🏛️ Verified NIH Record • Updated 2026-05-01

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (NCT05599984)

A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: AbbVie

🩺 Plain-English Summary (8th-Grade Level)

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 319 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 4 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Who can join: Review the eligibility criteria below.

Location: Banner MD Anderson Cancer Ctr /ID# 260129 — Gilbert, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (66 Sites)

Showing the first 25 of 66 sites.

  • Banner MD Anderson Cancer Ctr /ID# 260129 — Gilbert, Arizona
  • City Of Hope Comprehensive Cancer Center /ID# 271295 — Duarte, California
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884 — Irvine, California
  • Yale New Haven Hospital /ID# 246647 — New Haven, Connecticut
  • Georgetown University Hospital /ID# 255352 — Washington D.C., District of Columbia
  • University of Chicago Medical Center /ID# 256334 — Chicago, Illinois
  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130 — Fort Wayne, Indiana
  • University of Iowa Hospitals and Clinics /ID# 246638 — Iowa City, Iowa
  • Barbara Ann Karmanos Cancer In /ID# 261799 — Detroit, Michigan
  • Henry Ford Hospital /ID# 246648 — Detroit, Michigan
  • START Midwest /ID# 251257 — Grand Rapids, Michigan
  • St. Lukes Hosp. of Kansas City /ID# 259958 — Kansas City, Missouri
  • Washington University-School of Medicine /ID# 246286 — St Louis, Missouri
  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303 — New York, New York
  • Duke Cancer Center /ID# 246285 — Durham, North Carolina
  • UH Cleveland Medical Center /ID# 246641 — Cleveland, Ohio
  • Univ Oklahoma HSC /ID# 250884 — Oklahoma City, Oklahoma
  • Tennessee Oncology, PLLC /ID# 246283 — Nashville, Tennessee
  • University of Texas MD Anderson Cancer Center /ID# 246287 — Houston, Texas
  • South Texas Accelerated Research Therapeutics /ID# 248946 — San Antonio, Texas
  • University of Utah /ID# 246640 — Salt Lake City, Utah
  • Northwest Medical Specialties - Tacoma /ID# 262801 — Tacoma, Washington
  • Chris O'Brien Lifehouse /ID# 259087 — Camperdown, New South Wales
  • The Kinghorn Cancer Centre /ID# 260874 — Darlinghurst, New South Wales
  • Austin Health and Ludwig Institute for Cancer Research /ID# 255174 — Heidelberg, Victoria

📞 Contact the Study Coordinator

Phone: (877) 632-6789

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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 § 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.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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.
🏛️ View Official NIH Record ↗