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RecruitingLast updated: 4 August 2026

Symbiotic-GU-06: Testing a new medicine (called PF-08634404) for people with locally advanced or metastatic urothelial cancerAN 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

Symbiotic-GU-06

Clinical summary

Summary

This study is testing a new medicine called PF-08634404 in people 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.

Researchers want to learn:

  • How safe PF-08634404 is
  • How well it works against cancer
  • How the body processes the medicine
  • How the medicine affects cancer-related markers in the body

Who can take part?
You may be able to join if you:

  • Are aged 18 years or older
  • Have locally advanced or metastatic urothelial cancer

What treatment will I receive?
Participants in this study will be placed in one of two groups:

  • Cohort A:
    • For people who have previously received treatment for their cancer
    • Participants will receive PF-08634404 on its own
  • Cohort B:
    • For people who have not received treatment for their advanced cancer
    • Participants will receive PF-08634404 together with another medicine called enfortumab vedotin

The study medicines are given through a drip into a vein (intravenous or IV infusion).

What does participation involve?
Before starting treatment, you will complete a screening period to check whether the study is suitable for you.

During the study, you will attend regular clinic visits for:
  • Treatment
  • Physical examinations and health checks
  • Blood tests and other assessments
  • Scans to monitor your cancer and see how it is responding to treatment
Treatment will continue for as long as it is helping control the cancer and side effects remain manageable.
 
In some situations, if scans show that the cancer has grown but your doctor believes you are still benefiting from treatment and side effects are manageable, you may be able to continue treatment with approval from both your doctor and the study sponsor.

Conditions

This trial is treating people with locally advanced or metastatic urothelial cancer

Eligibility

Inclusion

  • 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

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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Pfizer

Scientific 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

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