๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-05-21

Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors (NCT03821935)

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Locally Advanced or Metastatic Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: AbbVie

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.

Who can join: Review the eligibility criteria below.

Location: Highlands Oncology Group, PA /ID# 218942 โ€” Springdale, Arkansas

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (64 Sites)

Showing the first 25 of 64 sites.

  • Highlands Oncology Group, PA /ID# 218942 โ€” Springdale, Arkansas
  • City of Hope National Medical Center /ID# 265620 โ€” Duarte, California
  • City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785 โ€” Irvine, California
  • Yale University School of Medicine /ID# 208356 โ€” New Haven, Connecticut
  • AdventHealth Celebration /ID# 224860 โ€” Celebration, Florida
  • Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953 โ€” Orlando, Florida
  • Indiana Univ School Medicine /ID# 208384 โ€” Indianapolis, Indiana
  • Community Health Network, Inc. /ID# 257032 โ€” Indianapolis, Indiana
  • Univ Michigan Med Ctr /ID# 221129 โ€” Ann Arbor, Michigan
  • Washington University-School of Medicine /ID# 259684 โ€” St Louis, Missouri
  • Intermountain Health West End Clinic Gynecologic Oncology /ID# 266171 โ€” Billings, Montana
  • NYU Langone Medical Center /ID# 209822 โ€” New York, New York
  • Icahn School of Medicine at Mount Sinai /ID# 264653 โ€” New York, New York
  • Carolina BioOncology Institute /ID# 208358 โ€” Huntersville, North Carolina
  • The Ohio State University - The James /ID# 217611 โ€” Columbus, Ohio
  • Ou Health - Stephenson Cancer Center /ID# 268826 โ€” Oklahoma City, Oklahoma
  • Sarah Cannon Research Institute (SMO/Network/Consortium) /ID# 264900 โ€” Nashville, Tennessee
  • Renovatio clinical /ID# 265109 โ€” El Paso, Texas
  • NEXT Oncology /ID# 208930 โ€” San Antonio, Texas
  • Renovatio Clinical /ID# 265054 โ€” The Woodlands, Texas
  • University of Washington Medical Center /ID# 268854 โ€” Seattle, Washington
  • Chris O'Brien Lifehouse /ID# 213236 โ€” Camperdown, New South Wales
  • Icon Cancer Centre /ID# 224961 โ€” South Brisbane, Queensland
  • Cliniques Universitaires UCL Saint-Luc /ID# 218466 โ€” Brussels, Brussels Capital
  • University Health Network_Princess Margaret Cancer Centre /ID# 209423 โ€” Toronto, Ontario

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—