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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial assesses the effectiveness & safety of ABBV-400 for treating advanced solid tumors in adults.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Antidrug Antibody (ADA)

Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration

Clinical Benefit Rate

+8 more

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,170 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,889 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are participating in this trial currently?

"For this study to be conducted, AbbVie must recruit 220 participants who meet the inclusion criteria. The trial will take place at Duke Cancer Center/ID# 255129 in Durham, North carolina and South Texas Accelerated Research Therapeutics/ ID# 260404 in San Antonio, Texas."

Answered by AI

Is the enrollment for this research project still taking place?

"Presently, this medical study is in search of willing participants. The trial was originally posted on November 9th 2023 and the information has been updated most recently on November 13th 2023 as per clinicaltrials.gov's records."

Answered by AI