Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
Purpose
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.
Conditions
- Urothelial Cancer
- Advanced/Metastatic Urothelial Cancer
- Urothelial Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A |
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy. |
|
|
Experimental Cohort B |
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin |
|
Recruiting Locations
Fayetteville, Arkansas 72703
Rogers, Arkansas 72758
Springdale, Arkansas 72762
Duarte, California 91010
Duarte, California 91010
Irvine, California 92618
Irvine, California 92618
Long Beach, California 90813
Upland, California 91786
Aurora, Colorado 80012
Denver, Colorado 80218
Lone Tree, Colorado 80124
Norwich, Connecticut 06360
Albany, New York 12206
Clifton Park, New York 12065
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Austin, Texas 78705
Austin, Texas 78731
Austin, Texas 78745
Austin, Texas 78758
Beaumont, Texas 77702
Harlingen, Texas 78550
Houston, Texas 77024
Houston, Texas 77054
Irving, Texas 75063
McAllen, Texas 78503
Pearland, Texas 77584
Sugar Land, Texas 77479
The Woodlands, Texas 77380
Waco, Texas 76712
Webster, Texas 77598
Blacksburg, Virginia 24060
Fairfax, Virginia 22031
Low Moor, Virginia 24457
Norfolk, Virginia 23502
Roanoke, Virginia 24014
Salem, Virginia 24153
Wytheville, Virginia 24382
Manati, Puerto Rico 00674
Mayagüez, Puerto Rico 00680
Rio Piedras, Puerto Rico 00935
Rio Piedras, Puerto Rico 00935
More Details
- Status
- Recruiting
- Sponsor
- Pfizer