[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05720117":3,"trial-entities:NCT05720117":326,"trial-summary:NCT05720117":333},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":53,"sex":100,"minimum_age":101,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":102,"std_ages":106,"locations":109,"central_contacts":317,"overall_officials":323,"references":324,"see_also_links":325},"NCT05720117","PYX-201-101","A Study of PYX-201 in Advanced Solid Tumors","A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors","RECRUITING","2028-06-30","2026-06","2026-06-30","2023-03-14","Pyxis Oncology, Inc","INDUSTRY",false,"The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent\u002Fmetastatic (R\u002FM) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.",null,[19,20],"Solid Tumor","Advanced Solid Tumor",[22,23],"Recurrent\u002FMetastatic Solid Tumor","PYX-201","INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},330,"ESTIMATED",[32],{"type":33,"name":23,"description":34,"armGroupLabels":35},"DRUG","Antibody-Drug Conjugate",[36,37,38,39,40],"Dose Escalation","Dose Expansion Cohort A (HNSCC)","Dose Expansion Cohort B (TNBC)","Dose Expansion Cohort C (HR+ HER2- BC)","Dose Expansion Cohort D (Other Solid Tumor Types)",[42,46,50],{"measure":43,"description":44,"timeFrame":45},"Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation","DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.","Day 1 to Day 21",{"measure":47,"description":48,"timeFrame":49},"Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Escalation","Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.","Up to approximately 3 years",{"measure":51,"timeFrame":52},"Objective Response Rate (ORR) observed in participants in Dose Expansion","Up to approximately 2 years",[54,58,60,62,64,66,68,70,72,74,76,78,80,82,84,86,89,91,93,95,97],{"measure":55,"description":56,"timeFrame":57},"Maximum Observed Concentration (Cmax) of PYX-201 in Dose Escalation and Dose Expansion","Pharmacokinetic (PK) assessments for PYX-201","Day 1 up to approximately 2 years",{"measure":59,"description":56,"timeFrame":57},"Time to Maximum Concentration (Tmax) of PYX-201 in Dose Escalation and Dose Expansion",{"measure":61,"description":56,"timeFrame":57},"Clearance (CL) of PYX-201 in Dose Escalation",{"measure":63,"description":56,"timeFrame":57},"Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 in Dose Escalation",{"measure":65,"description":56,"timeFrame":57},"Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 in Dose Escalation",{"measure":67,"description":56,"timeFrame":57},"Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 in Dose Escalation",{"measure":69,"description":56,"timeFrame":57},"Half-life (t½) of PYX-201 in Dose Escalation",{"measure":71,"timeFrame":49},"Objective Response Rate (ORR) observed in participants in Dose Escalation",{"measure":73,"timeFrame":49},"Duration of Response (DOR) observed in participants in Dose Escalation and Dose Expansion",{"measure":75,"timeFrame":49},"Progression-free Survival (PFS) observed in participants in Dose Escalation",{"measure":77,"timeFrame":49},"Disease Control Rate (DCR) observed in participants in Dose Escalation and Dose Expansion",{"measure":79,"timeFrame":49},"Time to Response (TTR) observed in participants in Dose Escalation and Dose Expansion",{"measure":81,"timeFrame":49},"Overall Survival (OS) observed in participants in Dose Escalation",{"measure":83,"timeFrame":52},"Incidence of Anti-drug Antibodies (ADA) in participants treated with PYX-201 in Dose Escalation and Dose Expansion",{"measure":85,"timeFrame":52},"Clinical Benefit Rate (CBR) observed in participants in Dose Expansion",{"measure":87,"timeFrame":88},"Median Progression-free Survival (mPFS) observed in participants in Dose Expansion","Up to approximately 4 years",{"measure":90,"timeFrame":88},"Median Overall Survival (mOS) observed in participants in Dose Expansion",{"measure":92,"description":56,"timeFrame":52},"Cmax of PYX-201 in Dose Expansion",{"measure":94,"description":56,"timeFrame":52},"Tmax of PYX-201 in Dose Expansion",{"measure":96,"description":56,"timeFrame":52},"Trough Concentration of PYX-201 in Dose Expansion",{"measure":98,"description":99,"timeFrame":52},"Safety and Tolerability as assessed by adverse event monitoring for participants in Dose Expansion","Adverse Events characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and ECG parameters will be recorded as AEs.","ALL","18 Years",{"inclusion":103,"exclusion":104,"raw_text":105},[],[],"Inclusion\n\n1. Histologically or cytologically confirmed solid tumors including locally advanced\u002Fmetastatic HR+ and HER2- breast cancer (post CDK4\u002F6 inhibitor +\u002F- ET, ≤ 2 lines systemic therapy), TNBC (1-3 prior lines including post ADC topo-1 payload), HNSCC (1-2 prior lines including post PD-L1\u002FPD1 and platinum based therapy), and other solid tumor types (≤ 2 lines systemic therapy).