[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503705":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":50,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":19,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":19,"enrollmentInfo":64,"targetDuration":19,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Coordination Pharmaceuticals, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RiMO-301","EXPERIMENTAL","Intratumoral injection of RiMO-301 followed by pembrolizumab or nivolumab followed by hypofractionated radiation",[13],"Drug: RiMO-301",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","A single dose of RiMO-301 will be administered via an intratumoral injection.\n\nPD-1 inhibitor (pembrolizumab or nivolumab) will be administered via a 30-minute intravenous infusion until disease progression or unacceptable toxicity.\n\nPatients will receive hypofractionated radiation in 5 fractions.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Lawrence Feldman, MD","University of Illinois at Chicago","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Ze-Qi Xu","CONTACT","630-415-5601","zq@coordinationpharma.com",[32],{"facility":23,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Chicago","Illinois","60612","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-87.65005,41.85003,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":19,"email":49},"Michelle Karan","312-996-9913","makaran2@uic.edu",{"type":51,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[53],{"name":23,"class":54},"OTHER","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":65,"type":66},16,"ESTIMATED","INTERVENTIONAL",[69,70],"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.",[73,74],"Head Neck Cancer","Intratumoral Injection","2025-09-11",{"date":77,"type":78},"2025-09-17","ACTUAL",{"date":80,"type":78},"2023-04-03",{"date":82,"type":66},"2026-12",{"name":5,"class":6},1]