[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Coordination Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"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":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100503705","phase-1-study-of-rimo-301-and-radiotherapy-with-pd-1-inhibitor-for-the-treatment-of-head-neck-cancer-100503705",false,"NCT05838729","Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer","Phase 1b\u002F2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer","Inclusion Criteria:\n\n* Diagnosis of head-neck cancer that requires palliative radiotherapy\n* Patients with unresectable, recurrent or metastatic HNSCC, regardless if the patients have progressed on or are intolerant to platinum-based chemotherapy prior to study enrollment or if the patients are receiving pembrolizumab in the first line:\n\n  * receiving a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care, or\n  * suitable to receive a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care in the discretion of the treating physician or Principal Investigator\n* Must have at least 1 target lesion that is clinically accessible to RiMO-301 injection and amenable to receive RT regimens specified in this protocol\n* The selected target lesions must be measurable on cross-sectional imaging and repeated measurements at the same location should be achievable\n* Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection and with no complications from the prior radiation course\n* RiMO-301 injection to multiple lesions (≤ 5 in total) in a single patient is allowed as long as the total tumor volume does not exceed 250 cm3\n* Patient must have recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments prior to enrollment\n* Have adequate bone marrow reserve and adequate liver function\n* Have a life expectancy of at least 12 weeks\n* ECOG score of 0-2\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions\n* Symptomatic central nervous system metastases and\u002For carcinomatous meningitis\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* Ongoing clinically significant infection at or near the incident lesion\n* Major surgery over the target area (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days. No waiting is required following implantable port, enteral feeding tube and catheter placement\n* Has received any approved or investigational anti-neoplastic agent or immunotherapy other than PD-1 inhibitors (pembrolizumab or nivolumab) within 4 weeks prior to RiMO-301 injection\n* Patients with lesions which have significant blood vessel involvement (such as carotid artery encasement) or other major structures","ALL","18 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with hypofractionated radiation and a PD-1 Inhibitor in patients with unresectable, recurrent or metastatic head-neck cancer.",[27,28],"Head Neck Cancer","Intratumoral Injection","RECRUITING","2025-09-11",{"date":32,"type":33},"2025-09-17","ACTUAL",{"date":35,"type":33},"2023-04-03",{"date":37,"type":20},"2026-12",{"name":39,"class":40},"Coordination Pharmaceuticals, Inc.","INDUSTRY",""]