Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
Public ClinicalTrials.gov record NCT06084481. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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), cohort 9 receives ABBV-400 with a strong CYP3A3 inhibitor (ITZ), and cohort 10 receives ABBV-400 with bevacizumab. All cohorts are followed by a safety follow-up period. Approximately 325 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, in cohort 9 participants will receive IV ABBV-400 and an oral solution of ITZ, and in cohort 10 participants will receive IV ABBV-400 and IV 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. 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, questionnaires and side effects.
Study identification
- NCT ID
- NCT06084481
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 325 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 9, 2023 (Actual)
- Primary completion
- Sep 2027 (Estimated)
- Completion
- Sep 2027 (Estimated)
- Last update posted
- Oct 14, 2026
2023 – 2027
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center /ID# 258645 | Duarte | California | 91010 | Recruiting |
| UCSF Medical Center - Mount Zion /ID# 257705 | San Francisco | California | 94115 | Recruiting |
| University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128 | Aurora | Colorado | 80045-7158 | Completed |
| Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926 | Denver | Colorado | 80218 | Recruiting |
| Florida Cancer Specialists- Sarasota Cattlemen /ID# 261569 | Sarasota | Florida | 34232 | Recruiting |
| Northwestern Medicine - Northwestern Memorial Hospital /ID# 257378 | Chicago | Illinois | 60611 | Recruiting |
| University of Chicago Medical Center /ID# 258197 | Chicago | Illinois | 60637 | Recruiting |
| START Midwest /ID# 256581 | Grand Rapids | Michigan | 49546-7062 | Recruiting |
| Washington University /ID# 257379 | St Louis | Missouri | 63110 | Recruiting |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132 | New York | New York | 10065 | Recruiting |
| Duke Cancer Center /ID# 255129 | Durham | North Carolina | 27710 | Recruiting |
| Univ Hosp Cleveland /ID# 257706 | Cleveland | Ohio | 44106 | Recruiting |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693 | Providence | Rhode Island | 02903-4923 | Recruiting |
| MUSC Hollings Cancer Center /ID# 257935 | Charleston | South Carolina | 29425 | Recruiting |
| Prisma Health /ID# 257697 | Greenville | South Carolina | 29605 | Recruiting |
| SCRI Oncology Partners /ID# 261568 | Nashville | Tennessee | 37203 | Recruiting |
| MD Anderson Cancer Center /ID# 255131 | Houston | Texas | 77030 | Recruiting |
| Univ Texas HSC San Antonio /ID# 257708 | San Antonio | Texas | 78229-3901 | Recruiting |
| South Texas Accelerated Research Therapeutics /ID# 260404 | San Antonio | Texas | 78229 | Recruiting |
| Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771 | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06084481, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06084481 live on ClinicalTrials.gov.