Study of EV for Recurrent Endometrial Carcinoma

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
William Bradley
Study ID
NCT07139977
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Enfortumab Vedotin — DRUG
    Enfortumab vedotin is an ADC comprised of a fully human IgG1Κ antibody conjugated to the microtubule-disrupting agent MMAE via a protease-cleavable linker. Enfortumab vedotin is thought to induce anti-tumor activity by binding to the nectin-4 protein on the surface of cancer cells, leading to internalization, proteolytic cleavage of the linker, and intracellular release of MMAE that subsequently disrupts tubulin polymerization and leads to mitotic arrest and apoptosis of the tumor cell.

Study Details

This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Patients will be treated for up to one year and followed over time to monitor their health and response to the treatment.

Key Dates

Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enfortumab vedotin: 1.25 mg/kg on days 1,8, and 15 of the 28 day cycle
    Single arm trial

Primary Outcome Measure

Estimate the overall response rate (ORR) [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Memorial Lutheran HospitalMilwaukeeWisconsin53226
Sukanya Skandarajah
4148055337
Subana Paul
4148058594
William H Bradley, MD (PRINCIPAL_INVESTIGATOR)

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