← Back to Search

Antibody-drug Conjugate

Enfortumab Vedotin for Colorectal and Liver Cancers

Phase 2

Waitlist Available

Led By Tiago Biachi de Castria, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Participants must have histologically confirmed CRC or HCC that is metastatic or unresectable and have progressive disease or intolerance after standard front-line therapies

ECOG performance status ≤1

Must not have

Currently receiving systemic antimicrobial treatment for active infection at the time of first dose of enfortumab vedotin

Known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called enfortumab vedotin in adults with advanced colorectal cancer or liver cancer who have already received other treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of Enfortumab Vedotin aren't listed here, common ones may include fatigue, hair loss, nausea, skin rash and potential infusion-related reactions. Each patient's experience can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

My colorectal or liver cancer has worsened or returned after my last treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am allergic to enfortumab vedotin or its ingredients.

Select...

I have not had radiotherapy, major surgery, or any cancer treatment within the last 2 weeks.

Select...

I have moderate to severe numbness, tingling, or muscle weakness.

Select...

My cancer has spread to my brain.

Select...

I have previously been in a study for enfortumab vedotin or received similar treatments.

Select...

I have tested positive for hepatitis B.

Select...

I have an active eye infection or corneal ulcer.

Select...

My diabetes is not under control.

Select...

I do not have active hepatitis C or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Progression-free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

0 / 13Eligibility criteria met