NCT07227168

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sutro Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma HNSCC
• Non-Small Cell Lung Cancer NSCLC
• Esophageal Cancer
• Gastric Cancer
• Colorectal Cancer
• Pancreatic Ductal Adenocarcinoma (PDAC)
• Cervical Cancer
• Endometrial Cancer
• Urothelial Cancer

Interventions

Type	Name	Description
DRUG	STRO-004	IV Infusion
DRUG	Pembrolizumab	IV Infusion

Timeline

• Start date: 2025-11-07
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2025-11-12
• Last updated: 2026-03-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study