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RECRUITING
NCT07227168
PHASE1

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

Sponsor: Sutro Biopharma, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

STRO-004

IV Infusion

DRUG

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

NEXT Austin

Austin, Texas, United States

NEXT San Antonio

San Antonio, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States