A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

Study summary

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedABBV-428 and Nivolumab

The study team can explain what participation involves.

Who it may be forAdvanced Solid Tumors Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 20, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: AbbVie
Interventions being studied: Drug: ABBV-428; Drug: Nivolumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
Participants have adequate bone marrow, renal, hepatic and coagulation function.
For all dose expansion arms, participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.

Reasons someone may not be able to joinExclusion criteria

Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

HonorHealth Research Institute - Pima /ID# 155461Scottsdale, Arizona
UC Davis Comprehensive Cancer Center - Main /ID# 154439Sacramento, California
University of Chicago /ID# 154440Chicago, Illinois
Fox Chase Cancer Center /ID# 170665Philadelphia, Pennsylvania
Greenville Hospital System /ID# 154437Greenville, South Carolina
MD Anderson Cancer Center at Texas Medical Center /ID# 154441Houston, Texas
South Texas Accelerated Research Therapeutics /ID# 154442San Antonio, Texas
Chris O'Brien Lifehouse /ID# 163131Camperdown, New South Wales
Northern Cancer Institute /ID# 163132St Leonards, New South Wales
Institut Bergonie /ID# 202391Bordeaux, Gironde
Hopital de la Timone /ID# 162256Marseille, Provence-Alpes-Côte d'Azur Region
Centre Leon Berard /ID# 168072Lyon, Rhone

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 20, 2020. Always confirm current availability with the study team.

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