Years",{"count":446,"type":22},43,[25],"Metastatic colorectal cancer with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) molecular phenotypes could significantly benefit from immune checkpoint inhibitor therapy, ushering in the MSI era of immunotherapy for colorectal cancer. However, MSI-H\u002FdMMR is present in only 15%-20% of stage II\u002FIII and 5% of stage IV colorectal cancer patients, while the vast majority of patients exhibit microsatellite stability (MSS) or proficient mismatch repair (pMMR) types, which are insensitive to immunotherapy. Therefore, how to enhance the efficacy of immunotherapy in the pMMR\u002FMSS population through combination therapy has become a hotspot and challenge in colorectal cancer research.",[28],"2026-07-17",{"date":452,"type":43},"2026-07-22",{"date":454,"type":43},"2025-09-01",{"date":254,"type":22},{"name":457,"class":161},"The First Affiliated Hospital with Nanjing Medical University",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":51},"100585820","phase-2-testing-a-functional-precision-medicine-approach-to-select-chemotherapy-for-metastatic-colorectal-cancer-cosense-1-100585820","NCT06907342","Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1)","COSENSE-1: A Feasibility Study for Using a Functional Precision Medicine Platform to Select Oxaliplatin-based Versus Irinotecan-based Chemotherapy Regimens for Patients With Metastatic Colorectal Cancer","COSENSE-1","Inclusion Criteria:\n\nGeneral conditions:\n\n1. Age 18 or older\n2. ECOG performance status 0 or 1\n3. Obtained informed consent\n4. Acceptable organ function (defined in publicly available protocol)\n5. Women of child-bearing potential and men must agree to use highly effective contraception (defined in publicly available protocol)\n\n   Disease and treatment specific conditions:\n6. Histologically confirmed pMMR\u002FMSS adenocarcinoma originating from the colon or rectum\n7. Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion)\n8. Patient has metastatic or primary lesion available for biopsy\n9. Patient has measurable or evaluable disease per RECIST (version 1.1)\n10. The oxaliplatin-based regimen FOLFOX (+\u002F- antibody) versus the irinotecan-based regimen FOLFIRI (+\u002F- antibody), are evaluated by an experienced physician, independent of inclusion in the trial, to be equally recommended for the participant as standard of care first-line therapy in the treatment of mCRC, following the Norwegian national guideline on the treatment of colorectal cancer (https:\u002F\u002Fwww.helsedirektoratet.no\u002Fretningslinjer\u002Fkreft-i-tykktarm-og-endetarm-handlingsprogram)\n11. Patient is eligible for full (100%) chemotherapy doses at first treatment cycle\n12. Treatment with chemotherapy can be scheduled within 28 days from referral\n\nExclusion Criteria:\n\n1. Patient has metastatic MMR deficient\u002FMSI adenocarcinoma\n2. Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle\n3. Patient is not equally eligible for FOLFOX (+\u002F- antibody) and FOLFIRI (+\u002F- antibody) chemotherapy regimens, according to the Norwegian national guideline on the treatment of colorectal cancer\n4. ECOG performance status 2 or worse\n5. Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus\n6. Breastfeeding\n7. Patients with psychological, geographical, familial or sociological conditions that can prevent compliance with the study protocol\n8. Inability to understand study procedures and comply with them, or disorder that compromises the patient's ability to provide informed consent and\u002For comply with study procedures\n9. Patient fulfils any of the contraindications listed in the SmPC of the relevant IMP\n10. Treatment cannot be scheduled within 28 days from referral\n\n    Medical history:\n11. Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency\n12. Evidence of CNS metastasis\n13. Unresolved toxicities of a previous systemic treatment that, in the opinion of the physician, make the patient unfit for inclusion\n14. Antitumoural treatment ≤ 30 days before inclusion. Hormonal substitutive treatment is allowed\n15. Preexisting significant cardiovascular disease including uncontrolled\u002Funstable or symptomatic angina, uncontrolled atrial or ventricular arrythmias, LVEF known to be \\\u003C 40% or symptomatic congestive heart failure\n16. Stroke (including TIA) or acute myocardial infarction within 6 months before the first dose of study treatment\n17. Clinically significant peripheral sensory neuropathy\n18. Recent (\\\u003C6 months before the start of study treatment) pulmonary embolism, deep vein thrombosis, or another significant thromboembolic event\n19. