enfortumab vedotin for Urothelial Cancer

Phase 1

Waitlist Available

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug, enfortumab vedotin, for safety and effectiveness in treating subjects with metastatic urothelial cancer and other malignant solid tumors.

Eligible Conditions

Urothelial Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Disease control rate

Duration of Response

Objective response rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part C enfortumab vedotin CPI Treated ExpansionExperimental Treatment1 Intervention

Subjects will receive a single 30 minute IV infusion of enfortumab vedotin at the preliminary RP2D once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8 and 15). A cycle is 4 weeks. Subjects will continue treatment until disease progression, intolerability of enfortumab vedotin, Investigator decision or consent withdrawal.

Group II: Part B enfortumab vedotin Renal Insufficiency ExpansionExperimental Treatment1 Intervention

Subjects will receive a single 30 minute IV infusion of enfortumab vedotin at a dose level below and escalated up to the preliminary RP2D once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8 and 15) until disease progression, intolerability of the investigational product or consent withdrawal. A cycle is 4 weeks.

Group III: Part B enfortumab vedotin Ovarian Cancer ExpansionExperimental Treatment1 Intervention

Subjects will receive a single 30 minute IV infusion of enfortumab vedotin at the preliminary RP2D once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8 and 15) until disease progression, intolerability of the investigational product or consent withdrawal. A cycle is 4 weeks.

Group IV: Part B enfortumab vedotin NSCLC ExpansionExperimental Treatment1 Intervention

Group V: Part A enfortumab vedotin Dose Escalation (Dose Levels 1-4)Experimental Treatment1 Intervention

All subjects will receive a single 30 minute intravenous (IV) infusion of enfortumab vedotin once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

enfortumab vedotin

2014

Completed Phase 1

~220

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