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Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
NCT06084481 · View on ClinicalTrials.gov ↗
Study Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide. In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of 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. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questi
Conditions Studied
Interventions
- DRUG ABBV-400
- DRUG Itraconazole (ITZ)
Study Locations (20)
Texas
- MD Anderson Cancer Center /ID# 255131 — Houston
- Univ Texas HSC San Antonio /ID# 257708 — San Antonio
- South Texas Accelerated Research Therapeutics /ID# 260404 — San Antonio
California
- City of Hope National Medical Center /ID# 258645 — Duarte
- Ucsf /Id# 257705 — San Francisco
Colorado
- University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128 — Aurora
- Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926 — Denver
Illinois
- Northwestern University Feinberg School of Medicine /ID# 257378 — Chicago
- University of Chicago Medical Center /ID# 258197 — Chicago
South Carolina
- MUSC Hollings Cancer Center /ID# 257935 — Charleston
- Prisma Health /ID# 257697 — Greenville
Florida
- Florida Cancer Specialists /ID# 261569 — Sarasota
Michigan
- START Midwest /ID# 256581 — Grand Rapids
Missouri
- Washington University-School of Medicine /ID# 257379 — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2023-11-09 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06084481
The ClinicalTrials.gov registry entry for NCT06084481 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which ABBV-400 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06084481 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06084481 about?
NCT06084481 is a clinical study titled "Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400". Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being...
What is the current status of trial NCT06084481?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 302 participants. The study started on 2023-11-09. Estimated completion is 2026-07.
What conditions does trial NCT06084481 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Triple Negative Breast Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Biliary Tract Cancers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06084481?
The interventions under investigation include: ABBV-400 (DRUG), Itraconazole (ITZ) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06084481?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06084481 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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