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on chest computed tomography (CT)\n20. Evidence of previous acute hypersensitivity reaction to any component of the treatment\n21. History of any disease that may increase the risks associated with study participation",{"count":467,"type":22},148,[25],"COSENSE-1 is an unblinded, phase II, single-armed, single center feasibility study for using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens, for male and female participants aged 18 and older, with microsatellite stable (MSS)\u002Fproficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC), that is incurable or not resectable with curative intent.",[471,472,473,28,474,475],"Tumor, Colorectal","Organoids","Tumoroid","Core Needle Biopsy","First-line Treatment",{"date":477,"type":43},"2026-07-20",{"date":479,"type":43},"2025-05-23",{"date":481,"type":22},"2040-09",{"name":483,"class":161},"St. Olavs Hospital",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":246,"phases":4,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100637435","primary-and-acquired-resistance-to-targeted-treatment-in-braf-v600e-mutated-metastatic-colorectal-cancer-100637435","NCT07617610","Primary and Acquired Resistance to Targeted Treatment in BRAF V600E-mutated Metastatic Colorectal Cancer","Primary and Acquired Resistance to Targeted Treatment in BRAF V600E-mutated Metastatic Colorectal Cancer (PARTACER-Suisse)","PARTACER","Inclusion Criteria:\n\n* Diagnosis of unresectable or metastatic BRAF V600E-mutated colorectal cancer\n* Planned initiation of treatment with combined anti-EGFR antibody and BRAF inhibitor\n* Patients receiving treatment in any line, with or without chemotherapy\n* At least one tumor lesion accessible for biopsy\n* ECOG performance status 0-2\n* Life expectancy of at least 3 months\n* Age ≥18 years\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Medical or surgical contraindication for tumor biopsy\n* Active second malignancy (except non-melanoma skin cancer)\n* Inability to comply with study procedures (e.g., due to language barriers or cognitive impairment)\n* Pregnancy or breastfeeding\n* Previous treatment with a BRAF inhibitor",{"count":421,"type":22},"This study prospectively investigates the molecular mechanisms of primary and acquired resistance to standard-of-care BRAF V600E-directed therapy in patients with metastatic colorectal cancer and aims to pre-clinically develop novel strategies to reverse therapy resistance. Clinically approved combination treatment with cetuximab, encorafenib and chemotherapy improves patient outcomes, yet patients eventually experience disease progression. In this prospective multicenter study, tumor tissue, blood, and stool samples will be collected before treatment and at progression, to identify genetic and non-genetic mechanisms of resistance. Additionally, tumor tissue-based in vitro models (patient-derived organoids, PDOs) will be generated and exploited for functional in vitro testing, including genomic and pharmacologic perturbation studies. The overarching goal is to generate knowledge that can help develop new and more effective treatment strategies for future patients.",[28,495],"BRAF V600E Mutation",[28,497,498,499,500,501,502,503,504,505,506,507,508,509,510,511],"mCRC","BRAF V600E","Targeted therapy resistance","Encorafenib","Cetuximab","EGFR inhibition","BRAF inhibition","Liquid biopsy","Precision oncology","Patient-derived organoids","Circulating tumor DNA","ctDNA","Microbiome","Comprehensive genomic profiling","SCI\u002FSAKK","2026-07-15",{"date":514,"type":43},"2026-07-16",{"date":516,"type":43},"2025-05-25",{"date":518,"type":22},"2030-09",{"name":520,"class":161},"Swiss Cancer Institute",13,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":534,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":551},"100599064","phase-1-a-clinical-study-to-test-if-an-investigational-treatment-called-bnt314-when-used-in-combination-with-another-investigational-treatment-pumitamig-bnt327-and-chemotherapy-is-beneficial-and-safe-for-patients-with-advanced-colorectal-cancer-100599064","NCT07079631","A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer","A Phase I\u002FII, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With Pumitamig and Chemotherapy in Participants With Metastatic Colorectal Cancer","Key Inclusion Criteria:\n\n* Have unresectable histologically confirmed adenocarcinoma of the colon or rectum.\n* Have confirmed non-microsatellite instability-high (non-MSI-H)\u002FpMMR mCRC per Food and Drug Administration (FDA)\u002FEuropean Commission (EC) approved test or based on local testing.\n* Have measurable disease defined by RECIST v1.1.\n* Must provide a tumor tissue sample (formalin-fixed, paraffin-embedded or tissue slides) collected before C1D1 for enrollment. A newly obtained tumor sample is preferred. If it is not feasible to obtain a recent tumor sample, participants can provide archival tumor tissue (less than 2 years prior treatment).