Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (NCT04140526)
Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)
🩺 Plain-English Summary (8th-Grade Level)
This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group — Springdale, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- Highlands Oncology Group — Springdale, Arkansas
- University of California at Davis — Davis, California
- The Oncology Institute of Hope and Innovation — Downey, California
- City of Hope Cancer Center — Duarte, California
- University of Colorado Hospital — Aurora, Colorado
- Nuvance Health — Norwalk, Connecticut
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- Florida Cancer Specialists — Atlantis, Florida
- University of Florida Health Cancer Center — Gainesville, Florida
- Ocala Oncology Florida Cancer Affiliates — Ocala, Florida
- AdventHealth Cancer Institute — Orlando, Florida
- Memorial Cancer Institute — Pembroke Pines, Florida
- Emory University Winship Cancer Institute — Atlanta, Georgia
- Norton Health — Lexington, Kentucky
- Greater Baltimore Medical Center — Baltimore, Maryland
- The Center for Cancer and Blood Disorders — Bethesda, Maryland
- Dana Farber Cancer Institute — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- University of Michigan Medical Center — Ann Arbor, Michigan
- Atlantic Healthcare System — Morristown, New Jersey
- Memorial Sloan Kettering Cancer Center — New York, New York
- University of Cincinnati Medical Center — Cincinnati, Ohio
- The Ohio State University James Cancer Center — Columbus, Ohio
- Zangmeister Cancer Center — Columbus, Ohio
- Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center) — Gettysburg, Pennsylvania
💰 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
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.