Actively Recruiting
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
Led by Sutro Biopharma, Inc. · Updated on 2026-03-05
200
Participants Needed
6
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed 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 of 0 to 1
- Received all appropriate systemic therapies that are locally available and eligible
- For Parts 1A and 1C, no limit on number of prior therapies
- For Part 1B, up to 3 prior therapies allowed; up to 4 prior therapies for NSCLC with genomic alterations
- Availability of tumor tissue
- Measurable disease according to RECIST 1.1
- Adequate organ function
- Stable dose of anticoagulants if receiving
You will not qualify if you...
- Eye disorders
- Untreated brain metastases
- Pre-existing clinically significant ocular disorders
- Active interstitial lung disease
- Clinically significant cardiac or cerebrovascular disease
- Other significant concurrent, uncontrolled medical condition
- Previous solid organ or bone marrow transplantation
- Concurrent participation in another therapeutic treatment trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
SCRI Denver
Denver, Colorado, United States, 80218
Actively Recruiting
2
SCRI FCS Sarasota
Sarasota, Florida, United States, 34232
Actively Recruiting
3
Mass General Cancer Center
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
4
NEXT Austin
Austin, Texas, United States, 78758
Actively Recruiting
5
NEXT San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
6
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sutro Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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