\n* Have Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Have a life expectancy of ≥12 weeks.\n* Have an adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol.\n* Have had an adequate previous treatment washout period before randomization\u002Fenrollment as defined in the protocol.\n\nInclusion criteria applicable to only protocol-specific cohorts:\n\n* Have histologically confirmed metastatic colorectal cancer and radiographically documented disease progression after ≥2 prior lines of systemic therapy for metastatic disease as defined in the protocol.\n* Have progressed following first-line chemotherapy as specified in the protocol.\n* Have not received prior systemic therapy for MSS\u002FpMMR mCRC. Participants who received chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease in the neoadjuvant or adjuvant setting are eligible for the study if therapy was completed at least 6 months prior to initiation of study treatment.\n\nOther cohort-specific inclusion criteria apply.\n\nKey Exclusion Criteria:\n\n* Confirmed MSI-H\u002Fdeficient mismatch repair mCRC (per FDA\u002FCE approved test or based on local testing).\n* Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted or immunotherapy.\n* Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD\\[L\\]-1)\u002Fvascular endothelial growth factor bispecific antibody.\n* Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as \"radical\" intent), per investigator's assessment.\n* Have uncontrolled or significant cardiovascular disease as specified in the protocol.\n* Have left ventricular ejection fraction \\\u003C50% by echocardiogram or multigated acquisition within 28 days before randomization\u002Fenrollment.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Participants with untreated, asymptomatic brain metastases for whom local therapy is not indicated per SoC may be eligible if neurologically stable and (if deemed necessary by the investigator). Except for brain metastases history, any participants at imminent risk for spinal cord compression or leptomeningeal disease are not eligible.\n* Have unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline toxicities that have resolved with sequelae (e.g., tracheostomy, chronic use of feeding tube, replacement hormones) are allowed, if not associated with increased risk of complications per investigator's assessment.\n* Participants in Part B or C who fulfill one of the conditions:\n\n  * Prior treatment with anticancer therapies (as defined in the protocol) with unusual toxicity, or\n  * Known dihydropyrimidine dehydrogenase (DPD) deficiency, testing performed according to the local guidelines. If not tested, lack of DPD activity must be tested for the participants who have not received anticancer therapies (as defined in the protocol) in the prior lines of treatment; testing should be performed according to the local guidelines.\n* Have a history of another primary malignancy within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated (adjuvant hormone therapy for malignancies at low risk of relapse is allowed) or have a known additional malignancy that is progressing or requires treatment.\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have 24-h urine protein excretion ≥1 g. If qualitative urine protein is ≤1+, a 24-h urine protein quantitative test is not required.\n* Have active autoimmune disease or a history of autoimmune disease (myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, vasculitis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis) with a risk of exacerbation following PD-L1 inhibition or have an immune deficiency (allogeneic hematopoietic stem cell transplantation or organ transplantation). Participants with protocol-specified conditions may be eligible.\n* Have serious non-healing wounds, ulcers, or bone fractures. This includes history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, acute gastrointestinal bleeding for which an interval of 6 months must pass before enrollment into this study. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Have evidence of major coagulation disorders or other significant risks of hemorrhage as specified in the protocol.