[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sairopa B.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":24,"conditions":25,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100505102","phase-1-phase-1-study-evaluating-the-safety-and-pk-of-adu-1805-in-advanced-solid-tumors-100505102",false,"NCT05856981","Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors","An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n* Male or female aged ≥18 years\n* Signed and dated informed consent form\n* Measurable disease according to RECIST (Safety Expansion only)\n* ECOG Performance status of 0 or 1\n* Adequate organ and marrow function\n* Escalation Phase: Histologically and\u002For cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists\n* Expansion Phase: histologically and\u002For cytologically confirmed diagnosis of advanced PD-(L)1-naïve MSS colorectal cancer (CRC), PD-1 relapsed\u002Frefractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients, and that have measurable disease according to RECIST\n\nExclusion Criteria:\n\n* Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)\n* Expansion Phase:\n\n  * \\> 3 lines of prior systemic treatments\n  * MSS colorectal cancer (CRC): liver metastasis present\n* Pregnancy or breast-feeding\n* Prior treatment with or receipt of:\n\n  * biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805\n  * chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C.\n  * anti-SIRPα or anti-CD47-directed therapy\n  * systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805\n  * other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805\n  * vaccine containing live virus within 28 prior to the first dose of ADU-1805\n* Active untreated brain metastases\n* Active infection requiring systemic therapy\n* Impaired cardiac function or clinically significant cardiac disease\n* Current Grade \\>2 toxicity related to prior anti-cancer therapy\n* History of drug-induced severe immune-related adverse reaction\n* Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients\n* Major surgery within defined period\n* Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis\n* Allogenic tissue\u002Fsolid organ transplant\n* Any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study","ALL","18 Years",{"count":19,"type":20},130,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).",[26,27,28,29,30,31,32],"Solid Tumor, Adult","Metastatic Solid Tumor","Refractory Cancer","CRC, Colorectal Cancer","RCC, Clear Cell Adenocarcinoma","NSCLC (Advanced Non-small Cell Lung Cancer)","Endometrial Cancer",[34],"Immunotherapy","RECRUITING","2025-12-09",{"date":38,"type":39},"2025-12-17","ACTUAL",{"date":41,"type":39},"2023-04-03",{"date":43,"type":20},"2027-07",{"name":45,"class":46},"Sairopa B.V.","INDUSTRY",7,""]