Head and Neck Squamous Cell Carcinoma HNSCC study: STRO-004 vs Pembrolizumab
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 IV infusion 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 study is testing whether STRO-004 is safe and may help fight cancer. It also looks at how well it works with another drug, pembrolizumab.
- Who it's for
- You may be able to join if you are an adult with certain advanced cancers like head and neck, lung, esophageal, stomach, colorectal, pancreatic, cervical, endometrial, or bladder cancer.
- What's involved
- You would receive STRO-004, either alone or with pembrolizumab, in a hospital setting. You will have regular visits for blood tests and scans to check safety and tumor response.
- Time commitment
- The study lasts about 6 to 12 weeks, with several clinic visits for treatment and monitoring.
- 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.
- 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.
- 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 is enrolling
- San Diego, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Sarasota, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, 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, but 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?
This study is enrolling now at San Diego, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Sarasota, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.