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":530,"type":22},482,[172,25],"This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002) and chemotherapy in participants with metastatic colorectal cancer (mCRC).",[28],[535,536,537,538,539,123,540,541],"Microsatellite stable or mismatch repair proficient (MSS\u002FpMMR) tumors","Immune checkpoint inhibitor","Programmed death-ligand 1 (PD-L1)","Vascular endothelial growth factor-A (VEGF-A)","Bispecific antibody","Combination chemotherapy","Dose optimization","2026-06-30",{"date":544,"type":43},"2026-07-01",{"date":546,"type":43},"2025-07-18",{"date":548,"type":22},"2032-12",{"name":550,"class":80},"BioNTech SE",14,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":304},"100547763","phase-1-a-multicenter-phase-1b2-study-of-adagrasib-cetuximab-and-cemiplimab-for-metastatic-colorectal-cancer-harboring-kras-g12c-mutations-100547763","NCT06412198","A Multicenter Phase 1b\u002F2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of advanced\u002Fmetastatic microsatellite stable colorectal cancer with KRASG12C mutation with 1+ prior line(s) of therapy\n* Confirmed KRASG12C mutation status. If a molecular profiling report is not available, a representative paraffin-embedded tumor block or a minimum of 10 unstained slides will be requested for retrospective KRASG12C mutation testing.\n* Unresectable or metastatic disease.\n* Participants must have received at least one prior line of chemotherapy for metastatic disease with progression on treatment or intolerance to therapy.\n* Presence of measurable disease per RECIST 1.1\n* Willingness to participate in on-study related procedures, including mandatory biopsies (one baseline and one on-treatment biopsy).\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of the proposed combination in patients \\\u003C18 years of age, children are excluded from this study.\n* Able to take oral medications.\n* Most recent prior systemic therapy (e.g., chemotherapy, immunotherapy or investigational agent) and radiation therapy discontinued at least 7 days before first dose.\n* Recovery from the treatment-related adverse effects of prior therapy at the time of enrollment to ≤ Grade 1 (excluding alopecia and prior oxaliplatin-induced neuropathy).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values within the screening period:\n\n  * Absolute neutrophil count ≥ 1,000\u002Fmm3 (≥ 1.0 x 109\u002FL)\n  * Platelet count ≥ 100,000\u002Fmm3 (≥ 100 x 109\u002FL)\n  * Hemoglobin ≥ 9 g\u002FdL, in the absence of transfusions for at least 2 weeks\n  * Total bilirubin ≤ 1.5x upper limit of normal (ULN) (if associated with Gilbert's disease or UGT1A1\\*28 homozygosity, ≤ 3x ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0x ULN (if associated with liver metastases ≤5x ULN)\n  * Calculated creatinine clearance (determined as per Cockcroft-Gault) ≥ 60mL\u002Fmin at screening\n* Completed informed consent process, including signing of IRB-approved informed consent form.\n* Willing and able to comply with clinical trial instructions and requirements. Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation.\n* Participants who are biologically capable of having children and sexually active must agree to use an acceptable method of contraception for the duration of the treatment period and for at least 6 months after the last dose of study treatment. The Investigator will counsel the patient on selection of contraception method and instruct the participant in its consistent and correct use. Examples of acceptable forms of contraception include:\n\n  * Oral, inserted, injected or implanted hormonal methods of contraception, provided it has been used for an adequate period of time to ensure effectiveness.\n  * Correctly placed copper containing intrauterine device (IUD).\n  * Male condom or female condom used WITH a spermicide.\n  * Male sterilization with confirmed absence of sperm in the post-vasectomy ejaculate.\n  * Bilateral tubal ligation or bilateral salpingectomy.\n* The Investigator will instruct the participant to call immediately if the selected birth control method is discontinued or if pregnancy is known or suspected.\n\n  * Note: Women are considered post-menopausal and\u002For not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 months ago. In case of any ambiguity, the reproductive status of the woman should be confirmed by hormone level assessment.\n\nExclusion Criteria:\n\n* Prior PD1 or CTLA4 inhibition therapy\n* Prior KRASG12C inhibition therapy\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n* 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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Active brain metastases, unless adequately treated and participant is neurologically stable (except for residual symptoms of central nervous system treatment) for at least 2 weeks prior to enrollment without corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)\n* Ongoing need for a medication with any of the following characteristics that cannot be switched to alternative treatment within 10 days prior to study entry: known risk of QTc prolongation or Torsades de Pointes; substrate of CYP3A with a narrow therapeutic index; strong inducer or inhibitor of CYP3A and\u002For P-gp; strong inhibitor of BCRP; strong inhibitor or inducer of CYP2C19; and proton pump inhibitors.\n\nNote: one dose of propofol, midazolam, and\u002For fentanyl under a monitored setting during IR guided biopsies is allowed.