{"preliminary_commentary":{"by_channel":{"x_thread":17,"youtube":4,"podcast":2,"bluesky_thread":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\": \"NCT03816163\", \"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,"name":"GLEAM","nct_id":"NCT03816163","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gleam-nct03816163. 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":"Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.","label":"zolbetuximab +nab-paclitaxel + gemcitabine","type":"EXPERIMENTAL"},{"description":"Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.","label":"nab-paclitaxel + gemcitabine","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-10-31","type":"ESTIMATED"},"conditions":["Pancreatic Cancer","Metastatic Pancreatic Cancer","Metastatic Pancreatic Adenocarcinoma"],"enrollment":{"count":393,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"zolbetuximab","otherNames":["IMAB362"],"type":"DRUG"},{"name":"nab-paclitaxel","otherNames":[],"type":"DRUG"},{"name":"gemcitabine","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-14","lead_sponsor":"Astellas Pharma Global Development, Inc.","official_title":"A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-10-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Dose Limiting Toxicities (DLT) - (safety lead in)","timeFrame":"Up to 28 days"},{"measure":"Overall Survival (OS)","timeFrame":"Up to 79 months"},{"measure":"Safety assessed by Adverse Events (AEs)","timeFrame":"From signing inform consent form until 90 days after the last dose of the study drug (Up to 82 months)"},{"measure":"Safety assessed by incidence of serious adverse events (SAE)","timeFrame":"From signing inform consent form until 90 days after the last dose of the study drug (Up to 82 months)"},{"measure":"Safety assessed by incidence of treatment emergent adverse events (TEAE)","timeFrame":"From first dose up to 30 days after last dose (Up to 80 months)"},{"measure":"Number of participants with laboratory value abnormalities and/or adverse events (AEs)","timeFrame":"From first dose up to 30 days after last dose (Up to 80 months)"},{"measure":"Number of participants with vital sign abnormalities and /or adverse events (AEs)","timeFrame":"From first dose up to 30 days after last dose (Up to 80 months)"},{"measure":"Number of participants with electrocardiograms (ECG) abnormalities and or adverse events","timeFrame":"From first dose up to 30 days after last dose (Up to 80 months)"},{"measure":"Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events","timeFrame":"From first dose up to 30 days after last dose (Up to 80 months)"}],"references":[],"start_date":{"date":"2019-03-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer","url":"https://clinicaltrials.gov/study/NCT03816163"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/gleam-nct03816163"}