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Monoclonal Antibodies

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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Concentration at the end of infusion (CEOI)

Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Maximum observed concentration (Cmax)

+6 more

Secondary outcome measures

Disease control rate

Duration of Response

Incidence of Anti-Drug Antibody (ADA)

+4 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Seagen Inc.Industry Sponsor

207 Previous Clinical Trials

68,944 Total Patients Enrolled

5 Trials studying Urothelial Cancer

2,400 Patients Enrolled for Urothelial Cancer

Astellas Pharma Global Development, Inc.Lead Sponsor

192 Previous Clinical Trials

120,849 Total Patients Enrolled

4 Trials studying Urothelial Cancer

2,165 Patients Enrolled for Urothelial Cancer

Medical DirectorStudy DirectorAgensys, Inc.

2,777 Previous Clinical Trials

8,063,273 Total Patients Enrolled

3 Trials studying Urothelial Cancer

1,524 Patients Enrolled for Urothelial Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room to accommodate participants in this study?

"This study, which was posted in June of 2014 and last edited November 9th 2022 is not currently soliciting volunteers. Nevertheless, there are 2397 other trials that have open enrolment at the moment."

Answered by AI

What is enfortumab vedotin commonly prescribed to treat?

"Enfortumab vedotin is a pharmacological therapy used to treat metastatic urothelial cancer and other maladies that necessitate therapeutic intervention."

Answered by AI

How many healthcare facilities are currently engaged in this scientific experiment?

"This clinical trial has enlisted 21 medical sites to recruit participants. Notably, these include Aurora's Site US00017, Chapel Hill's Site US00023, and Los Angeles' Site US00012."

Answered by AI

Is this research pioneering or has it been attempted before?

"Since 2014, Seagen Inc. has been researching enfortumab vedotin and have held numerous clinical trials since then. After the initial Phase 1 study with 213 patients in 2014, it was approved for use as a drug. Currently there are 18 active studies involving this medication across 377 cities and 44 nations worldwide."

Answered by AI

Has the FDA sanctioned enfortumab vedotin for use?

"Due to the preliminary nature of this clinical trial, enfortumab vedotin is rated a 1 on our safety scale. This indicates that there is limited evidence backing its efficacy and security."

Answered by AI

What is the targeted sample size for this clinical investigation?

"This research project has since ended its recruitment phase, having first been posted on June 4th 2014 and last updated with new information November 9th 2022. However, there are 2379 other studies related to metastatic urothelial cancer and 18 clinical trials recruiting patients for enfortumab vedotin treatments that are still open to applications."

Answered by AI

What prior research has been done involving enfortumab vedotin?

"At present, there are 18 ongoing clinical trials for enfortumab vedotin with 6 in the final stages of testing. Although most of these studies are situated in Roma and Abruzzo, over 1,300 venues across the world host experiments related to this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4

2014. "A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02091999.