\n\n* Pregnancy. Women of child-bearing potential must have a negative serum or urine pregnancy test during screening\n* Breast-feeding or planning to breast feed during the study or within 6 months after end of treatment.\n* Participants with symptomatic leptomeningeal disease.\n* Major surgery within 4 weeks of first dose of any study drug.\n* History of intestinal disease or major gastric surgery likely to alter absorption of study treatment, to be determined by the treating physician\n* Known human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B (HBV) or C (HCV) infection as tested in a CLIA certified lab using a positive HIV antibody test. For Hepatitis B and C, an antigen that is drawn and positive. Note that the following are permitted:\n* Participants treated for HIV with no detectable viral load on current regimen for at least 1 month prior to randomization;\n* Note: Please refer to exclusion criteria regarding drug-drug interactions of concomitant anti-HIV agents, and in particular CYP3A substrates.\n* Participants with prior HBV infections who are:\n* considered to have past or resolved HBV infection, defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of hepatitis B surface antigen \\[HBsAg\\]; or\n* considered to be in an inactive HBV carrier state, defined as HBsAg-positive with normal ALT, and HBV DNA \\\u003C 2,000 IU\u002FmL or \\\u003C 10,000 copies\u002FmL;\n* Note: For participants in an inactive HBV carrier state or with a resolved HBV infection, the risk of HBV reactivation should be considered and the need for anti-HBV prophylaxis prior to randomization should be carefully assessed in accordance with local guidelines.\n* Participants treated for HCV with no detectable viral load.\n* Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with the participant's participation in the study, or with the interpretation of results.",{"count":559,"type":22},31,[172,25],"To learn if the drug combination of adagrasib, cetuximab, and cemiplimab can help to control metastatic CRC with KRAS G12C mutations.",[28,563],"KRAS G12C Mutations","2026-06-24",{"date":566,"type":43},"2026-06-26",{"date":568,"type":43},"2024-08-28",{"date":570,"type":22},"2029-03-01",{"name":436,"class":161},{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":583,"conditions":584,"keywords":587,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":51},"100612598","phase-1-a-fih-phase-iiia-trial-assessing-feasibility-of-administrations-of-til-based-immunotherapy-in-patients-with-metastatic-crc-and-pc-100612598","NCT07255664","A FIH, Phase I\u002FIIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC","A FIH, Phase I\u002FIIa, Open-label Trial Assessing Safety, Tolerability, and Feasibility of Repeated Administrations of a Novel Autologous TIL-based Immunotherapy in Patients With Metastatic Colorectal or Prostate Cancer","ProbeTILity","Inclusion Criteria:\n\n* Patient (female or male) has signed informed consent according to ICH\u002FGCP and national\u002Flocal regulations prior to any trial-specific procedure.\n* Patient is 18 years or older at the time of signing the informed consent form.\n* Patient must live in an area where a hospital for care can be reached within a maximum of 50 km.\n* Patient has histological or cytological confirmation of:\n\n  * colorectal cancer, which is stage IV (any T \u002F any N \u002F M1), not amenable to curative surgery, OR\n  * prostate cancer, which is stage III locally advanced, not amenable to curative surgery (T3-4 \u002F N0 \u002F M0 or any T \u002F N1 \u002F M0), or stage IV metastatic (any T \u002F any N \u002F M1)\n* Patient has received all lines of therapy that\n\n  * are considered SOC for the patient's indication according to applicable European\u002Fnational professional society medical guidelines and local medical practice at time of enrollment\n  * are available via the national health insurance system and the patient is considered eligible for but led to insufficient response or were medically not justified or refused by the patient.\n* Patient has confirmed disease progression by radiologic imaging from the previous line of therapy.\n* Patient has sufficient amount of previously not irradiated tumor tissue in adequate quality for TIL harvest and expansion, i.e., either:\n\n  * Primary or metastatic lesion has been selected for surgery (e.g., to reduce tumor burden, pain relief), Or\n  * Patient has consented to surgery for the purpose of tissue harvesting for TIL expansion and is considered suitable to undergo surgery for this purpose. Note: Patients with a non-justifiable anesthesiologic and\u002For surgical risk, as determined by the investigator, should be excluded\n* Patient has a least one measurable or assessable lesion according to RECIST 1.1 remaining after tumor resection for CC-38 manufacturing has been performed.