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NCT06084481 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

A Phase 1 study of Hepatocellular Carcinoma and Head and Neck Squamous Cell Carcinoma, sponsored by AbbVie.

Active
Registry status
Phase 1
Development phase
302
Enrollment target
20
Study locations

NCT06084481 is a Phase 1 study of Hepatocellular Carcinoma and Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 302 participants, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT06084481, a Phase 1 study of Hepatocellular Carcinoma and Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
302 participants
Enrollment target
20
Study locations

Study Summary

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) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 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 and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of ITZ, 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, questi

Conditions Studied

Hepatocellular Carcinoma Head and Neck Squamous Cell Carcinoma Triple Negative Breast Cancer Pancreatic Ductal Adenocarcinoma Esophageal Squamous Cell Carcinoma Biliary Tract Cancers Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer Platinum Resistant High Grade Epithelial Ovarian Cancer

Interventions

  • DRUG ABBV-400
  • DRUG Itraconazole (ITZ)

Study Locations (20)

Texas

  • MD Anderson Cancer Center /ID# 255131 - Houston
  • Univ Texas HSC San Antonio /ID# 257708 - San Antonio
  • South Texas Accelerated Research Therapeutics /ID# 260404 - San Antonio

California

  • City of Hope National Medical Center /ID# 258645 - Duarte
  • Ucsf /Id# 257705 - San Francisco

Colorado

  • University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128 - Aurora
  • Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926 - Denver

Illinois

  • Northwestern University Feinberg School of Medicine /ID# 257378 - Chicago
  • University of Chicago Medical Center /ID# 258197 - Chicago

South Carolina

  • MUSC Hollings Cancer Center /ID# 257935 - Charleston
  • Prisma Health /ID# 257697 - Greenville

Florida

  • Florida Cancer Specialists /ID# 261569 - Sarasota

Michigan

  • START Midwest /ID# 256581 - Grand Rapids

Missouri

  • Washington University-School of Medicine /ID# 257379 - St Louis

Trial Details

FieldValue
Enrollment Target 302 participants
Start Date 2023-11-09
Est. Completion 2026-07
Phase Phase 1

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06084481

The ClinicalTrials.gov registry entry for NCT06084481 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (18% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which ABBV-400 is the first listed.

NCT06084481 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Texas, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT06084481 about?

NCT06084481 is a clinical study titled "Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400". 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...

What is the current status of trial NCT06084481?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 302 participants. The study started on 2023-11-09. Estimated completion is 2026-07.

What conditions does trial NCT06084481 study?

This clinical trial studies the following conditions: Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Squamous Cell Carcinoma.

What interventions are being tested in trial NCT06084481?

The interventions under investigation include: ABBV-400 (DRUG), Itraconazole (ITZ) (DRUG).

Who is sponsoring clinical trial NCT06084481?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06084481 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.