Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
Фаза 1/2 – комбинирано ранно изпитване
Заболявания:
Urothelial Cancer
Advanced/Metastatic Urothelial Cancer
Urothelial Carcinoma
Спонсор: Pfizer
Налично на:
БГ
Обобщение
This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA/mUC), meaning the cancer has spread to nearby tissues or other parts of the body.
The purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects the cancer. The study will also look at how the medicine may change certain markers in the body that are linked to cancer.
To join the study, participants must:
* Be adults (18 years or older) and
* Have locally advanced or metastatic urothelial cancer,
The study has two groups:
* Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone.
* Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin.
Everyone in the study will get the study medicine through a vein (IV infusion) with or without enfortumab vedotin. Treatment will continue as long as it helps and side effects are manageable.
Before starting, participants will go through a screening period to check if they are eligible. During the study, they will have regular visits for treatment, health checks, and tests to see how the cancer is responding. Scans will be done regularly to monitor the cancer.
If the cancer gets worse but the treatment is still helping and side effects are manageable, participants may be allowed to continue treatment with their doctor's and the sponsor's agreement.
Кой може да участва
Inclusion 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.
Exclusion Criteria:
Participants will be excluded if they meet any of the following:
* 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.
Интервенции
PF-08634404
BIOLOGICAL
Enfortumab Vedotin
BIOLOGICAL
Места на провеждане
40
Австралия (1)
Icon Cancer Centre Wesley
Auchenflower , Queensland
Япония (2)
Keio university hospital
Shinjuku-ku , Tokyo
NOT_YET_RECRUITING
Yamagata University Hospital
Yamagata
NOT_YET_RECRUITING
Puerto Rico (2)
Pan American Center for Oncology Trials, LLC
Rio Piedras
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras
САЩ (35)
New York Oncology Hematology
Albany , New York
NOT_YET_RECRUITING
Rocky Mountain Cancer Centers, LLP
Aurora , Colorado
Texas Oncology - Central/South Texas
Austin , Texas
Texas Oncology - Austin
Austin , Texas
Texas Oncology - Central/South Texas
Austin , Texas
Texas Oncology - Central/South Texas
Austin , Texas
Texas Oncology - Central South
Austin , Texas
Texas Oncology - Central/South Texas
Austin , Texas
Texas Oncology - Gulf Coast
Beaumont , Texas
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Blacksburg , Virginia
New York Oncology Hematology
Clifton Park , New York
NOT_YET_RECRUITING
Rocky Mountain Cancer Centers, LLP
Denver , Colorado
Virginia Cancer Specialists, PC
Fairfax , Virginia
Highlands Oncology Group, PA
Fayetteville , Arkansas
NOT_YET_RECRUITING
Texas Oncology - Central/South Texas
Harlingen , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Texas Oncology - Gulf Coast
Houston , Texas
US Oncology Investigational Products Center (IPC)
Irving , Texas
NOT_YET_RECRUITING
Rocky Mountain Cancer Centers, LLP
Lone Tree , Colorado
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Low Moor , Virginia
Texas Oncology - Central/South Texas
McAllen , Texas
Sarah Cannon Research Institute
Nashville , Tennessee
SCRI Oncology Partners
Nashville , Tennessee
Virginia Oncology Associates
Norfolk , Virginia
NOT_YET_RECRUITING
Eastern Connecticut Hematology and Oncology Associates
Norwich , Connecticut
NOT_YET_RECRUITING
Texas Oncology - Gulf Coast
Pearland , Texas
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Roanoke , Virginia
Highlands Oncology Group, PA
Rogers , Arkansas
NOT_YET_RECRUITING
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Salem , Virginia
Highlands Oncology Group, PA
Springdale , Arkansas
NOT_YET_RECRUITING
Texas Oncology - Gulf Coast
Sugar Land , Texas
Texas Oncology - Gulf Coast
The Woodlands , Texas
Texas Oncology - Central/South Texas
Waco , Texas
Texas Oncology - Gulf Coast
Webster , Texas
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care