OncoMatch/Clinical Trials/NCT06553885
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
Is NCT06553885 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Enfortumab Vedotin for metastatic colorectal cancer.
Treatment: Enfortumab Vedotin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Hepatocellular Carcinoma
Biomarker criteria
Allowed: KRAS wild-type
anti EGFR antibody for RAS/RAF wild-type CRC
Allowed: NRAS wild-type
anti EGFR antibody for RAS/RAF wild-type CRC
Allowed: BRAF wild-type
anti EGFR antibody for RAS/RAF wild-type CRC
Disease stage
Metastatic disease required
metastatic or unresectable and have progressive disease or intolerance after standard front-line therapies
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy (fluoropyrimidine, oxaliplatin, irinotecan) — advanced or metastatic CRC
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
Must have received: anti-EGFR antibody — RAS/RAF wild-type CRC
with or without anti EGFR antibody for RAS/RAF wild-type CRC
Must have received: bevacizumab (bevacizumab) — CRC
or bevacizumab unless contraindicated
Must have received: PD-1/PD-L1 immune checkpoint inhibitor — MSI-H CRC
For patients with microsatellite instability high (MSI-H) CRC, previous lines of therapy should include a PD-1/PD-L1 immune checkpoint inhibitor in addition to the chemotherapy agents mentioned above
Must have received: systemic therapy — advanced or metastatic HCC
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.
Must have received: PD-1/PD-L1 immune checkpoint inhibitor — HCC
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.
Must have received: multikinase inhibitor — HCC
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.
Cannot have received: enfortumab vedotin (enfortumab vedotin)
Prior enrollment in an enfortumab vedotin study or prior treatment with other MMAE-based ADCs.
Cannot have received: MMAE-based antibody-drug conjugate
Prior enrollment in an enfortumab vedotin study or prior treatment with other MMAE-based ADCs.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1500/mm3; Platelet count ≥100 × 10^9/L; Hemoglobin ≥9 g/dL
Kidney function
Creatinine clearance (CrCl) ≥30 mL/min as estimated per institutional standards
Liver function
Serum total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN for subjects with Gilbert's disease; ALT and AST ≤2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases; Liver function status should be Child-Pugh (CP) Class A.
Participants must have adequate organ and marrow function as defined below: 1. Absolute neutrophil count (ANC) ≥ 1500/mm3 2. Platelet count ≥100 × 10^9/L 3. Hemoglobin ≥9 g/dL 4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease 5. Creatinine clearance (CrCl) ≥30 mL/min as estimated per institutional standards 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases 7. Liver function status should be Child-Pugh (CP) Class A.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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