A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- Sutro Biopharma, Inc.
- Study ID
- NCT07227168
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Cervical Cancer
- Colorectal Cancer
- Endometrial Cancer
- Esophageal Cancer
- Gastric Cancer
- Head and Neck Squamous Cell Carcinoma HNSCC
- Non-Small Cell Lung Cancer NSCLC
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Urothelial Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- STRO-004 — DRUGIV Infusion
- Pembrolizumab — DRUGIV Infusion
Study Details
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.
Key Dates
- Start date
- Nov 7, 2025
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2027
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1A STRO-004 Monotherapy
- Experimental: Part 1B STRO-004 Monotherapy
- Experimental: Part 1C STRO-004 in Combination with Pembrolizumab
Primary Outcome Measure
Part 1A: Number of participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Up to Day 21 ]
Central Contacts
- Sutro Clinical Development650-801-6416
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| SCRI Denver | Denver | Colorado | 80218 | Gerald Falchook, MD (PRINCIPAL_INVESTIGATOR) Kim Freitas, MSN (SUB_INVESTIGATOR) |
| SCRI FCS Sarasota | Sarasota | Florida | 34232 | Manish Patel, MD (PRINCIPAL_INVESTIGATOR) Kimberly Ott, MD (SUB_INVESTIGATOR) |
| Mass General Cancer Center | Boston | Massachusetts | 02114 | Leon Pappas, MD (PRINCIPAL_INVESTIGATOR) |
| NEXT Austin | Austin | Texas | 78758 | Andrae Vandross, MD (PRINCIPAL_INVESTIGATOR) Sheena Sahota, MD (SUB_INVESTIGATOR) |
| NEXT San Antonio | San Antonio | Texas | 78229 | David Sommerhalder, MD (PRINCIPAL_INVESTIGATOR) Ismael Rodriguez, MD (SUB_INVESTIGATOR) |
| NEXT Virginia | Fairfax | Virginia | 22031 | Mohamad A. Salkeni, MD (PRINCIPAL_INVESTIGATOR) Neel Belani, MD (SUB_INVESTIGATOR) |
Find similar trials in Denver, CO
Related Studies
- Evaluation of Non-Invasive Assays for the Detection of Urothelial CancerRecruiting · Lahey Clinic · Burlington, Massachusetts
- Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal VolunteersRecruiting · University of Colorado, Denver · Aurora, Colorado
- Integrated Cancer Repository for Cancer ResearchRecruiting · University of Nebraska · Greenwood Village, Colorado
- ColoCare Study - Colorectal Cancer CohortRecruiting · University of Utah · Los Angeles, California