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Antibody-drug Conjugate

Cohort 2: Hepatocellular Carcinoma for Colorectal Cancer

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 with CRC (cohort 1): Participants must have had progressive disease or intolerance after at least 2 but no more than 3 prior lines of systemic therapy in advanced or metastatic setting. Prior lines of therapy should include fluoropyrimidine (5-fluorouracil or capecitabine), oxaliplatin, and irinotecan with or without anti EGFR antibody for RAS/RAF wild-type CRC or bevacizumab unless contraindicated. For patients with microsatellite instability high (MSI-H) CRC, previous lines of therapy should include a PD-1/PD-L1 immune checkpoint inhibitor in additional to the chemotherapy agents mentioned above. Adjuvant chemotherapy with radiographic progression greater than 12 months after the last dose is not considered as a line of therapy.
Participants with HCC (cohort 2): Participants must have had progressive disease or intolerance after at least 1 but no more than 2 prior lines of systemic therapy in advanced or metastatic setting. Prior lines of therapy should include a PD-1/PD-L1 immune checkpoint inhibitor or a multikinase inhibitor, which was administered either alone or in combination.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

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.

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

Timeline

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)

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.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
553 Previous Clinical Trials
143,719 Total Patients Enrolled
Astellas Pharma IncIndustry Sponsor
695 Previous Clinical Trials
233,256 Total Patients Enrolled
Tiago Biachi de Castria, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
~27 spots leftby Sep 2029
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