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
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AbbVie
- Interventions being studied
- Drug: ABBV-428; Drug: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.