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A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
Sponsor: Sutro Biopharma, Inc.
Summary
This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts: * Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF). * Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity. * Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.
Official title: A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-11-07
Completion Date
2028-04
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
STRO-004
IV Infusion
Pembrolizumab
IV Infusion
Locations (6)
SCRI Denver
Denver, Colorado, United States
SCRI FCS Sarasota
Sarasota, Florida, United States
Mass General Cancer Center
Boston, Massachusetts, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Fairfax, Virginia, United States