{"preliminary_commentary":{"by_channel":{"youtube":31,"x_thread":26,"podcast":24},"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\": \"NCT04606381\", \"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":null,"indication":"advanced solid malignancies","name":"PALOMA","nct_id":"NCT04606381","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=paloma-nct04606381. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"PALOMA","arms":[{"description":"Participants in cohort 1a will receive amivantamab admixed with rHuPH20 (Ami-LC-MD) subcutaneous (SC) infusion and participants in cohort 1b will receive amivantamab (Ami-LC) SC infusion.","label":"Part 1: Ami-LC-MD and Ami-LC","type":"EXPERIMENTAL"},{"description":"Participants will receive SC infusion of newly developed high concentration amivantamab (Ami-HC) or SC injection of amivantamab co-formulated with rHuPH20 (Ami-HC-CF).","label":"Part 2: Ami-HC and Ami-HC-CF","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-04-01","type":"ESTIMATED"},"conditions":["Neoplasms"],"enrollment":{"count":158,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Ami-LC-MD","otherNames":[],"type":"DRUG"},{"name":"Ami-LC","otherNames":[],"type":"DRUG"},{"name":"Ami-HC","otherNames":[],"type":"DRUG"},{"name":"Ami-HC-CF","otherNames":[],"type":"DRUG"}],"last_update":"2026-11-03","lead_sponsor":"Janssen Research & Development, LLC","official_title":"An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Amivantamab, a Human Bispecific EGFR and cMet Antibody for the Treatment of Advanced Solid Malignancies","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2024-07-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)","timeFrame":"Up to Day 29"},{"measure":"Number of Participants with Adverse Event (AE)","timeFrame":"Up to 4 years 1 month"},{"measure":"Number of Participants with Dose Limiting Toxicity (DLT)","timeFrame":"Up to Day 28"},{"measure":"Number of Participants with Clinical Laboratory Abnormalities","timeFrame":"Up to 4 years 1 month"}],"references":[],"start_date":{"date":"2020-11-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies","url":"https://clinicaltrials.gov/study/NCT04606381"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/paloma-nct04606381"}