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)
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center /ID# 258645 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (54 Sites)
Showing the first 25 of 54 sites.
- City of Hope National Medical Center /ID# 258645 — Duarte, California
- UCSF Medical Center - Mount Zion /ID# 257705 — San Francisco, California
- University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128 — Aurora, Colorado
- Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926 — Denver, Colorado
- Florida Cancer Specialists /ID# 261569 — Sarasota, Florida
- Northwestern University Feinberg School of Medicine /ID# 257378 — Chicago, Illinois
- University of Chicago Medical Center /ID# 258197 — Chicago, Illinois
- START Midwest /ID# 256581 — Grand Rapids, Michigan
- Washington University-School of Medicine /ID# 257379 — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132 — New York, New York
- Duke Cancer Center /ID# 255129 — Durham, North Carolina
- Univ Hosp Cleveland /ID# 257706 — Cleveland, Ohio
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693 — Providence, Rhode Island
- MUSC Hollings Cancer Center /ID# 257935 — Charleston, South Carolina
- Prisma Health /ID# 257697 — Greenville, South Carolina
- Tennessee Oncology-Nashville Centennial /ID# 261568 — Nashville, Tennessee
- MD Anderson Cancer Center /ID# 255131 — Houston, Texas
- Univ Texas HSC San Antonio /ID# 257708 — San Antonio, Texas
- START-San Antonio — San Antonio, Texas
- Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771 — Fairfax, Virginia
- Chris O'Brien Lifehouse /ID# 262765 — Camperdown, New South Wales
- Austin Health /ID# 256635 — Heidelberg, Victoria
- Rabin Medical Center. /ID# 256650 — Petah Tikva, Central District
- The Chaim Sheba Medical Center /ID# 255731 — Ramat Gan, Tel Aviv
- Tel Aviv Sourasky Medical Center /ID# 258931 — Tel Aviv, Tel Aviv
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.