STRO-004 treatment in adults with recurrent or metastatic solid tumors
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
PHASE1 · Sutro Biopharma, Inc. · NCT07227168
This study will test whether STRO-004, alone and with pembrolizumab, is safe and can shrink tumors in adults with several types of metastatic cancers that often express Tissue Factor.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sutro Biopharma, Inc. (industry) |
| Drugs / interventions | pembrolizumab |
| Locations | 6 sites (Denver, Colorado and 5 other locations) |
| Trial ID | NCT07227168 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with metastatic or locally advanced solid tumors listed (HNSCC, NSCLC, esophageal/gastric, colorectal, pancreatic, cervical, endometrial, or urothelial), ECOG 0–1, measurable disease, available tumor tissue, adequate organ function, and prior therapies per protocol are ideal candidates.
Not a fit: Patients with untreated brain metastases, certain eye disorders, inadequate organ function, or poor performance status (ECOG ≥2), or those unable to attend required visits at participating centers are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, STRO-004 could provide a new targeted treatment that shrinks tumors and prolongs disease control for patients with Tissue Factor–expressing metastatic cancers.
How similar studies have performed: Other Tissue Factor–targeting ADCs (for example, tisotumab vedotin) have shown clinical activity in some cancers, so the approach has clinical precedent although STRO-004 itself is early-stage.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado and 5 other locations
- SCRI Denver — Denver, Colorado, United States (RECRUITING)
- SCRI FCS Sarasota — Sarasota, Florida, United States (RECRUITING)
- Mass General Cancer Center — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- NEXT Austin — Austin, Texas, United States (RECRUITING)
- NEXT San Antonio — San Antonio, Texas, United States (RECRUITING)
- NEXT Virginia — Fairfax, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Sutro Clinical Development
- Email: ClinicalTrials@sutrobio.com
- Phone: 650-801-6416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC, Esophageal Cancer, Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer