[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pyxis Oncology, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100494587","phase-1-a-study-of-pyx-201-in-advanced-solid-tumors-100494587",false,"NCT05720117","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","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.","ALL","18 Years",{"count":19,"type":20},330,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.",[26,27],"Solid Tumor","Advanced Solid Tumor",[29,30],"Recurrent\u002FMetastatic Solid Tumor","PYX-201","RECRUITING","2026-06-26",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2023-03-14",{"date":39,"type":20},"2028-06-30",{"name":41,"class":42},"Pyxis Oncology, Inc","INDUSTRY",29,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100577216","phase-1-phase-12-study-of-pyx-201-in-combination-with-pembrolizumab-in-advanced-solid-tumors-100577216","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.",{"count":52,"type":20},220,[23,54],"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.",[57],"Advanced Solid Tumors",[57,30,59],"Pembrolizumab","2026-04-28",{"date":62,"type":35},"2026-05-04",{"date":64,"type":35},"2025-04-15",{"date":66,"type":20},"2027-12-06",{"name":41,"class":42},19,""]