Metastatic Colorectal CancerPhase 2NCT06553885
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
A Phase 2 study testing Enfortumab Vedotin in people with Metastatic Colorectal Cancer and Hepatocellular Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Hepatocellular Carcinoma
- What is being tested?
- Enfortumab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
- 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
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- ECOG performance status ≤1
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥100 × 109/L
- Hemoglobin ≥9 g/dL
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease
- Creatinine clearance (CrCl) ≥30 mL/min as estimated per institutional standards
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases
- Liver function status should be Child-Pugh (CP) Class A.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Cheyenne Schneider, 813-745-5166, Cheyenne.Schneider@moffitt.org
Tiago Biachi de Castria, MD, PhD
About this study
Official title: A Phase II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic Colorectal Cancer or Hepatocellular Carcinoma
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.
- Being tested
- Enfortumab Vedotin
- Keywords
- Nectin-4, Antibody-drug conjugate, Enfortumab, Colorectal, Hepatocellular carcinoma
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfortumab VedotinDrug
Also called PADCEV
Enfortumab vedotin is a type of prescription medicine known as an antibody-drug conjugate.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Colorectal Cancer | Experimental | 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. Receives: Drug: Enfortumab Vedotin |
| Cohort 2: Hepatocellular Carcinoma | Experimental | 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. Receives: Drug: Enfortumab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The ORR is defined as the proportion of evaluable patients with confirmed CR or PR according to RECIST v1.1.
Measured: Up to 3 years
Secondary outcomes (3)
Duration of Response (DOR)
The DOR is defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1) or to death due to any cause, whichever comes first.
Measured: Up to 3 years
Progression-free Survival (PFS)
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST v1.1), or to death due to any cause, whichever comes first.
Measured: Up to 3 years
Overall Survival (OS)
OS is defined as the time from start of study treatment to date of death due to any cause.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Apr 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Tiago Biachi de Castria, MD, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553885
- Sponsor's protocol ID
- MCC-23188
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic Colorectal Cancer or Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06553885
- Acronym / sponsor ID
- MCC-23188
- Keywords
- Nectin-4, Antibody-drug conjugate, Enfortumab, Colorectal, Hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Colorectal Cancer | Experimental | Drug: Enfortumab VedotinEnfortumab 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. |
| Cohort 2: Hepatocellular Carcinoma | Experimental | Drug: Enfortumab VedotinEnfortumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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 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.
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enfortumab VedotinAlso: PADCEVEnfortumab vedotin is a type of prescription medicine known as an antibody-drug conjugate. | Drug | Cohort 1: Colorectal Cancer, Cohort 2: Hepatocellular Carcinoma |
Primary outcome
Overall response rate (ORR)
Time frame: Up to 3 years
The ORR is defined as the proportion of evaluable patients with confirmed CR or PR according to RECIST v1.1.
3 secondary outcomes
Duration of Response (DOR)
Time frame: Up to 3 years
Progression-free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiago Biachi de Castria, MD, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enfortumab Vedotin in people with Metastatic Colorectal Cancer and Hepatocellular Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheyenne Schneider (813-745-5166, Cheyenne.Schneider@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.