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NCT Number: NCT07421700

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

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.

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Key information

Conditions

Urothelial Cancer Advanced/Metastatic Urothelial Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Macquarie University, North Ryde, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-08634404

Biological

Concentrate for solution for Infusion.

Other names: SSGJ-707

Enfortumab Vedotin

Biological

Powder for concentrate for solution for infusion

Other names: PF-08046042, ASG-22CE, PADCEV

Primary outcomes

  1. Confirmed Objective Response Rate (ORR) by investigator

    Time frame: Up to approximately 3 years

    ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator.

  2. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Through 90 days after the last study intervention; Up to approximately 3 years

    AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention.

  3. Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B

    Time frame: Through 90 days after the last study intervention; Up to approximately 3 years

    The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV.

Secondary outcomes

  1. Duration of Response (DOR) per RECIST v1.1 by investigator

    Time frame: Up to approximately 3 years

    DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.

  2. Progression Free Survival (PFS) per RECIST v1.1 by investigator

    Time frame: Up to approximately 3 years

    Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.

  3. Overall Survival (OS)

    Time frame: Up to approximately 3 years

    Overall survival defined as the time from the date of C1D1 to the date of death due to any cause.

  4. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Through 90 days after the last study intervention; Up to approximately 3 years

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0)

  5. Pharmacokinetics (PK): Serum concentration of PF-08634404

    Time frame: Up to 37 days after the last dose of treatment

    To characterize the pharmacokinetics (PK) of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC.

  6. Incidence of Anti-Drug Antibody (ADA) against PF-08634404

    Time frame: Up to 37 days after the last dose of treatment

    To evaluate the immunogenicity of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Astellas Pharma Inc

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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