Clinical trial for Hepatocellular Carcinoma
Official 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
ClinicalTrials.gov ID: NCT06084481
What this study is testing
What is ABBV-400?
ABBV-400 is an investigational intravenous drug being studied as a potential treatment for advanced solid tumors, including hepatocellular carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see what side‑effects occur and whether the drug changes how active the cancer is.
- Who it's for
- Adults with advanced solid tumors including liver, pancreas, bile duct, esophageal, breast, head and neck, or ovarian cancers.
- What's involved
- Participants receive IV ABBV‑400 alone or with other medicines, attend regular clinic visits, and have blood tests, questionnaires, and medical checks to monitor safety and disease activity.
- Time commitment
- The study can last up to 3 years of treatment plus up to 2 years of follow‑up, with frequent visits at the study site.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Laboratory values meeting the criteria laid out in the protocol.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers...
You likely can't join if
- Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or...
- Unresolved clinically significant AEs \> Grade 1 from prior anticancer therapy.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or...
- History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol.
- Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid...
- History of other active malignancy, with the exception of those laid out in the protocol.
See the full eligibility criteria
- Laboratory values meeting the criteria laid out in the protocol.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple...
- Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first...
- Unresolved clinically significant AEs \> Grade 1 from prior anticancer therapy.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol.
- History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol.
- Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic...
- History of other active malignancy, with the exception of those laid out in the protocol.
- Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Sarasota, Florida, United States
- Chicago, Illinois, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Providence, Rhode Island, United States
- Charleston, South Carolina, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Camperdown, New South Wales, Australia
- Heidelberg, Victoria, Australia
- Petah Tikva, Central District, Israel
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Sarasota, Florida, United States; Chicago, Illinois, United States; Grand Rapids, Michigan, United States and 34 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.