CompletedPhase 1NCT02955251

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

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.

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

StatusCompleted
PhasePhase 1
U.S. locations15
SponsorAbbVie
01
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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Explore related studies

How this study is categorized

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

Treatment approach
03
Public criteria

Who may be able to participate

Inclusion 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. Exclusion 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.

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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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