\n* Patient has ECOG performance status of 0 or 1.\n* Patient has a minimum life expectancy of 6 months in the opinion of the investigator from the time of consent date.\n* Patient has adequate bone marrow, hepatic and renal function in the opinion of the investigator:\n\n  1. Hemoglobin ≥ 9.0 g\u002FdL,\n  2. Absolute neutrophil count (ANC) ≥ 1.0 x 109 \u002FL,\n  3. Platelets ≥ 80 x 109 \u002FL,\n  4. Calculated creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula),\n  5. Serum bilirubin ≤ 1.5 x ULN (or ≤ 2.5 x ULN in the presence of documented Gilbert's Syndrome \\[unconjugated hyperbilirubinemia\\] or liver metastases),\n  6. AST\u002F ALT and alkaline phosphatase ≤ 2.5 x ULN (or ≤5 times ULN in the presence of bone and\u002For liver metastases), ALP ≤ 2.5 x ULN,\n  7. International normalized ration (INR) ≤ 1.5 or prothrombin time (PT) ≤ ULN + 4 seconds.\n* Female patients must be post-menopausal or use contraceptive methods with a failure rate of \\\u003C 1% 6 months after last administration of CC-38, whatever is later, to prevent pregnancy. Male patients with fertile female partners must be willing to use condoms with spermicide, and the fertile partner must use contraceptive methods with a failure rate of \\\u003C 1% for the same time period. Male patients must also refrain from donating sperm for the same time period.\n* Successful tumor tissue sampling by surgery, including presence of TILs in the tumor tissue in the pathological evaluation.\n* Successful TIL expansion defined as obtaining the final CC-38 drug product\n\nExclusion Criteria:\n\n* Patient as any of the following condition:\n\n  1. Congestive heart failure NYHA class III or IV,\n  2. myocardial infarction or coronary artery bypass graft within 6 months prior to enrollment,\n  3. history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration,\n  4. history of severe non-ischemic cardiomyopathy,\n  5. uncontrolled blood pressure as defined as systolic \\> 160 mmHg, diastolic \\> 100 mmHg within 3 months prior to enrollment,\n  6. left ventricular ejection fraction (LVEF) \\\u003C 45% as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan,\n  7. any other clinically significant cardiovascular events such as unstable angina, angioplasty, stroke, or transient ischemic attack (TIA) within less than 6 months before enrolment,\n  8. other conditions that the treating physicians believe may endanger the health of the patients by their participation in this clinical trial.\n* Patient has any of the following pulmonary conditions:\n\n  1. Forced expiratory volume in 1 second (FEV1)\\\u003C60%,\n  2. Active obstructive chronic pulmonary disease,\n  3. oxygen dependence as defined by a blood oxygen saturation that can only be maintained above 92% by oxygen inhalation (finger oxygen detection method),\n  4. other pulmonary conditions that increase the anesthesiologic risk.\n* Patient has a current or history of central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression,\n* Patient has ulcers in the upper GI tract, untreated or incompletely treated esophageal varices with high risk of bleeding in the investigator's discretion.\n* Patient requiring therapeutic anticoagulant therapy or having other increased risk of bleeding events.\n* Patient has any severe acute or chronic medical condition that places the patient at increased risk or interferes with the interpretation of trial results in the opinion of the investigator.\n* Patient has any form of primary immunodeficiency (such as severe combined immunodeficiency disease \\[SCID\\] and acquired immune deficiency syndrome \\[AIDS\\]).\n* Patient has active or history of autoimmune or inflammatory disorders. Note: Patients may be eligible if they have been assessed in discussion between Principal Investigator, Chief Medical Officer and Senior Medical Consultant as not posing an increased risk to the patient.\n* Patient receiving immunosuppressive concomitant medications (≥ 10 mg prednisone daily or other equivalent). Steroid medications are allowed if they are used as substitution or are administrated topically or as inhalations.\n* Patient has received an organ and\u002For allogenic stem cell transplant.\n* Patient has known acute or chronic infection with hepatitis B or C virus.\n* Patient has known HIV infection (seropositive for HIV antibody).\n* Patient has known infection with syphilis.\n* Patient has known bone-marrow aplasia.\n* Patient has known (chronical) urinary tract infection and\u002F or acute urothelial toxicity from previous cytotoxic chemotherapy or radiation therapy or urinary flow obstructions.\n* Female patient, who is pregnant or breast-feeding, or plan to become pregnant within 12 months after cyclophosphamide or 6 months after last dose of CC-38, whichever last. Women of childbearing potential must have a negative pregnancy test at screening and before every CC-38 application.