\n2. Male or non-pregnant, non-lactating female participants age ≥18 years.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.\n4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n5. Life expectancy of \\>3 months, in the opinion of the Investigator.\n6. Corrected QTcF \\\u003C470 msec.\n7. Adequate hematologic function.\n8. Adequate hepatic function.\n9. Adequate renal function.\n10. Adequate coagulation profile.\n11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.\n\nExclusion\n\n1. History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer.\n2. Known symptomatic brain metastases.\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 Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.\n7. Participants with NCI-CTCAE v5.0 Grade \\>1 neuropathy of any etiology.\n8. Prior solid organ or bone marrow progenitor cell transplantation.\n9. Prior high-dose chemotherapy requiring stem cell rescue.\n10. Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.\n11. Palliative radiation therapy within 14 days prior to the start of study drug.\n12. Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.\n13. History of uncontrolled diabetes mellitus.\n14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.\n15. Participants with corneal epithelial disease, with the exception of mild punctate keratopathy\n16. Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20\u002F100 (Snellen equivalent).\n17. Participants with a history of (noninfectious) pneumonitis\u002F interstitial lung disease that required steroids, has current pneumonitis\u002F interstitial lung disease, or evidence of active pneumonitis on screening chest CT scan or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.",[107,108],"ADULT","OLDER_ADULT",[110,119,127,135,143,151,159,167,171,179,186,194,202,210,218,225,232,240,249,253,260,268,276,283,287,291,299,308,312],{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":115,"geoPoint":116},"HonorHealth Research Institute","Scottsdale","Arizona","85258","United States",{"lat":117,"lon":118},33.50921,-111.89903,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":115,"geoPoint":124},"Ronald Reagan UCLA Medical Center","Los Angeles","California","90095",{"lat":125,"lon":126},34.05223,-118.24368,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":115,"geoPoint":132},"SCRI - HealthOne Denver","Denver","Colorado","80218",{"lat":133,"lon":134},39.73915,-104.9847,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":115,"geoPoint":140},"SCRI - Florida Cancer Specialists","Sarasota","Florida","34232",{"lat":141,"lon":142},27.33643,-82.53065,{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":115,"geoPoint":148},"Winship Cancer Institute, Emory University","Atlanta","Georgia","30308",{"lat":149,"lon":150},33.749,-84.38798,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":115,"geoPoint":156},"University of Chicago Medicine","Chicago","Illinois","60637",{"lat":157,"lon":158},41.85003,-87.65005,{"facility":160,"status":8,"city":161,"state":162,"zip":163,"country":115,"geoPoint":164},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":165,"lon":166},42.35843,-71.05977,{"facility":168,"status":8,"city":161,"state":162,"zip":169,"country":115,"geoPoint":170},"Dana-Farber Cancer Institute","02215",{"lat":165,"lon":166},{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":115,"geoPoint":176},"Washington University School of Medicine","St Louis","Missouri","63110-1010",{"lat":177,"lon":178},38.62727,-90.19789,{"facility":180,"status":8,"city":181,"state":181,"zip":182,"country":115,"geoPoint":183},"Memorial Sloan Kettering Cancer Center","New York","10065",{"lat":184,"lon":185},40.71427,-74.00597,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":115,"geoPoint":191},"University of Cincinnati Medical Center","Cincinnati","Ohio","45219",{"lat":192,"lon":193},39.12711,-84.51439,{"facility":195,"status":8,"city":196,"state":197,"zip":198,"country":115,"geoPoint":199},"University of Pennsylvania, Abramson Cancer Center","Philadelphia","Pennsylvania","19106",{"lat":200,"lon":201},39.95238,-75.16362,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":115,"geoPoint":207},"Rhode Island Hospital","Providence","Rhode