๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-10-27

Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab (NCT06249048)

A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Strand Therapeutics Inc.

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

Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab. The study now includes a monotherapy cohort targeting visceral lesions and a separate Phase 2 monotherapy cohort for advanced melanoma.

Who can join: Review the eligibility criteria below.

Location: HonorHealth Research and Innovation Institute โ€” Scottsdale, Arizona

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 (7 Sites)

  • HonorHealth Research and Innovation Institute โ€” Scottsdale, Arizona
  • NextGen Oncology โ€” Beverly Hills, California
  • Cleveland Clinic โ€” Cleveland, Ohio
  • University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania
  • The University of Texas MD Anderson Cancer Center โ€” Houston, Texas
  • Huntsman Cancer Institute - University of Utah โ€” Salt Lake City, Utah
  • Melanoma Institute Australia โ€” Wollstonecraft,

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 993-9281

Email: stx001.inquiry@strandtx.us

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†—