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

ConditionsUrothelial CancerAdvanced/Metastatic Urothelial CancerUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • PF-08634404

    Biological/Vaccine

    Concentrate for solution for Infusion.

  • Enfortumab Vedotin

    Biological/Vaccine

    Powder for concentrate for solution for infusion

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Confirmed Objective Response Rate (ORR) by investigator

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.

Time frame
Up to approximately 3 years
2

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

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

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

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

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

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

Secondary outcomes

1

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

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.

Time frame
Up to approximately 3 years
2

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

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.

Time frame
Up to approximately 3 years
3

Overall Survival (OS)

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

Time frame
Up to approximately 3 years
4

Number of Participants With Clinical Laboratory Abnormalities

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Astellas Pharma Inc

Collaborator

Source ClinicalTrials.gov
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