\n* Patient is unable to comply with trial procedures, restrictions, or requirements.\n* Patient received last previous systemic cancer treatment (including anti-testosterone treatment) within less than 4 weeks prior enrollment.\n\nNote: Bridging therapies (specified in trial design \\[section 2 - subsection: screening and TIL harvesting\\]) after TIL harvesting and before CC-38 administration are permitted after consultation between Principal Investigator, Chief Medical Officer and Senior Medical Consultant.\n\n* Patient received last palliative radiotherapy within less than 4 weeks prior enrollment - where RECIST 1.1 evaluable metastases are within the radiation area.\n* Patient received minor surgery (as judged by the investigator, i.e., port implantation) within less than 3 weeks prior enrollment.\n* Patient with AEs from previous treatment that have not recovered to CTCAE v5.0 ≤ grade 1 Note: Clinically insignificant grade 2 AEs that may be allowable if discussed between and approved by Principal Investigator, Chief Medical Officer and Senior Medical Consultant.\n* Patient participates in any other interventional clinical trial or has been treated with any investigational research products within 4 weeks prior to the initiation of screening.\n* Patient has bone metastasis only.\n* Patient has known hypersensitivity to any component of the trial regimen.\n* For colorectal cancer: Patient has been diagnosed with histologically or cytologically proven BRAF-V600 positive CRC.\n* Patient has any further contraindication to the IMP pembrolizumab or any of the auxiliary medicinal products (i.e., IL-2, cyclophosphamide, uromitexan) as per current EU SmPCs to the respective product.",{"count":581,"type":22},12,[172,25],"This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.",[28,585,586],"Prostate Cancer Metastatic","Prostate Cancer Locally Advanced",[497,588,589,123],"aPC","TIL","2026-06-18",{"date":592,"type":43},"2026-06-22",{"date":594,"type":43},"2025-11-13",{"date":596,"type":22},"2029-04",{"name":598,"class":80},"CuraCell TX AB",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":608,"briefSummary":609,"conditions":610,"keywords":621,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":645},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176","NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol",{"count":607,"type":22},392,[172],"First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[611,612,613,614,615,616,617,28,618,619,620],"Solid Tumor, Adult","Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[622,623,624,625,626,627,628,629,630,631,632,372,371,633,634,635,636],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","NSCLC","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative",{"date":638,"type":43},"2026-06-23",{"date":640,"type":43},"2024-10-29",{"date":642,"type":22},"2028-11",{"name":644,"class":80},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",40,{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":4,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":23,"phases":654,"briefSummary":655,"conditions":656,"keywords":657,"overallStatus":249,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":51},"100644338","phase-2-tovecimig-plus-folfiri-in-second-line-metastatic-colorectal-cancer-100644338","NCT07662031","Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer","A Phase 2 Clinical Trial of Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed CRC.\n* Patient must have undergone resection of his\u002Fher primary tumor either as part of treatment for early stage disease with subsequent metastatic progression or due to a tumor related complication in the metastatic setting (e.g. bowel obstruction).\n* Measurable disease per RECIST 1.1.\n* Patient must have advanced or metastatic disease, and have progressed on one line of standard of care therapy in the advanced\u002Fmetastatic setting\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN or ≤ 2.0 mg\u002FdL in presence of liver metastases\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3x IULN or ≤ 5x IULN in presence of liver metastases\n  * Creatinine clearance \\> 50 mL\u002Fmin by Cockcroft-Gault\n* The effects of Tovecimig and FOLFIRI on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of Tovecimig or any component of FOLFIRI. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Patients with MSI-H status.\n* Intact primary tumor that has not been resected.\n* More than one line of prior therapy for advanced or metastatic CRC.\n\n  \\*If FOLFIRI\u002FFOLFOXIRI was given in the first line, it must have been completed ≥ 6 months before study start date.\n* Surgery or major procedure, or systemic anticancer therapy within 4 weeks prior to C1D1.\n* Radiation therapy within 2 weeks prior to C1D1.