{"preliminary_commentary":{"by_channel":{"x_thread":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":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT06084481","nct_id":"NCT06084481","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct06084481. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 1: Hepatocellular Carcinoma (HCC)","type":"EXPERIMENTAL"},{"description":"Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)","type":"EXPERIMENTAL"},{"description":"Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 3: Biliary Tract Cancers (BTC)","type":"EXPERIMENTAL"},{"description":"Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)","type":"EXPERIMENTAL"},{"description":"Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 5: Triple Negative Breast Cancer (TNBC)","type":"EXPERIMENTAL"},{"description":"Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)","type":"EXPERIMENTAL"},{"description":"Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)","type":"EXPERIMENTAL"},{"description":"Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer","type":"EXPERIMENTAL"},{"description":"Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 9: Drug-Drug Interaction","type":"EXPERIMENTAL"},{"description":"Participants with PROC/primary peritoneal/fallopian tube cancer will receive ABBV-400 in combination with bevacizumab for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.","label":"Cohort 10: PROC/Primary Peritoneal/Fallopian Tube Cancer","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-09","type":"ESTIMATED"},"conditions":["Hepatocellular Carcinoma","Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancers","Esophageal Squamous Cell Carcinoma","Triple Negative Breast Cancer","Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer","Head and Neck Squamous-Cell Carcinoma","Platinum Resistant High Grade Epithelial Ovarian Cancer"],"enrollment":{"count":325,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"ABBV-400","otherNames":[],"type":"DRUG"},{"name":"Itraconazole (ITZ)","otherNames":[],"type":"DRUG"},{"name":"Bevacizumab","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-14","lead_sponsor":"AbbVie","official_title":"A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications","overall_status":"RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2027-09","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR)","timeFrame":"Up to 36 Months"},{"measure":"Number of Participants with Adverse Events (AEs)","timeFrame":"Up to 36 Months"},{"measure":"Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate","timeFrame":"Up to 36 Months"},{"measure":"AUC from Time 0 to the End of Dosing Interval (AUCtau) of ABBV-400 Conjugate","timeFrame":"Up to 36 Months"}],"references":[],"start_date":{"date":"2023-11-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400","url":"https://clinicaltrials.gov/study/NCT06084481"},"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/nct06084481"}