[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635238":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":36,"locations":37,"responsibleParty":56,"collaborators":60,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":36,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":36,"enrollmentInfo":71,"targetDuration":36,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":92,"whyStopped":36,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Scripps Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment arm","EXPERIMENTAL","balstilimab (BAL) + botensilimab (BOT) + agenT-797",[13,14,15],"Drug: Balstilimab (BAL)","Drug: Botensilimab (BOT)","Drug: agenT-797",[17,24,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Balstilimab (BAL)","Administered at a fixed dose of 240mg intravenously (IV) on Days 1, 15, 29 of each 42-day cycle, for up to 9 cycles.",[9],[23],"AGEN2034",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Botensilimab (BOT)","Administered at a fixed dose of 75mg IV on Day 1 of Cycles 1 through 4. In the event of protocol-defined toxicity, the dose may be reduced to 50mg IV per protocol defined criteria.",[9],[29],"AGEN1181",{"type":18,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"agenT-797","Administered at a dose of 1.4 x 107 cells\u002Fkg IV on Day 1 of Cycle 1 and Day 15 of Cycle 2.",[9],[35],"allo-INKTs",null,[38],{"facility":39,"status":36,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Scripps Clinic Torrey Pines","La Jolla","California","92037","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-117.2742,32.84727,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":36,"phoneExt":36,"email":55},"Darren Sigal Principal Investigator, MD","CONTACT","CRSLeadership@scrippshealth.org",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Darren Sigal, MD","Director, GI Oncology Division of Hematology\u002FOncology",[61],{"name":5,"class":6},"100635238","phase-2-balbotagent-797-in-pmmr-crc-with-liver-metastases-100635238",false,"NCT07550088","BAL\u002FBOT\u002FagenT-797 in pMMR CRC With Liver Metastases","A Single-Arm, Phase II Study Evaluating Combination Balstilimab Plus Botensilimab With AgenT-797 in Previously Treated Patients With pMMR Metastatic CRC With Liver Metastases","Inclusion Criteria:\n\n* Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver disease if previously treated locally\n* At least one measurable lesion per RECIST v1.1, with ≥1 target lesion in the liver\n* Tumor confirmed as microsatellite stable (MSS)\u002Fproficient mismatch repair (pMMR)\n* Received ≥1 prior line of systemic therapy including fluorouracil, oxaliplatin, and irinotecan (not necessarily in combination), and prior EGFR inhibitor or bevacizumab if eligible, unless contraindicated\n* ECOG performance status 0-1 and life expectancy ≥12 weeks\n* Adequate organ and marrow function:\n\n  * ANC ≥1.5 × 10⁹\u002FL\n  * Platelets ≥100 × 10⁹\u002FL\n  * Hemoglobin ≥8 g\u002FdL\n  * AST\u002FALT ≤2.5 × ULN\n  * Total bilirubin ≤1.5 × ULN\n  * Creatinine clearance ≥30 mL\u002Fmin\n  * Albumin ≥3 g\u002FdL\n  * PT\u002FPTT ≤1.5 × ULN\n* Willing and able to provide written informed consent\n* Negative pregnancy test for women of childbearing potential\n* Agreement to use effective contraception during study participation\n\nExclusion Criteria:\n\n* Tumor is dMMR\u002FMSI-high\n* Prior treatment with PD-1, PD-L1, CTLA-4 inhibitors, or other immunotherapy agents\n* Evidence of bowel obstruction, impending obstruction, or recent obstruction (within 3 months)\n* Refractory ascites requiring frequent paracentesis or recent escalation of diuretics\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke, unstable angina, NYHA class ≥III heart failure, uncontrolled arrhythmias) or QTc \\>480 ms\n* Active or untreated brain metastases or leptomeningeal disease\n* Concurrent malignancy requiring treatment or active within 2 years (with protocol-specified exceptions)\n* Receipt of prior anti-cancer therapy within protocol-defined washout periods, including:\n\n  * Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.\n  * Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.\n  * Small molecules\u002Ftyrosine kinase inhibitors within 2 weeks or less than 5 circulating half-lives of investigational drug.\n* Known hypersensitivity to study drugs or excipients\n* History of or active interstitial lung disease or pneumonitis requiring systemic steroids\n* Prior allogeneic transplant (organ, stem cell, or bone marrow)\n* Active or recent autoimmune disease requiring systemic treatment\n* Requirement for systemic corticosteroids (\\>10 mg prednisone equivalent) or other immunosuppressive therapy within defined windows\n* Active infection, including HIV, HTLV, HBV, HCV, or other infections requiring systemic therapy\n* Recent SARS-CoV-2 infection within protocol-defined timeframe\n* Uncontrolled hypertension, significant proteinuria (UPCR ≥1 g\u002Fg), or other clinically significant uncontrolled medical conditions\n* Non-healing wounds, active bleeding, or uncontrolled thyroid dysfunction\n* Psychiatric or substance use disorders that may interfere with study participation\n* Receipt of live or attenuated vaccines within 30 days prior to treatment and while participating in the study\n* Pregnant or breastfeeding women, or those planning pregnancy during the study","ALL","18 Years",{"count":72,"type":73},17,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The goal of this clinical trial is to learn whether the combination of balstilimab, botensilimab, and agenT-797 is safe and effective in treating adults with previously treated metastatic colorectal cancer that is microsatellite stable (pMMR) and has spread to the liver.\n\nThe main questions it aims to answer are:\n\n* What proportion of participants experience tumor shrinkage (objective response rate) based on imaging assessments?\n* What side effects occur with this combination treatment, including immune-related and cytokine-related reactions?\n\nAll participants in this study will receive the combination treatment. There is no comparison group.\n\nParticipants will:\n\n* Receive balstilimab, botensilimab, and agenT-797 in repeating 42-day treatment cycles\n* Undergo imaging scans (such as CT or MRI) to assess tumor response\n* Have blood samples collected to monitor safety and evaluate biomarkers\n* Provide tumor tissue samples for research\n* Be monitored for side effects throughout the study\n* Participate in follow-up visits to assess survival after treatment completion",[79],"Colorectal Cancer Metastatic",[81,82,83,84,85,86,87,88,89,90,31,91],"Metastatic Colorectal Cancer","pMMR Colorectal Cancer","Liver Metastases","Immunotherapy","Checkpoint Inhibitor","Anti-PD-1","Anti-CTLA-4","iNKT Cell Therapy","Balstilimab","Botensilimab","MSS Colorectal Cancer","NOT_YET_RECRUITING","2026-04-21",{"date":95,"type":96},"2026-04-24","ACTUAL",{"date":98,"type":73},"2026-06",{"date":100,"type":73},"2028-12",{"name":58,"class":6},1]