RecruitingPhase 1NCT07227168

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

Sponsor

Sutro Biopharma, Inc.

Enrollment

200 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called STRO-004 in adults with advanced or metastatic cancers including head and neck, lung, esophageal, colorectal, pancreatic, cervical, endometrial, and bladder cancers that have come back or did not respond to previous treatments. **You may be eligible if...** - You are 18 or older with a confirmed advanced or metastatic solid tumor (specific cancer types apply) - You have already tried all appropriate standard treatments available to you - You have at least one measurable tumor - Your general health is good (ECOG 0 or 1) - Tumor tissue is available for analysis **You may NOT be eligible if...** - You have serious eye disorders - You have untreated brain metastases - You have active interstitial lung disease or significant heart or blood vessel problems - You have had a prior organ or bone marrow transplant - You are currently in another treatment clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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