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2TL",{"type":74,"coordinates":480},[481,482],-3.18,51.48,{"lat":482,"lon":481},{"type":485,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":497,"type":498},120,"ESTIMATED","INTERVENTIONAL",[501],"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.",[504],"Breast Cancer, Metastatic",[506,507,508,509,510,511,512,513,514,515,516,31,517,518,519,520,521],"metastatic","Her2+","metastatic HER2-positive breast cancer","breast cancer","HER2-positive","Evorpacept","CD47","ERBB2","Enhertu","trastuzumab deruxtecan","ASPEN-09","solid tumors","trastuzumab","ALX148","mBC","ASPEN-Breast","2026-06-04",{"date":524,"type":525},"2026-06-05","ACTUAL",{"date":527,"type":525},"2025-12-10",{"date":529,"type":498},"2028-12",{"name":5,"class":6},44]