NCT07227168 A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
| NCT ID | NCT07227168 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sutro Biopharma, Inc. |
| Condition | Head and Neck Squamous Cell Carcinoma HNSCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2025-11-07 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07227168 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma HNSCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07227168 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07227168 currently recruiting?
Yes, NCT07227168 is actively recruiting participants. Contact the research team at ClinicalTrials@sutrobio.com for enrollment information.
Where is the NCT07227168 trial being conducted?
This trial is being conducted at Denver, United States, Sarasota, United States, Boston, United States, Austin, United States and 2 additional locations.
Who is sponsoring the NCT07227168 clinical trial?
NCT07227168 is sponsored by Sutro Biopharma, Inc.. The trial plans to enroll 200 participants.