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Receipt of any other investigational agents within 4 weeks prior to C1D1, with exception of investigational imaging agents.\n* Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.\n* Prior history of diseases\u002Fconditions that elevates the patient's risk of hemorrhage, such as a bleeding diatheses, history of prior bowel perforation, or clinically significant active bleeding (i.e. hemoptysis larger than a tablespoon within 3 weeks prior to C1D1).\n* Recent history of paracentesis (within 3 weeks prior to C1D1) or current indwelling catheter.\n* A history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Tovecimig (i.e. humanized\u002Fhuman monoclonal antibody drugs), FOFLIRI, or other agents used in the study.\n* Use of anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylaxis) purpose within 10 days of C1D1.\n* Use of aspirin, other NSAIDs (i.e. naproxen, ibuprofen), or other antiplatelet drugs within 10 days of C1D1.\n* Uncontrolled intercurrent illness\u002Finfection requiring ongoing systemic antibiotics, antivirus drugs, or other uncontrolled active acute infectious diseases.\n* A history of CHF (NYHA class II or higher) with 5 years prior to C1D1, LVEF \\\u003C 50% on screening TTE\u002FMUGA, uncontrolled hypertension (defined as SBP\u002FDBP greater than 140\u002F90 despite best supportive care at any time during screening), pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina, or any significant valvular disease.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of C1D1.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.",{"count":7,"type":22},[25],"This is an open-label Phase 2 study to evaluate the safety and efficacy of Tovecimig combined with FOLFIRI in patients who have received one prior line of therapy for advanced or metastatic colorectal cancer (CRC).",[127,28],[658,271,659],"Tovecimig","Microsatellite stable","2026-06-17",{"date":638,"type":43},{"date":663,"type":22},"2026-08-31",{"date":665,"type":22},"2032-08-31",{"name":667,"class":161},"Washington University School of Medicine",{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":674,"targetDuration":4,"studyType":23,"phases":676,"briefSummary":678,"conditions":679,"keywords":4,"overallStatus":249,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":51},"100617420","early-phase-1-ascend-crc-profiling-and-targeting-dynamic-tumor-resistance-in-patients-with-metastatic-colorectal-cancer-100617420","NCT07318389","ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer","Eligibility Criteria\n\n* The participant has a histologically or cytologically confirmed diagnosis of colorectal cancer.\n* Confirmation of non-MSI-H\u002FpMMR status.\n* Tumor that is measurable as per RECIST v1.1 and biopsy able, defined as lesion\u002Ftumor that can be biopsied without undue risk.\n* Age ≥ 18 years.\n* ECOG performance status 0-2.\n* Due to the potential teratogenic effect of chemotherapy, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for an adequate amount of time following end of treatment based on the SOC indications for the administered regimen (Refer to Pregnancy Assessment Policy MD Anderson Institutional\n\nPolicy # CLN1114). This includes all female participants, between the onset of menses and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for an adequate amount of time following end of treatment based on the SOC indications for the administered regimen.\n  * The participant is willing and able to sign the informed consent in compliance with protocol requirements, including mandatory biopsies.\n\nExclusion Criteria\n\n* Pregnancy.\n* Participants with concurrent or recent (less than 1 year before consent) malignancies that have the potential to interfere with the study safety and\u002For endpoint assessments will be excluded.\n* Participants for whom there is an intent to proceed to curative therapy (i.e., resection) will be excluded.\n* Participants who have undergone treatment with both oxaliplatin and irinotecan in the metastatic setting will be excluded. Treatment with oxaliplatin in the adjuvant setting with relapse within 6 months will be counted as treatment in the metastatic setting for the purpose of this criterium.\n* For participants who have undergone treatment for metastatic disease, participants who have not progressed (clinically or radiographically) on the most recent therapy will be excluded.\n* Concurrent participation in any other interventional trial.",{"count":675,"type":22},100,[677],"EARLY_PHASE1","To find out if certain drug\u002Ftherapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.",[680,28],"Dynamic Tumor Resistance","2026-06-09",{"date":683,"type":43},"2026-06-11",{"date":685,"type":22},"2026-06-10",{"date":687,"type":22},"2029-11-14",{"name":436,"class":161}]