NCT07139977

Study of EV for Recurrent Endometrial Carcinoma

Open-Label Phase II Trial of Enfortumab Vedotin in Recurrent or Persistent Endometrial Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: William Bradley · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an open-label, single-arm Phase II trial evaluating the efficacy and safety of enfortumab vedotin monotherapy in up to 12 patients with advanced or metastatic endometrial carcinoma who have progressed after prior chemotherapy and anti-PD-1 or other immunotherapy. Treatment will continue for up to 12 months or until disease progression per RECIST v1.1, unacceptable toxicity, or patient withdrawal. Patients with stable disease or objective response may remain on therapy unless discontinued due to toxicity or patient choice. Those who discontinue treatment for reasons other than progression will be followed for disease status until progression.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Enfortumab Vedotin	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-30
• Completion: 2028-05-31
• First posted: 2025-08-24
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study