Phase 2 Study of Enfortumab Vedotin for Advanced Colorectal Cancer or Liver Cancer
This study is testing a medicine called enfortumab vedotin in adults with advanced or metastatic (spread to other parts of the body) colorectal cancer (CRC) or hepatocellular carcinoma (HCC), which is a type of liver cancer. You might be able to join if your cancer has progressed or you couldn't tolerate standard treatments. Enfortumab vedotin is an antibody-drug conjugate, which means it's designed to deliver a drug directly to cancer cells. Researchers will be looking at how many participants respond to the treatment, measured over up to three years. This study is currently recruiting about 40 participants.
- Study design
- This is a Phase 2 study, meaning it's an early-stage study to see if the treatment is effective and safe. It's an open-label study, so both you and your doctors will know you are receiving enfortumab vedotin.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of the study, overall response rate, will be measured for up to 3 years.
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NCT06553885
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
Recruiting
PHASE2Ages 18+InterventionalTreatmentH. Lee Moffitt Cancer Center and Research InstituteInvestigator-initiated
~40 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Enfortumab Vedotin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over Up to 3 years
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Tiago Biachi de Castria, MD, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Participants must have histologically confirmed CRC or HCC that is metastatic or unresectable and have progressive disease or intolerance after standard front-line therapies as defined below:
Participants must have measurable disease according to RECIST v1.1. Lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.
Participants must have had progression or recurrence of CRC or HCC during or following receipt of most recent therapy.
Legally an adult according to local regulation at the time of signing informed consent, and minimum age of 18 years
ECOG performance status ≤1
Participants must have adequate organ and marrow function as defined below:
Tumor tissue samples must be available for submission prior to study treatment.
Participants must have an anticipated life expectancy of ≥3 months as assessed by the investigator.
The effects of enfortumab vedotin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 4 months after the last dose. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Radiotherapy or major surgery or chemotherapy, biologics, investigational agents, and/or immunotherapy that is not completed 2 weeks prior to first dose of study drug.
Ongoing sensory or motor neuropathy Grade ≥2. Ongoing clinically significant toxicity (Grade 2 or higher) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
Active central nervous system (CNS) metastases. Participants with treated CNS metastases are permitted on study if all the following are true: i. CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis ii. If requiring steroid treatment for CNS metastases, the patient is on a stable dose ≤20 mg/day of prednisone or equivalent for at least 2 weeks iii. Participant does not have leptomeningeal disease
Prior enrollment in an enfortumab vedotin study or prior treatment with other MMAE-based ADCs.
History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Participants with nonmelanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
Patients with a positive hepatitis B surface antigen and/or antihepatitis B core antibody. Patients with a negative polymerase chain reaction (PCR) assay (HBV DNA is less than 10 IU/ml) are permitted with appropriate antiviral prophylaxis.
Active hepatitis C infection or known human immunodeficiency virus (HIV) infection. Patients who have been treated for hepatitis C infection are permitted if they have negative HCV RNA test (less than 15 IU/ml) and have documented sustained virologic response of ≥12 weeks.
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of enfortumab vedotin.
Known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20)
Participants with active keratitis or corneal ulcerations. Patients with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator.
Participants with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7-8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
Participants with uncontrolled tumor-related bone pain or impending spinal cord compression, uncontrolled intercurrent illness, psychiatric illness/social situations that would limit compliance with study requirements or other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.
Pregnant women are excluded from this study because enfortumab vedotin is an antibody-drug conjugate agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with enfortumab vedotin. Breastfeeding should be discontinued if the mother is treated with EV, and for 3 weeks after the last dose.
What this trial measures
- Overall response rate (ORR)Up to 3 years
The ORR is defined as the proportion of evaluable patients with confirmed CR or PR according to RECIST v1.1.