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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors Cancer

In brief

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.

Key facts

Study ID

NCT02955251

Run by

AbbVie

People needed

61

Starts

2016-11-18

Expected to finish

2019-10-29

Last updated by the study team

2020-07-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• HonorHealth Research Institute - Pima /ID# 155461 — Scottsdale, Arizona, United States
• UC Davis Comprehensive Cancer Center - Main /ID# 154439 — Sacramento, California, United States
• University of Chicago /ID# 154440 — Chicago, Illinois, United States
• Fox Chase Cancer Center /ID# 170665 — Philadelphia, Pennsylvania, United States
• Greenville Hospital System /ID# 154437 — Greenville, South Carolina, United States
• MD Anderson Cancer Center at Texas Medical Center /ID# 154441 — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics /ID# 154442 — San Antonio, Texas, United States
• Chris O'Brien Lifehouse /ID# 163131 — Camperdown, New South Wales, Australia
• Northern Cancer Institute /ID# 163132 — St Leonards, New South Wales, Australia
• Institut Bergonie /ID# 202391 — Bordeaux, Gironde, France
• Hopital de la Timone /ID# 162256 — Marseille, Provence-Alpes-Côte d'Azur Region, France
• Centre Leon Berard /ID# 168072 — Lyon, Rhone, France
• Institut Curie /ID# 162258 — Paris, Île-de-France Region, France
• Gustave Roussy /ID# 162257 — Villejuif, Île-de-France Region, France
• National Taiwan Univ Hosp /ID# 169034 — Taipei City, Taipei, Taiwan

Full record on ClinicalTrials.gov

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