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

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-08634404: Concentrate for solution for Infusion.

Enfortumab Vedotin: Powder for concentrate for solution for infusion

Study 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.

Eligibility

Primary outcome measure(s)

• Confirmed Objective Response Rate (ORR) by investigator — 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.
• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 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.
• Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B — 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.

Trial sites (153)

+ 113 more sites — see the full list on the official registry below.

On this site

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