Enfortumab Vedotin for Advanced Cancer

Recruiting at 40 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Astellas Pharma Global Development, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1. This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.

Research Team

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Eligibility Criteria

Adults with various advanced or metastatic cancers (like breast, lung, gastric, and head & neck cancer) who have measurable disease and are in good physical condition (ECOG 0-1). They must have normal organ function tests, no recent second malignancies or severe neuropathy, not be on active infection treatment, and without HIV or hepatitis B/C. Prior treatments should be completed at least 2 weeks before the trial.

Inclusion Criteria

I am legally an adult and can sign the consent form.

I am fully active or can carry out light work.

You have a medical condition that can be measured using the RECIST Version 1.1 criteria.

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Exclusion Criteria

I have active hepatitis B or C.

My diabetes has been under control for the last 3 months.

I haven't had cancer treatments like chemotherapy or immunotherapy in the last 2 weeks.

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Treatment Details

Interventions

Enfortumab Vedotin (Antibody-drug conjugate)

Trial OverviewThe study is testing enfortumab vedotin's effectiveness against tumors by looking at response rates and overall survival. For one group (cohort 9), they're also adding pembrolizumab to see if it improves outcomes. Participants will be monitored for how well their tumors respond to these drugs as well as for safety and tolerability.

Participant Groups

9Treatment groups

Experimental Treatment

Group I: Cohort 9: Head and neck squamous cell carcinoma (HNSCC)Experimental Treatment2 Interventions

Participants will receive enfortumab vedotin as an IV infusion on days 1 and 8 of each 21-day cycle. Pembrolizumab will be administered as an IV infusion on day 1 of each 21-day cycle.

Group II: Cohort 8: Esophageal squamous cell carcinoma (ESCC)Experimental Treatment1 Intervention