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
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ 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.
๐ฐ 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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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.