[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ALX Oncology Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100593524","phase-2-aspen-09-03-a-study-of-evorpacept-in-combination-with-trastuzumab-and-chemotherapy-in-metastatic-her2-positive-breast-cancer-100593524",false,"NCT07007559","ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer","Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b\u002F2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced \u002F Metastatic Malignancies","ASPEN-09-03","Inclusion Criteria:\n\n* Histologically confirmed invasive HER2+ breast cancer.\n* Received at least one prior line of therapy including T-DXd (ENHERTU) for locally advanced\u002Fmetastatic HER2+ breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease. Participants who discontinue T-DXd due to intolerance are considered eligible.\n* Progressed on or following the most recent line of therapy.\n* Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine).\n* Measurable disease as defined by RECIST v1.1.\n* LVEF ≥50%.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.\n* Life expectancy of at least 3 months.\n* Adequate renal function (estimated creatinine clearance ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n* Adequate liver function:\n\n  * Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome);\n  * Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).\n* Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible and which do not constitute a safety risk by Investigator judgment.\n\nExclusion Criteria:\n\n* Participants with known CNS metastases unless treated and stable prior to enrollment.\n* Prior exposure to any anti-CD47 or anti-SIRPα agent.\n* Any condition that would be contraindicated to receiving trastuzumab\n* Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen\n* Following anti-cancer therapy with insufficient washout before start of treatment:\n\n  1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of start of treatment.\n  2. Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of start of treatment).\n* History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.\n* Had an allogeneic tissue\u002Fsolid organ transplant.\n* Any active, unstable cardiovascular disease.\n* Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Other primary malignancy within 2 years.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting.\n\nASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows:\n\n* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.\n* Recurrent\u002Fmetastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.",[27],"Breast Cancer, Metastatic",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"metastatic","Her2+","metastatic HER2-positive breast cancer","breast cancer","HER2-positive","Evorpacept","CD47","ERBB2","Enhertu","trastuzumab deruxtecan","ASPEN-09","Herceptin","solid tumors","trastuzumab","ALX148","mBC","ASPEN-Breast","RECRUITING","2026-06-04",{"date":49,"type":50},"2026-06-05","ACTUAL",{"date":52,"type":50},"2025-12-10",{"date":54,"type":21},"2028-12",{"name":56,"class":57},"ALX Oncology Inc.","INDUSTRY",44,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":79,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100599484","phase-1-a-first-in-human-study-of-alx2004-with-advanced-or-metastatic-selected-solid-tumors-100599484","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",{"count":67,"type":21},170,[69],"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",[72,73,74,75,76,77,78],"NSCLC (Advanced Non-small Cell Lung Cancer)","HNSCC","CRC (Colorectal Cancer)","ESCC","Colo-rectal Cancer","Head and Neck Cancer","Esophageal Squamous Cell Carcinoma (ESCC)",[80,81,82,29,83,84,73,85,86,87,88,89],"ALX2004","EGFR","Solid Tumors","Antibody Drug Conjugate","ADC","CRC","Lung","Non small cell lung cancer","esophageal","EGFR ADC","2026-05-11",{"date":92,"type":50},"2026-05-12",{"date":94,"type":50},"2025-08-18",{"date":96,"type":21},"2027-12",{"name":56,"class":57},8,""]