Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06553885
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enfortumab Vedotin — DRUG
    Enfortumab vedotin is a type of prescription medicine known as an antibody-drug conjugate.

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Colorectal Cancer
    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.
  • Experimental: Cohort 2: Hepatocellular Carcinoma
    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.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Cheyenne Schneider
[email protected]
813-745-5166
Tiago Biachi de Castria, MD, PhD (PRINCIPAL_INVESTIGATOR)
Iman Imanirad, MD (SUB_INVESTIGATOR)
Dae Won Kim, MD (SUB_INVESTIGATOR)
Richard D Kim, MD (SUB_INVESTIGATOR)
Allan Lima Pereira, MD, PhD (SUB_INVESTIGATOR)
Jonathan Strosberg, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Moffitt Cancer Center· Tampa, FL

Related Studies