RecruitingPhase 2NCT06553885

Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC

A Phase II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic Colorectal Cancer or Hepatocellular Carcinoma


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

40 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial is testing enfortumab vedotin — an antibody-drug conjugate (a targeted drug that delivers chemotherapy directly to cancer cells) — in patients with advanced or metastatic colorectal cancer (CRC) or liver cancer (hepatocellular carcinoma, HCC) whose cancer has progressed after standard treatments. **You may be eligible if...** - You are 18 or older with confirmed advanced colorectal cancer or liver cancer - For CRC: your cancer progressed after 2-3 prior treatment lines including standard chemotherapy drugs - For HCC: your cancer progressed after 1-2 prior treatment lines including immunotherapy or targeted therapy - You are in good health (ECOG ≤1) with adequate blood, liver, and kidney function **You may NOT be eligible if...** - You have active brain metastases requiring steroids - You have previously received enfortumab vedotin or another MMAE-based drug - You have another cancer diagnosed within the last 3 years (with some exceptions) - You have HIV, active hepatitis B or C, significant heart disease, or uncontrolled diabetes - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnfortumab Vedotin

Enfortumab vedotin is a type of prescription medicine known as an antibody-drug conjugate.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06553885


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