{"preliminary_commentary":{"by_channel":{"x_thread":22,"podcast":4,"youtube":1,"x_video":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02795988\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["IMU-131"]],"indication":"HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma","name":"HERIZON","nct_id":"NCT02795988","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=herizon-nct02795988. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"10, 30, 50μg IMU-131 plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine","label":"Phase 1b","type":"EXPERIMENTAL"},{"description":"50 μg IMU-131 plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and Capecitabine.","label":"Phase 2 - IMU 131 plus chemotherapy","type":"EXPERIMENTAL"},{"description":"Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and Capecitabine.","label":"Phase 2 - Chemotherapy only","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-03-20","type":"ACTUAL"},"conditions":["Gastrointestinal Neoplasms","Adenocarcinoma"],"enrollment":{"count":64,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"IMU-131","otherNames":["HER-Vaxx"],"type":"BIOLOGICAL"},{"name":"Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.","otherNames":["Standard of Care Chemotherapy"],"type":"DRUG"}],"last_update":"2025-04-16","lead_sponsor":"Imugene Limited","official_title":"A Phase 1b/2 Open-Label Study With Randomization in Phase 2 of IMU-131 HER2/Neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients With HER2/Neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2024-03-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 1b: Number of Participants With Adverse Events (AEs)","timeFrame":"Up to approximately 7 months"},{"measure":"Phase 2: Overall Survival (OS)","timeFrame":"Up to approximately 30 months"},{"measure":"Phase 2 Extension: Number of Participants With AEs","timeFrame":"From date of first dose to date of last dose plus 30 days (Up to 24 months)"}],"references":[{"citation":"Tobias J, Maglakelidze M, Andric Z, Ryspayeva D, Bulat I, Nikolic I, Petrovic Z, Chawla T, Nagarkar R, Garner-Spitzer E, Zielinski CC, Chong LMO, Nixon B, Ede NJ, Yavrom S, Kundi M, Wiedermann U. Phase II Trial of HER-Vaxx, a B-cell Peptide-Based Vaccine, in HER2-Overexpressing Advanced Gastric Cancer Patients Under Platinum-Based Chemotherapy (HERIZON). Clin Cancer Res. 2024 Sep 13;30(18):4044-4054. doi: 10.1158/1078-0432.CCR-24-0742.","pmid":"39028916","type":"DERIVED"},{"citation":"Wiedermann U, Garner-Spitzer E, Chao Y, Maglakelidze M, Bulat I, Dechaphunkul A, Arpornwirat W, Charoentum C, Yen CJ, Yau TC, Tanasanvimon S, Maneechavakajorn J, Sookprasert A, Bai LY, Chou WC, Ungtrakul T, Drinic M, Tobias J, Zielinski CC, Chong L, Ede NJ, Marino MT, Good AJ. Clinical and Immunologic Responses to a B-Cell Epitope Vaccine in Patients with HER2/neu-Overexpressing Advanced Gastric Cancer-Results from Phase Ib Trial IMU.ACS.001. Clin Cancer Res. 2021 Jul 1;27(13):3649-3660. doi: 10.1158/1078-0432.CCR-20-3742. Epub 2021 Apr 20.","pmid":"33879458","type":"DERIVED"}],"start_date":{"date":"2017-08-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer","url":"https://clinicaltrials.gov/study/NCT02795988"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/herizon-nct02795988"}