[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599484":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":34,"locations":40,"responsibleParty":124,"collaborators":28,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":28,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":28,"enrollmentInfo":135,"targetDuration":28,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":150,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"ALX Oncology Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ALX2004 Phase 1a (Dose Escalation)","EXPERIMENTAL","ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase",[13],"Drug: ALX2004",{"label":15,"type":10,"description":16,"interventionNames":17},"ALX2004 Phase 1a (Dose Exploration)","ALX2004 will be administered. All or a subset of tumors tested in dose escalation will enroll into 1 or 2 dose levels during the dose exploration phase",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"ALX2004 Phase 1b (Dose Expansion)","ALX2004 will be administered. Patients will receive the recommended phase 2 dose during the dose expansion phase",[13],[23,29,32],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","ALX2004","ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion",[9],null,{"type":24,"name":25,"description":30,"armGroupLabels":31,"otherNames":28},"ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion",[15],{"type":24,"name":25,"description":30,"armGroupLabels":33,"otherNames":28},[19],[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Athanasios Tsiatis, MD","CONTACT","650-466-7125","info@alxoncology.com",[41,55,65,74,84,94,104,114],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":28},"ALX Center 7","RECRUITING","Tampa","Florida","33612","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-82.45843,27.94752,{"lat":53,"lon":52},{"facility":56,"status":43,"city":57,"state":58,"zip":59,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":28},"ALX Center 8","Farmington Hills","Michigan","48334",{"type":50,"coordinates":61},[62,63],-83.37716,42.48531,{"lat":63,"lon":62},{"facility":66,"status":43,"city":67,"state":58,"zip":68,"country":47,"countryCode":48,"cosmosGeoPoint":69,"geoPoint":73,"contacts":28},"ALX Center 3","Grand Rapids","49546",{"type":50,"coordinates":70},[71,72],-85.66809,42.96336,{"lat":72,"lon":71},{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":28},"ALX Center 6","Portland","Oregon","97213",{"type":50,"coordinates":80},[81,82],-122.67621,45.52345,{"lat":82,"lon":81},{"facility":85,"status":43,"city":86,"state":87,"zip":88,"country":47,"countryCode":48,"cosmosGeoPoint":89,"geoPoint":93,"contacts":28},"ALX Center 5","Houston","Texas","77030",{"type":50,"coordinates":90},[91,92],-95.36327,29.76328,{"lat":92,"lon":91},{"facility":95,"status":43,"city":96,"state":97,"zip":98,"country":47,"countryCode":48,"cosmosGeoPoint":99,"geoPoint":103,"contacts":28},"ALX Center 4","West Valley City","Utah","84119",{"type":50,"coordinates":100},[101,102],-112.00105,40.69161,{"lat":102,"lon":101},{"facility":105,"status":43,"city":106,"state":107,"zip":108,"country":47,"countryCode":48,"cosmosGeoPoint":109,"geoPoint":113,"contacts":28},"ALX Center 2","Fairfax","Virginia","22031",{"type":50,"coordinates":110},[111,112],-77.30637,38.84622,{"lat":112,"lon":111},{"facility":115,"status":43,"city":116,"state":117,"zip":118,"country":47,"countryCode":48,"cosmosGeoPoint":119,"geoPoint":123,"contacts":28},"ALX Center 1","Spokane","Washington","99208",{"type":50,"coordinates":120},[121,122],-117.42908,47.65966,{"lat":122,"lon":121},{"type":125,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100599484","phase-1-a-first-in-human-study-of-alx2004-with-advanced-or-metastatic-selected-solid-tumors-100599484",false,"NCT07085091","A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors","A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select Solid Tumors","Inclusion Criteria:\n\n* Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent\n\n  1. Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced\u002Fmetastatic setting and for whom no approved or standard therapy is available.\n  2. Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors.\n\nHNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting\n\nNSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced\u002Fmetastatic setting. For participants without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced\u002Fmetastatic setting\n\nESCC - Received no more than 3 prior lines of therapy in the advanced\u002Fmetastatic setting\n\nCRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced\u002Fmetastatic setting. For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced\u002Fmetastatic setting.\n\n* Adequate Bone Marrow Function\n* Adequate Renal \\& Liver Function\n* Adequate Performance Status\n\nExclusion Criteria:\n\n* Participants with disease suitable for local therapy with curative intent.\n* Has a life expectancy of less than 3 months and\u002For has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator\n* Prior treatment with any ADCs that have an active TOP1 inhibitor-based component","ALL","18 Years",{"count":136,"type":137},170,"ESTIMATED","INTERVENTIONAL",[140],"PHASE1","A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors",[143,144,145,146,147,148,149],"NSCLC (Advanced Non-small Cell Lung Cancer)","HNSCC","CRC (Colorectal Cancer)","ESCC","Colo-rectal Cancer","Head and Neck Cancer","Esophageal Squamous Cell Carcinoma (ESCC)",[25,151,152,153,154,155,144,156,157,158,159,160],"EGFR","Solid Tumors","metastatic","Antibody Drug Conjugate","ADC","CRC","Lung","Non small cell lung cancer","esophageal","EGFR ADC","2026-05-11",{"date":163,"type":164},"2026-05-12","ACTUAL",{"date":166,"type":164},"2025-08-18",{"date":168,"type":137},"2027-12",{"name":5,"class":6},8]