๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-11-13

Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 (NCT04787042)

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Simcha IL-18, Inc.

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

This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyvaยฎ\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.

Who can join: Review the eligibility criteria below.

Location: HonorHealth Research Institute โ€” Scottsdale, Arizona

Age range: 18 Years

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 (6 Sites)

  • HonorHealth Research Institute โ€” Scottsdale, Arizona
  • Sarah Cannon Research Institute at HealthONE โ€” Denver, Colorado
  • Yale Cancer Center โ€” New Haven, Connecticut
  • Moffitt Cancer Center โ€” Tampa, Florida
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Roswell Park Cancer Institute โ€” Buffalo, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (805) 300-3912

Email: beatrice@simchatherapeutics.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.

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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†—