C6461006 - 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.

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523523-21-00

Enrollment

Registered

2026-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Urothelial Cancer

Brief summary

Cohort A: Confirmed ORR by investigator, AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention, Cohort B: DLTs during the DLT-observation period (Cycle 1) (Part 1), AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention(s), Confirmed ORR by investigator

Detailed description

DoR by investigator, PFS by investigator, OS, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), Predose and postdose concentrations of PF-08634404, Incidence of ADA against PF-08634404

Interventions

DRUGPadcev 30 mg powder for concentrate for solution for infusion

DRUGPF-08634404

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cohort A: Confirmed ORR by investigator, AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention, Cohort B: DLTs during the DLT-observation period (Cycle 1) (Part 1), AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention(s), Confirmed ORR by investigator	—

Measure

Time frame

—

Secondary

Measure	Time frame
DoR by investigator, PFS by investigator, OS, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), Predose and postdose concentrations of PF-08634404, Incidence of ADA against PF-08634404	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 30, 2026