[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577216":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":38,"responsibleParty":213,"collaborators":215,"id":218,"slug":219,"hasResults":220,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":25,"eligibilityCriteria":224,"healthyVolunteers":220,"sex":225,"minAge":226,"maxAge":25,"enrollmentInfo":227,"targetDuration":25,"studyType":230,"phases":231,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},{"fullName":5,"class":6},"Pyxis Oncology, Inc","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Dose Escalation","EXPERIMENTAL","Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab.",[13,14],"Drug: PYX-201","Drug: pembrolizumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 2: Dose Expansion","Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","PYX-201","Intravenous (IV) infusion.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"pembrolizumab","IV infusion.",[9,16],[31],"KEYTRUDA®",[33],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Pyxis Oncology Clinical Trial Team","CONTACT","617-453-3596","clinicaltrials@pyxisoncology.com",[39,53,62,72,82,92,98,108,117,127,133,143,154,163,172,183,192,198,204],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":25},"University of California San Diego","RECRUITING","San Diego","California","92093","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-117.16472,32.71571,{"lat":51,"lon":50},{"facility":54,"status":41,"city":55,"state":43,"zip":56,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":25},"Sarcoma Oncology Center","Santa Monica","90403",{"type":48,"coordinates":58},[59,60],-118.49138,34.01949,{"lat":60,"lon":59},{"facility":63,"status":41,"city":64,"state":65,"zip":66,"country":45,"countryCode":46,"cosmosGeoPoint":67,"geoPoint":71,"contacts":25},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":48,"coordinates":68},[69,70],-82.45843,27.94752,{"lat":70,"lon":69},{"facility":73,"status":41,"city":74,"state":75,"zip":76,"country":45,"countryCode":46,"cosmosGeoPoint":77,"geoPoint":81,"contacts":25},"University of Chicago","Chicago","Illinois","60637",{"type":48,"coordinates":78},[79,80],-87.65005,41.85003,{"lat":80,"lon":79},{"facility":83,"status":41,"city":84,"state":85,"zip":86,"country":45,"countryCode":46,"cosmosGeoPoint":87,"geoPoint":91,"contacts":25},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":48,"coordinates":88},[89,90],-71.05977,42.35843,{"lat":90,"lon":89},{"facility":93,"status":41,"city":84,"state":85,"zip":94,"country":45,"countryCode":46,"cosmosGeoPoint":95,"geoPoint":97,"contacts":25},"Dana-Farber Cancer Institute","02215",{"type":48,"coordinates":96},[89,90],{"lat":90,"lon":89},{"facility":99,"status":41,"city":100,"state":101,"zip":102,"country":45,"countryCode":46,"cosmosGeoPoint":103,"geoPoint":107,"contacts":25},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":48,"coordinates":104},[105,106],-75.16362,39.95238,{"lat":106,"lon":105},{"facility":109,"status":41,"city":110,"state":101,"zip":111,"country":45,"countryCode":46,"cosmosGeoPoint":112,"geoPoint":116,"contacts":25},"University of Pittsburgh Medical Center","Pittsburgh","15232",{"type":48,"coordinates":113},[114,115],-79.99589,40.44062,{"lat":115,"lon":114},{"facility":118,"status":41,"city":119,"state":120,"zip":121,"country":45,"countryCode":46,"cosmosGeoPoint":122,"geoPoint":126,"contacts":25},"University of Texas - 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Hospital Universitario Fundación Jiménez Díaz","28040",{"type":48,"coordinates":196},[189,190],{"lat":190,"lon":189},{"facility":199,"status":41,"city":185,"state":25,"zip":200,"country":176,"countryCode":177,"cosmosGeoPoint":201,"geoPoint":203,"contacts":25},"Hospital Universitario 12 de Octubre","28041",{"type":48,"coordinates":202},[189,190],{"lat":190,"lon":189},{"facility":205,"status":41,"city":206,"state":25,"zip":207,"country":176,"countryCode":177,"cosmosGeoPoint":208,"geoPoint":212,"contacts":25},"Hospital Clínico Universitario de Valencia","Valencia","46010",{"type":48,"coordinates":209},[210,211],-0.37966,39.47391,{"lat":211,"lon":210},{"type":214,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[216],{"name":217,"class":6},"Merck Sharp & Dohme LLC","100577216","phase-1-phase-12-study-of-pyx-201-in-combination-with-pembrolizumab-in-advanced-solid-tumors-100577216",false,"NCT06795412","Phase 1\u002F2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors","A Phase 1\u002F2, Open-label, Global, Multicenter, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n1. Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC.\n2. Male or non-pregnant, non-lactating female participants age ≥18 years.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.\n5. Life expectancy of \\>3 months, in the opinion of the Investigator.\n6. Adequate hematologic function.\n7. Adequate hepatic function.\n8. Adequate renal function.\n9. Adequate coagulation profile.\n10. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.\n\nExclusion Criteria\n\n1. Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n2. Have any active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n3. Significant cardiovascular disease within 6 months prior to start of study drug.\n4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.\n5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).\n6. Failure to recover to Baseline severity or National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≤1 from acute non-hematologic toxicity due to previous therapy, prior to Screening.\n7. Participants with Grade \\>1 neuropathy of any grade per CTCAE v5.0 and\u002For receiving treatment for neuropathy at Screening.\n8. History of uncontrolled diabetes mellitus.\n9. Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab.\n10. Participants with a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD.\n11. Prior solid organ or bone marrow progenitor cell transplantation.\n12. Prior high-dose chemotherapy requiring stem cell rescue.\n13. Previously received treatment with a programmed death-1 (PD-1)\u002FL1 inhibitor any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor.\n14. Severe hypersensitivity (Grade ≥3) to pembrolizumab and\u002For any of its excipients and\u002For PYX-201 and\u002For any of its excipients.","ALL","18 Years",{"count":228,"type":229},220,"ESTIMATED","INTERVENTIONAL",[232,233],"PHASE1","PHASE2","The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors.",[236],"Advanced Solid Tumors",[236,22,238],"Pembrolizumab","2026-04-28",{"date":241,"type":242},"2026-05-04","ACTUAL",{"date":244,"type":242},"2025-04-15",{"date":246,"type":229},"2027-12-06",{"name":5,"class":6},19]