Urothelial Cancer study: PF-08634404 vs Enfortumab Vedotin
Official title Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
ClinicalTrials.gov ID: NCT07421700
What this study is testing
What is PF-08634404?
an investigational biological medicine being studied as a potential treatment for locally advanced or metastatic urothelial cancer
Also referred to as SSGJ-707.
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 a new drug is safe and how well it works. It also looks at how the drug moves through the body.
- Who it's for
- You may be able to join if you are an adult with advanced bladder cancer.
- What's involved
- You would get the new drug through a vein. Some people also get a second cancer medicine.
- Time commitment
- You will have regular visits for treatment and health checks until the study ends.
- Phase 2: a mid-size study of how well it works
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
- Age ≥18 years at the time of screening.
- Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC).
- Measurable disease per RECIST v1.1 criteria.
- ECOG performance status of 0 or 1.
- Adequate organ function, including hematologic, hepatic, and renal parameters.
You likely can't join if
- History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously...
- Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- Active autoimmune diseases requiring systemic treatment within the past 2 years
- Participation in another investigational study within 30 days or 5 half-lives of the investigational product.
- Pregnant or breastfeeding individuals.
- Inability or unwillingness to comply with study requirements.
See the full eligibility criteria
- Age ≥18 years at the time of screening.
- Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC).
- Measurable disease per RECIST v1.1 criteria.
- ECOG performance status of 0 or 1.
- Adequate organ function, including hematologic, hepatic, and renal parameters.
- Willingness to comply with study procedures and provide informed consent.
- For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose.
- History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
- Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- Active autoimmune diseases requiring systemic treatment within the past 2 years
- Participation in another investigational study within 30 days or 5 half-lives of the investigational product.
- Pregnant or breastfeeding individuals.
- Inability or unwillingness to comply with study requirements.
- Study staff or their immediate family members directly involved in the conduct of the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Fayetteville, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Alhambra, California, United States
- Atascadero, California, United States
- Beverly Hills, California, United States
- Burbank, California, United States
- Duarte, California, United States
- Encinitas, California, United States
- Encino, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Laguna Hills, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Marina del Rey, California, United States
- Orange, California, United States
- Pasadena, California, United States
- Porter Ranch, California, United States
- San Diego, California, United States
+ 94 more site(s).
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 Fayetteville, Arkansas, United States; Rogers, Arkansas, United States; Springdale, Arkansas, United States; Alhambra, California, United States; Atascadero, California, United States; Beverly Hills, California, United States and 108 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.