Island","02903",{"lat":208,"lon":209},41.82399,-71.41283,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":115,"geoPoint":215},"NEXT Dallas","Dallas","Texas","75231",{"lat":216,"lon":217},32.78306,-96.80667,{"facility":219,"status":8,"city":220,"state":213,"zip":221,"country":115,"geoPoint":222},"The University of Texas MD Anderson Cancer Center","Houston","77030",{"lat":223,"lon":224},29.76328,-95.36327,{"facility":226,"status":8,"city":227,"state":213,"zip":228,"country":115,"geoPoint":229},"NEXT San Antonio","San Antonio","78229",{"lat":230,"lon":231},29.42412,-98.49363,{"facility":233,"status":8,"city":234,"state":235,"zip":236,"country":115,"geoPoint":237},"NEXT Virginia","Fairfax","Virginia","22031",{"lat":238,"lon":239},38.84622,-77.30637,{"facility":241,"status":8,"city":242,"state":243,"zip":244,"country":245,"geoPoint":246},"Institut Jules Bordet","Brussels","Brussels Capital","1070","Belgium",{"lat":247,"lon":248},50.85045,4.34878,{"facility":250,"status":8,"city":242,"state":243,"zip":251,"country":245,"geoPoint":252},"Cliniques Universitaires Saint-Luc","1200",{"lat":247,"lon":248},{"facility":254,"status":8,"city":255,"state":255,"zip":256,"country":245,"geoPoint":257},"Universitair Ziekenhuis Antwerpen","Edegem","2650",{"lat":258,"lon":259},51.15662,4.44504,{"facility":261,"status":8,"city":262,"state":263,"zip":264,"country":245,"geoPoint":265},"Universitair Ziekenhuis Gent","Ghent","Gent","9000",{"lat":266,"lon":267},51.05,3.71667,{"facility":269,"status":8,"city":270,"state":270,"zip":271,"country":272,"geoPoint":273},"Hospital Universitari Vall d'Hebrón","Barcelona","08035","Spain",{"lat":274,"lon":275},41.38879,2.15899,{"facility":277,"status":8,"city":278,"state":278,"zip":279,"country":272,"geoPoint":280},"START Madrid - Hospital Universitario Fundación Jiménez Díaz","Madrid","28040",{"lat":281,"lon":282},40.4165,-3.70256,{"facility":284,"status":8,"city":278,"state":278,"zip":285,"country":272,"geoPoint":286},"Hospital Universitario 12 de Octubre","28041",{"lat":281,"lon":282},{"facility":288,"status":8,"city":278,"state":278,"zip":289,"country":272,"geoPoint":290},"Hospital Universitario HM Sanchinarro","28050",{"lat":281,"lon":282},{"facility":292,"status":8,"city":293,"state":294,"zip":295,"country":272,"geoPoint":296},"Hospital Clínico Universitario de Valencia","Valencia","València","46010",{"lat":297,"lon":298},39.47391,-0.37966,{"facility":300,"status":8,"city":301,"state":302,"zip":303,"country":304,"geoPoint":305},"University College Hospital","London","England","NW1 2PG","United Kingdom",{"lat":306,"lon":307},51.50853,-0.12574,{"facility":309,"status":8,"city":301,"state":302,"zip":310,"country":304,"geoPoint":311},"The Royal Marsden Hospital","SW3 6JJ",{"lat":306,"lon":307},{"facility":313,"status":314,"city":301,"state":302,"zip":315,"country":304,"geoPoint":316},"Sarah Cannon Research Institute London","ACTIVE_NOT_RECRUITING","W1G 6AD",{"lat":306,"lon":307},[318],{"name":319,"role":320,"phone":321,"email":322},"Pyxis Oncology Clinical Trials Team","CONTACT","(339) 545 8252","clinicaltrials@pyxisoncology.com",[],[],[],{"nct_id":4,"conditions":327,"biomarkers":332},[328,329,330,331],"Breast Carcinoma","Head and Neck Squamous Cell Carcinoma","Solid Neoplasm","Triple-Negative Breast Carcinoma",[],{"nct_id":4,"found":334,"summary":335,"prompt_version":344},true,{"design":336,"status":337,"heading":6,"summary":338,"follow_up":339,"word_count":340,"commitments":341,"compensation":342,"drugs_mentioned":343},"This study is interventional and plans to enroll 330 participants. It is designed to evaluate the safety and effectiveness of PYX-201 as a single agent.","completed","This study is testing a new drug called PYX-201, which is an antibody-drug conjugate (a targeted therapy that delivers a powerful drug directly to cancer cells). It's for adults aged 18 and older with advanced solid tumors, including certain types of breast cancer, head and neck cancer, and other solid tumors that have progressed after previous treatments. The main goals are to find the safest and most effective dose of PYX-201 and to see how many participants respond to the treatment. We don't yet know the current recruitment status for this study.","Participants will be monitored for safety and tolerability for up to approximately 3 years. Objective response to treatment will be measured for up to approximately 2 years.",92,"Participants will be monitored for side effects for up to approximately 3 years. The study will also measure how well the treatment works for up to approximately 2 years.","Not stated in the trial record.",[23],"v2"]