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New treatment option for Head and Neck Squamous Cell Carcinoma HNSCC
Official title A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
ClinicalTrials.gov ID: NCT07227168
What this study is testing
What is STRO-004?
STRO-004 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma hnscc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small...
- 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...
- Availability of tumor tissue
You likely can't join if
- Eye disorders
- Untreated brain metastases
- Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or...
- Previous solid organ or bone marrow transplantation
- Concurrent participation in another therapeutic treatment trial
See the full eligibility 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...
- 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...
- Availability of tumor tissue
- Measurable disease per RECIST 1.1
- Adequate organ function
- Participants receiving anticoagulants must be on a stable dose
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Sarasota, Florida, United States
- Boston, Massachusetts, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Sarasota, Florida, United States; Boston, Massachusetts, United States; Austin, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.