[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573841":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":20,"centralContacts":24,"locations":7,"responsibleParty":30,"collaborators":7,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":7,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":7,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":40,"phases":7,"briefSummary":41,"conditions":42,"keywords":51,"overallStatus":59,"whyStopped":7,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":64,"locationsCount":7},{"fullName":5,"class":6},"Agenus Inc.","INDUSTRY",null,[9,15],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","Botensilimab","Administered via an intravenous (IV) infusion of Botensilimab + Balstilimab combination (BOT+BAL).",[14],"AGEN 1181",{"type":10,"name":16,"description":17,"armGroupLabels":7,"otherNames":18},"Balstililmab","Administered via an IV infusion of Botensilimab + Balstilimab combination (BOT+BAL).",[19],"AGEN 2034",[21],{"name":22,"affiliation":5,"role":23},"Medical Director","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":7,"email":29},"Requests for expanded access use must be initiated by a treating physician. Physicians should contact:","CONTACT","+1-781-202-1614","med.info@agenusbio.com",{"type":31,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100573841","expanded-access-program-eap-designed-to-provide-access-to-botensilimab-and-balstilimab-before-regulatory-approval-100573841",false,"NCT06751524","Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval","Botensilimab and Balstilimab Expanded Access Program","Key Inclusion Criteria:\n\n* The patient's disease is serious or life-threatening.\n* The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contra-indicated.\n* Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment.\n* Sufficient clinical data are available to identify an appropriate dose and treatment duration.\n* The patient's treating physician and qualified medical personnel at Agenus agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks.\n* The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including lack of access due to geographic limitations.\n* Expanded Access will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.\n* The request must be made by the patient's treating physician.\n\nNote: Other defined Inclusion\u002FExclusion criteria may apply.","ALL","EXPANDED_ACCESS","This is an expanded access program (EAP) designed to provide access to Botensilimab and Balstilimab prior to drug registration by the applicable local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[43,44,45,46,47,48,49,50],"Colorectal Cancer (CRC)","Pancreatic Cancer","Non-Small Cell Lung Cancer (NSCLC)","Hepatocellular Carcinoma (HCC)","Melanoma","Sarcoma","Ovarian Cancer","Prostate Cancer",[52,53,54,55,56,57,58],"Compassionate Use","Early Access","Expanded Access","Managed Access","Pre-approval Access","Special Access","Named Patient Program (NPP)","AVAILABLE","2026-05-13",{"date":62,"type":63},"2026-05-15","ACTUAL",{"name":5,"class":6}]