Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

a study on Transitional Cell Carcinoma Bladder Cancer Urinary Bladder Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
study ends around

Description

Summary

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.

Official Title

AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER

Keywords

Urothelial Cancer, Advanced/Metastatic Urothelial Cancer, Urothelial Carcinoma, metastatic urothelial cancer, locally advanced urothelial cancer, bladder cancer, PD-1, VEGF, Transitional Cell Carcinoma, Urinary Bladder Neoplasms, enfortumab vedotin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

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.

Locations

  • UCLA Hematology/Oncology - Alhambra not yet accepting patients
    Alhambra California 91801 United States
  • UCLA Hematology/Oncology - Beverly Hills not yet accepting patients
    Beverly Hills California 90212 United States
  • UCLA Hematology/Oncology - Burbank not yet accepting patients
    Burbank California 91505 United States
  • UC San Diego Medical Center - Encinitas accepting new patients
    Encinitas California 92024 United States
  • UCLA Hematology/Oncology - Encino not yet accepting patients
    Encino California 91436 United States
  • UCLA Hematology/Oncology - Irvine not yet accepting patients
    Irvine California 92604 United States
  • UC San Diego Koman Family Outpatient Pavilion accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Shiley Eye Institute accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Sulpizio Cardiovascular Center accepting new patients
    La Jolla California 92037 United States
  • UCLA Hematology Oncology- Laguna Hills not yet accepting patients
    Laguna Hills California 92653 United States
  • (IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology - Marina del Rey not yet accepting patients
    Marina del Rey California 90292 United States
  • UCLA Hematology/Oncology - Pasadena not yet accepting patients
    Pasadena California 91105 United States
  • UCLA Hematology Oncology - Porter Ranch not yet accepting patients
    Porter Ranch California 91326 United States
  • UC San Diego Medical Center - Bankers Hill accepting new patients
    San Diego California 92101 United States
  • UC San Diego McGrath Outpatient Pavilion - Hillcrest accepting new patients
    San Diego California 92103 United States
  • UC San Diego Medical Center- Hillcrest accepting new patients
    San Diego California 92103 United States
  • UC San Diego Medical Center - Rancho Bernardo accepting new patients
    San Diego California 92127 United States
  • UCLA Hematology/Oncology- Santa Monica not yet accepting patients
    Santa Monica California 90404 United States
  • UCLA Hematology/Oncology - Torrance not yet accepting patients
    Torrance California 90505 United States
  • UCLA Hematology/Oncology - Santa Clarita not yet accepting patients
    Valencia California 91355 United States
  • UCLA Hematology/Oncology - Ventura not yet accepting patients
    Ventura California 93003 United States
  • UC San Diego Medical Center - Vista accepting new patients
    Vista California 92081 United States
  • UCLA Hematology/Oncology - Westlake not yet accepting patients
    Westlake Village California 91361 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT07421700
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 132 study participants
Last Updated
Contact us about this trial