Actively Recruiting
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
40
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed metastatic or unresectable colorectal cancer or hepatocellular carcinoma with progressive disease or intolerance after prior systemic therapies
- For colorectal cancer: 2 to 3 prior lines of systemic therapy including specific chemotherapies and targeted agents
- For hepatocellular carcinoma: 1 to 2 prior lines of systemic therapy including immune checkpoint inhibitors or multikinase inhibitors
- Measurable disease according to RECIST v1.1
- Disease progression or recurrence during or after most recent therapy
- ECOG performance status of 0 or 1
- Adequate organ and marrow function including specific blood count and liver/kidney function criteria
- Child-Pugh Class A liver function
- Availability of tumor tissue samples prior to treatment
- Expected life expectancy of at least 3 months
- Agreement to use adequate contraception during and for 4 months after study participation
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Radiotherapy, major surgery, chemotherapy, biologics, investigational agents, or immunotherapy not completed at least 2 weeks prior to first study dose
- Ongoing sensory or motor neuropathy Grade 2 or higher
- Clinically significant toxicity Grade 2 or higher from prior treatment
- Active central nervous system metastases unless stable and meeting specific criteria
- Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates
- History of another malignancy within 3 years, except certain low-risk cancers
- Active infections requiring systemic antimicrobial treatment at first dose
- Positive hepatitis B surface antigen or core antibody without appropriate antiviral prophylaxis
- Active hepatitis C or HIV infection unless treated and with sustained virologic response
- Recent serious cardiovascular events within 6 months
- Known hypersensitivity to enfortumab vedotin or its components
- Active keratitis or corneal ulcerations unless adequately treated
- Uncontrolled diabetes defined by specific hemoglobin A1c levels with symptoms
- Uncontrolled tumor-related bone pain or impending spinal cord compression
- Psychiatric or social conditions limiting study compliance
- Pregnant or breastfeeding women due to potential risks of the study drug
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
C
Cheyenne Schneider
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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