TrialPath
← Back to searchRecruiting

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

NCT07227168 · Sutro Biopharma, Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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
About this study
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 criteria
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
Study design
Enrollment target: 200 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-07
Estimated completion: 2028-04
Last updated: 2026-03-05
Interventions
Drug: STRO-004Drug: Pembrolizumab
Primary outcomes
  • Part 1A: Number of participants with Dose-limiting Toxicities (DLTs) (Up to Day 21)
  • Part 1A, 1B: Percentage of participants with Treatment-Emergent Adverse Events (TEAEs), with severity determined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale (Up to 12 Months)
  • Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scale (Up to 12 months)
Sponsor
Sutro Biopharma, Inc. · industry
Contacts & investigators
ContactSutro Clinical Development · contact · ClinicalTrials@sutrobio.com · 650-801-6416
All locations (6)
SCRI DenverRecruiting
Denver, Colorado, United States
SCRI FCS SarasotaRecruiting
Sarasota, Florida, United States
Mass General Cancer CenterNot Yet Recruiting
Boston, Massachusetts, United States
NEXT AustinRecruiting
Austin, Texas, United States
NEXT San AntonioRecruiting
San Antonio, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer · TrialPath