๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-18

A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas. (NCT06022029)

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: OncoNano Medicine, Inc.

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

A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.

Who can join: Review the eligibility criteria below.

Location: California Research Institute โ€” Los Angeles, California

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 (16 Sites)

  • California Research Institute โ€” Los Angeles, California
  • BRCR Global โ€” Tamarac, Florida
  • Gabrail Cancer Center Research โ€” Canton, Ohio
  • Ohio State University โ€” Columbus, Ohio
  • Allegheny Health Network โ€” Pittsburgh, Pennsylvania
  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania
  • University of Texas Southwestern Medical Center โ€” Dallas, Texas
  • MD Anderson Cancer Center โ€” Houston, Texas
  • Virginia Cancer Specialists, PC โ€” Fairfax, Virginia
  • St Vincent's Hospital โ€” Darlinghurst, New South Wales
  • Cancer Care Wollongong โ€” Wollongong, New South Wales
  • University of the Sunshine Coast Clinical Trials โ€” Buderim, Queensland
  • Tasman Oncology Research โ€” Southport, Queensland
  • Princess Alexandra Hospital | Metro South Health โ€” Woolloongabba, Queensland
  • Southern Oncology Clinical Research Unit โ€” Bedford Park, South Australia
  • St John of God Subiaco Hospital โ€” Subiaco, Western Australia

๐Ÿ“ž Contact the Study Coordinator

Phone: (682) 285-1411

Email: trials@onconanomed.com

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

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. 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.
๐Ÿ›๏ธ View Official NIH Record โ†—