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Monoclonal Antibodies

ABBV-400 for Advanced Cancer

Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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 negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), or head and neck squamous-cell-carcinoma (HNSCC) (by World Health Organization [WHO] criteria)
Must not have
Unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia
History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests ABBV-400, a new drug, on adults with difficult-to-treat cancers. The goal is to see how safe it is and how well it works. Patients will be monitored frequently.

Who is the study for?
Adults with certain advanced solid tumors like liver, pancreatic, biliary tract cancers, esophageal squamous cell carcinoma, triple negative breast cancer, hormone receptor+/HER2- breast cancer or head and neck squamous-cell-carcinoma. Participants must have measurable disease activity and meet specific laboratory criteria without active lung issues or recent other cancer treatments.
What is being tested?
The trial is testing ABBV-400 as a monotherapy for up to two years in adults with various advanced solid tumors. Patients are grouped based on their type of cancer and will receive regular medical assessments including blood tests and questionnaires to monitor the treatment's effect.
What are the potential side effects?
Specific side effects of ABBV-400 aren't listed but generally may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection, potential organ inflammation or allergic reactions. Regular monitoring aims to identify any adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an autoimmune or inflammatory condition affecting my lungs, or I've had a lung removed.
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I have been diagnosed with a specific type of advanced cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have no ongoing side effects from cancer treatment above mild, except for hair loss.
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I have a history of serious lung problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Antidrug Antibody (ADA)
Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration
Clinical Benefit Rate
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)Experimental Treatment1 Intervention
Participants with HNSCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Group II: Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)Experimental Treatment1 Intervention
Participants with HR+/HER2-BC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Group III: Cohort 5: Triple Negative Breast Cancer (TNBC)Experimental Treatment1 Intervention
Participants with TNBC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Group IV: Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)Experimental Treatment1 Intervention
Participants with ESCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Group V: Cohort 3: Biliary Tract Cancers (BTC)Experimental Treatment1 Intervention
Participants with BTC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Group VI: Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)Experimental Treatment1 Intervention
Participants with PDAC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Group VII: Cohort 1: Hepatocellular Carcinoma (HCC)Experimental Treatment1 Intervention
Participants with HCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for esophageal cancer include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy uses drugs like cisplatin and fluorouracil to kill rapidly dividing cancer cells by damaging their DNA or interfering with cell division. Radiation therapy uses high-energy rays to destroy cancer cells by causing DNA damage. Targeted therapies, such as those targeting the HER2 protein in HER2-positive cancers, work by interfering with specific molecules involved in cancer cell growth and survival. Investigational drugs like ABBV-400, which are being studied for advanced solid tumors, often target specific pathways or proteins unique to cancer cells, aiming to minimize damage to normal cells and improve treatment efficacy. Understanding these mechanisms is crucial for esophageal cancer patients as it helps in selecting the most appropriate and potentially effective treatment options based on the molecular characteristics of their cancer.

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Who is running the clinical trial?

AbbVieLead Sponsor
1,019 Previous Clinical Trials
519,663 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
441 Previous Clinical Trials
160,112 Total Patients Enrolled
~142 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
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