[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dan Feng\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100614263","phase-1-neoadjuvant-dupilumab-and-toripalimab-in-mss-crc-subjects-with-resectable-liver-metastases-100614263",false,"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.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.",[27,28],"Metastatic Colorectal Cancer","Liver Metastases",[30,31,32,33,34,35],"Colorectal cancer","Liver metastases","Neoadjuvant immunotherapy","Dupilumab","Toripalimab","microsatellite stable","NOT_YET_RECRUITING","2026-04-23",{"date":39,"type":40},"2026-04-29","ACTUAL",{"date":42,"type":20},"2026-06-01",{"date":44,"type":20},"2030-12-31",{"name":46,"class":47},"Dan Feng","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100614601","phase-1-combination-immunotherapy-for-the-treatment-of-chemotherapy-refractory-metastatic-mss-crc-100614601","NCT07281716","Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC","A Phase 1b\u002F2 Study of Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC)","Inclusion Criteria:\n\n* Patients must have a pathologically confirmed diagnosis of non-MSI-H\u002FpMMR CRC.\n* Patients must have progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and irinotecan, or are intolerant to standard chemotherapy. Patients may have received, if eligible, anti-VEGF or anti-EGFR antibodies in combination with chemotherapy.\n* Patients must have at least 1 measurable target lesion at baseline ≥ 10mm in the longest diameter.\n* Patient must be willing and able to provide blood samples (6 heparinized, and two streck tubes, roughly 70 - 80 mL) at the time points indicated in the Study Calendar.\n* Patients must have at least 1 lesion suitable for core needle biopsies.\n* Patients must be willing and able to have core needle biopsies, if clinically feasible (Goal 3-6 biopsies, final number to be determined by the interventionalist performing the procedure as safe), of tumor prior to initiation of study drug. Should patients undergo pre-treatment or on-treatment biopsy procedure and inadequate number of biopsies are obtained, they may proceed with initiation\u002Fcontinuation of treatment at the discretion of the investigator and treating physician.\n* Age ≥ 18 years.\n* ECOG Performance Status 0-1 (Karnofsky ≥60%, see https:\u002F\u002Fecog-acrin.org\u002Fresources\u002Fecog-performance-status\u002F). o Patients 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* Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months following completion of therapy. Should a study participant become pregnant or suspect pregnancy while participating in this study, the study participant should inform the treating physician immediately. 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: o Has not undergone a hysterectomy or bilateral oophorectomy; or o Has not been naturally postmenopausal for at least 12 consecutive months\n* Ability to understand and the willingness to sign a written informed consent. • Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy within 14 days from start of therapy.\n* Palliative radiotherapy is permitted at anytime, if deemed in the best interest of the patient.\n* Patients may not be receiving any other investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) 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.\n* Patients who have undergone major surgery within 4 weeks prior to the first dose of treatment.\n* Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n* Patients who discontinued prior immune checkpoint inhibitors due to immune-related adverse events are not eligible for enrollment.\n* Has a 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. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.\n* Has 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). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n* HIV 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* Has known active Hepatitis B (e.g., HBV detected by PCR or active Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n* History of allogeneic hematopoietic cell transplantation or solid organ transplantation.\n* Receipt of a live vaccine within 28 days of planned start of study medication.\n* Receipt of etanercept or other TNF-α inhibitors within 28 days of planned start of the study medication.\n* Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps).\n* Principal investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.\n* History of irAE in response to prior immunotherapy that has not improved to a Grade 0 or 1; this does not include chronic conditions such as endocrinopathies which can be treated with hormone replacement therapy.\n* History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis attributed to prior use of cancer immunotherapy that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted.",{"count":19,"type":20},[23,24],"Phase 1b\u002F2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Phase 1b will assess dose-limiting toxicity (DLT), while Phase 2 will evaluate objective response rate (ORR), including progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Exploratory analyses will investigate immunomodulatory effects through tumor and peripheral blood studies, and treatment will continue every 3 weeks for up to 1 year or until disease progression.",[60],"Metastatic Microsatellite Stable Colorectal Carcinoma",[62,63,64,65,66],"Colorectal Cancer(CRC)","Chemotherapy-refractory colorectal cancer","Microsatellite stable colorectal cancer (MSS CRC)","Metastatic colorectal cancer","Chemotherapy-resistant CRC","RECRUITING","2026-02-17",{"date":70,"type":40},"2026-02-19",{"date":72,"type":40},"2025-12-01",{"date":74,"type":20},"2028-12-15",{"name":46,"class":47},""]