Enfortumab Vedotin for Colorectal and Liver Cancers

Recruiting in Palo Alto (17 mi)

Overseen byTiago Biachi de Castria, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This study is a multi-indication, open-label, single-treatment arm, parallel-cohort phase II study of enfortumab vedotin in adult participants with advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC) who have been previously treated with one or more lines of systemic therapy.

Eligibility Criteria

This trial is for adults with advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC) who have already tried at least one systemic therapy. Specific details about inclusion and exclusion criteria are not provided, but typically these would cover health status, prior treatments, and other medical conditions.

Inclusion Criteria

Participants must have an anticipated life expectancy of ≥3 months

Participants must agree to use adequate contraception

My colorectal or liver cancer is spreading and cannot be surgically removed, and it's not responding to standard treatments.

+7 more

Exclusion Criteria

I am on antibiotics for an infection and about to start enfortumab vedotin.

I had a stroke or similar brain event within the last 6 months.

Pregnant women

+11 more

Participant Groups

The study is testing Enfortumab Vedotin in patients with CRC or HCC. It's an open-label phase II trial, meaning everyone knows they're getting the drug, and it's given to see how effective it is after initial treatments have been tried.

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Hepatocellular CarcinomaExperimental Treatment1 Intervention

Enfortumab vedotin at a dose of 1.25 mg/kg will be administered as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of every 28-day cycle.

Group II: Cohort 1: Colorectal CancerExperimental Treatment1 Intervention

Enfortumab vedotin at a dose of 1.25 mg/kg will be administered as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of every 28-day cycle.

Enfortumab Vedotin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Padcev for: