STRO-004 treatment in adults with recurrent or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, first-in-human study of STRO-004, an antibody–drug conjugate targeting Tissue Factor, conducted in three parts: dose escalation of STRO-004 monotherapy (Part 1A), cohort expansion to select a recommended monotherapy dose and examine anti-tumor activity (Part 1B), and dose escalation of STRO-004 combined with pembrolizumab (Part 1C). The study enrolls adults with a range of metastatic or locally advanced solid tumors known to commonly express Tissue Factor and requires measurable disease and available tumor tissue. Primary focuses are safety, tolerability, dose finding, and preliminary anti-tumor activity using standard response criteria. Participants will undergo regular safety monitoring, tumor assessments per RECIST 1.1, and laboratory evaluations to define dose-limiting toxicities and recommended doses for later studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal/Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma
* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies
* Availability of tumor tissue
* Measurable disease per RECIST 1.1
* Adequate organ function
* Participants receiving anticoagulants must be on a stable dose

Exclusion Criteria:

* Eye disorders
* Untreated brain metastases
* Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
* Previous solid organ or bone marrow transplantation
* Concurrent participation in another therapeutic treatment trial

Where it's running

• UC San Diego Moores Cancer Center
  San Diego, California, United States Recruiting
• SCRI Denver
  Denver, Colorado, United States Recruiting
• Georgetown University Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• SCRI FCS Sarasota
  Sarasota, Florida, United States Recruiting
• Mass General Cancer Center
  Boston, Massachusetts, United States Recruiting
• Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Sutro Clinical Development
• Email: ClinicalTrials@sutrobio.com
• Phone: 650-801-6416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.