[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07698613":3,"trial-entities:NCT07698613":88,"trial-summary:NCT07698613":93},{"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":22,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":35,"interventions":38,"primary_outcomes":46,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":17,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":76,"overall_officials":85,"references":86,"see_also_links":87},"NCT07698613","BrUOG 438","EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer","BrUOG 438: EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer","NOT_YET_RECRUITING","2033-09","2026-07","2026-07-13","2026-09","Brown University","OTHER",true,"This is an open label phase II study to determine the safety and preliminary efficacy of photoimmunotherapy (PIT) for patients with locally advanced and borderline resectable pancreatic cancer.",null,[19,20,21],"Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection","Pancreatic Cancer Borderline","Pancreatic Cancer Resectable",[23,24,25,26,27,28,29],"ASP-1929","photoimmunotherapy","EGFR targeting antibody","laser-light activable dye IR700","IRDye 700DX","RM-1929","cetuximab sarotalocan","INTERVENTIONAL","TREATMENT",[33,34],"PHASE1","PHASE2",{"count":36,"type":37},30,"ESTIMATED",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"COMBINATION_PRODUCT","ASP-1929 photoimmunotherapy","Approximately 24 hours prior to surgery, patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic. ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700 (IRDye 700DX). The following day patients will undergo standard surgical exploration. Those patients found to be inoperable on surgical exploration will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy. Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system.",[44],"ASP-1929 PIT",[28,44,29],[47,51],{"measure":48,"description":49,"timeFrame":50},"Incidence of treatment related toxicities grade ≥3","Part 1 \\| Safert: The primary endpoint is grade 3 or higher ASP-1929 photoimmunotherapy treatment related toxicity within 28 days of surgery.","From start of treatment to 28 days post surgery",{"measure":52,"description":53,"timeFrame":54},"Number of Participants Reaching 6 Months Progression Free Survival","Part 2 (expansion cohort for efficacy): The primary endpoint of this cohort is 6-month progression free survival. RECIST version 1.1 will be used to assess for response\u002Fprogression","From start of treatment to 6 months post surgery.",[],"ALL","18 Years",false,{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"Inclusion Criteria:\n\n1. Pathologically confirmed pancreatic adenocarcinoma.\n2. Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma.\n3. Completed neoadjuvant chemotherapy\n4. Neoadjuvant radiation is allowed\n5. Planned surgical exploration\n6. Treatment with ASP-1929 will be at least 4 - 10 weeks after last chemotherapy and radiation.\n7. Patients with a history of biliary obstruction must have adequate biliary drainage.\n8. Patients meeting the following laboratory criteria for Adequate Organ and Bone Marrow Function:\n\n   Platelet Count ≥ 75,000\u002Fmm3. Hemoglobin ≥ 8.0 g\u002FdL \\[NOTE: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g\u002FdL are not eligible\\] Absolute neutrophil count ≥ 1,000\u002Fmm3. \\[Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1\\] Alanine aminotransferase (ALT) ≤ 3×ULN Aspartate aminotransferase (AST) ≤ 3×ULN Total Bilirubin ≤ 1.5×ULN or \\\u003C 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) Creatinine ≤ 3×ULN\n9. Age ≥ 18\n10. ECOG performance status 0-1\n11. For women of pregnancy potential, a negative pregnancy test within 7 days prior to registration.\n12. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients with distant metastases.\n2. Patients with medical co-morbidities that make them not candidates for surgical exploration\n3. Planned concomitant, non-protocol directed anti-cancer therapy for at least 8 weeks after ASP-1929\n4. Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2.\n5. History of significant (Grade ≥ 3) cetuximab infusion reactions\n6. Photosensitizing medications must be discontinued 4 weeks before ASP-1929 PIT treatment, unless medically required.\n7. No uncontrolled intercurrent illness including but not limited to symptomatic CHF, unstable angina, clinically significant severe cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements.\n8. Any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive ASP-1929 and\u002For be exposed to PIT illumination.\n9. Women who are pregnant or nursing.\n10. Patients with concomitant malignancies not expected to cause death within 5 years are eligible.",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Rhode Island and the Miriam Hospitals (Brown University Health)","Providence","Rhode Island","02903\u002F02906","United States",{"lat":74,"lon":75},41.82399,-71.41283,[77,82],{"name":78,"role":79,"phone":80,"email":81},"Roxanne Wood, MPH","CONTACT","401-863-3000","roxanne_wood@brown.edu",{"name":83,"role":79,"email":84},"BrUOG","BrUOG@brown.edu",[],[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Pancreatic Carcinoma",[92],"Soluble Epidermal Growth Factor Receptor",{"nct_id":4,"found":15,"summary":94,"prompt_version":104},{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an open-label Phase II study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 30 participants.","completed","Photoimmunotherapy for Locally Advanced Pancreatic Cancer","This study is testing a new treatment called ASP-1929 photoimmunotherapy for people with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery. This treatment combines an antibody (a protein that targets specific cells) with a special dye. About 24 hours before planned surgery, you would receive ASP-1929 through an IV. The study aims to see how safe ASP-1929 is (looking at side effects) and how well it prevents the cancer from growing for at least six months. This is an early-stage study, and it's currently unclear if it's recruiting new participants.","Your health will be monitored for treatment-related side effects for up to 28 days after surgery, and for cancer progression for at least 6 months after surgery.",94,"You would receive ASP-1929 intravenously (IV) about 24 hours before a planned surgical exploration. This treatment will be given 4 to 10 weeks after your last chemotherapy and radiation.","Not stated in the trial record.",[41],"v2"]