drugset / Trial / NCT07227168

A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer

NCT07227168 ↗

Phase 1 Recruiting 200 enrolled Sutro Biopharma, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-11-07
Primary completion
2027-12
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody — Intravenous
Subject STRO-004 Unknown — Intravenous