{"commentary":{"count":61,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":28,"youtube":17,"podcast":16},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03505320\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"ILUSTRO","nct_id":"NCT03505320","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ilustro-nct03505320. The price is fixed at order. We build the report after 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: 41+ commentary sources"},"registry":{"acronym":"ILUSTRO","arms":[{"description":"Participants will be treated with zolbetuximab on a 21-day cycle in which zolbetuximab will be administered as a single agent every 3 weeks until disease progression, toxicity requiring cessation, start of another anti-cancer treatment or other treatment discontinuation criteria are met.","label":"zolbetuximab (Cohort 1A)","type":"EXPERIMENTAL"},{"description":"Participants will be treated with zolbetuximab and mFOLFOX6 on a 42-day cycle in which zolbetuximab is administered on days 1 and 22, and mFOLFOX6 is administered on days 1, 15 and 29; however, for the first cycle, zolbetuximab will be administered on day 3 (instead of day 1) to allow for pharmacokinetic collection. Participants will receive up to 12 mFOLFOX6 treatments (4 cycles). Beginning at cycle 5, participants may continue on 5-FU and leucovorin or folinic acid along with zolbetuximab for the remainder of the study per investigator's discretion. mFOLFOX6 treatment includes oxaliplatin: intravenous \\[IV\\] infusion, leucovorin: IV infusion, fluorouracil bolus: IV bolus, fluorouracil infusion: continuous IV infusion.","label":"mFOLFOX6 plus zolbetuximab (Cohort 2)","type":"EXPERIMENTAL"},{"description":"Participants will be treated with zolbetuximab and pembrolizumab on a 21-day cycle. Loading dose of zolbetuximab will be administered at cycle 1, day 1 followed by maintenance dose of zolbetuximab once every 3 weeks (Q3W). Pembrolizumab will be administered to 3 to 6 subjects at a intravenously on day 1 of every 21-day cycle and will be infused 1 hour after the zolbetuximab infusion is completed. Tolerability and safety of zolbetuximab in combination with pembrolizumab will be evaluated during the 3-week dose-limiting toxicity (DLT) assessment period. If this cycle 1 dose is not tolerable, a lower dose of zolbetuximab in combination with pembrolizumab will subsequently be evaluated.","label":"Pembrolizumab plus zolbetuximab (Cohort 3A)","type":"EXPERIMENTAL"},{"description":"Participants will be treated with zolbetuximab and mFOLFOX6, nivolumab on a 42-day cycle. Cohort 4A: Loading dose of zolbetuximab in combination with nivolumab and mFOLFOX6 on cycle 1 day 1, followed by zolbetuximab in combination with nivolumab and mFOLFOX6 q2w \\[days 15 and 29\\] (1 cycle = 6 weeks). Tolerability and safety of zolbetuximab in combination with nivolumab, mFOLFOX6 will be evaluated during the 3-week DLT assessment period. If cycle 1 dose is not tolerable, a lower dose of dose zolbetuximab in combination with nivolumab and mFOLFOX6 will be subsequently evaluated. Cohort 4B: Subjects will be treated with the combination of zolbetuximab, mFOLFOX6 and nivolumab at the dose deemed tolerable in Cohort 4A. Subjects will receive up to 12 mFOLFOX6 treatments (4 cycles). For Cohorts 4A and 4B, beginning at cycle 5, subjects may continue on 5-FU and leucovorin or folinic acid along with zolbetuximab and nivolumab for the remainder of the study per investigator's discretion.","label":"Zolbetuximab in combination with mFOLFOX6 and nivolumab (Cohort 4A/4B)","type":"EXPERIMENTAL"},{"description":"Participants will be treated with zolbetuximab \\& FLOT for a total of eight 2-week cycles. 4 cycles preoperatively \\& 4 cycles postoperatively 6-12 weeks after surgery.\n\nPreoperative: Participants will receive zolbetuximab loading dose on cycle 1 day 1, followed by FLOT on cycle 1 day 2. For cycles 2-4, participants may receive zolbetuximab maintenance dose in combination with FLOT, dosed on day 1 of each cycle. However, dosing may be split over 2 days with zolbetuximab administration on day 1 \\& FLOT on day 2.\n\nPost operative: Participants will receive zolbetuximab loading dose on cycle 5 day 1, followed by FLOT on cycle 5 day 2. For cycles 6-8, participants may receive zolbetuximab maintenance dose in combination with FLOT, dosed on day 1 of each cycle. However, dosing may be split over 2 days with zolbetuximab administration on day 1 and FLOT on day 2. For participants who experience a DLT during preoperative treatment on the loading dose, the postoperative loading dose may be lowered.","label":"Zolbetuximab in combination with FLOT (Cohort 5)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-05-31","type":"ESTIMATED"},"conditions":["Pharmacokinetics of Zolbetuximab","Gastric Cancer","Gastro-esophageal Junction (GEJ) Cancer","Pharmacokinetics of Oxaliplatin","Pharmacokinetics of Fluorouracil Bolus (5-FU)"],"enrollment":{"count":143,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"zolbetuximab","type":"DRUG"},{"name":"oxaliplatin","type":"DRUG"},{"name":"leucovorin","type":"DRUG"},{"name":"fluorouracil","type":"DRUG"},{"name":"Pembrolizumab","type":"DRUG"},{"name":"folinic acid","type":"DRUG"},{"name":"nivolumab","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"}],"last_update":"2026-08-31","lead_sponsor":"Astellas Pharma Global Development, Inc.","official_title":"A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination With Chemotherapy and/or Immunotherapy in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose Are Claudin (CLDN) 18.2 Positive","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-06-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR) of zolbetuximab as a single agent by central review (Cohort 1)","timeFrame":"Up to 3 months"}],"references":[{"citation":"Shitara K, Shoji H, Fazio N, Lonardi S, Lee KW, Bai LY, Yamaguchi K, Metges JP, Masi G, Smith D, Kim TY, Matsangou M, Shrivastava A, Zhou M, Hill J, Guerrero A, Wang X, Zaanan A, Klempner SJ. First-line zolbetuximab plus mFOLFOX6 and nivolumab in unresectable CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. Nat Med. 2026 Jun;32(6):2182-2190. doi: 10.1038/s41591-026-04306-9. Epub 2026 Mar 16.","pmid":"41840238","type":"DERIVED"},{"citation":"Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.","pmid":"40341124","type":"DERIVED"}],"start_date":{"date":"2018-06-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer","url":"https://clinicaltrials.gov/study/NCT03505320"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ilustro-nct03505320"}