SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma

Endometrial Cancer Clinical Trial

Official title: A Single-arm Phase II Trial to Evaluate the Safety and Efficacy of the Antibody-Drug Conjugate (ADC) SYD985 in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Endometrial Carcinoma Who Previously Progressed on or After First Line Platinum-based Chemotherapy

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer.

Clinical Trial Description

This is an open-label, single-arm study in patients with HER2-expressing recurrent, advanced or metastatic endometrial carcinoma. HER2-expression is defined as a 1+, 2+ or 3+ score on immunohistochemistry (IHC) or positive by in situ hybridization (ISH). Eligible patients for this study should have progressed on or after first line platinum-based chemotherapy. Patients who have had two or more lines of chemotherapy for advanced/metastatic disease are not eligible.

Eligible patients will receive SYD985 until disease progression or unacceptable toxicity. Patients who have stopped study treatment for other reasons than disease progression will continue their tumor evaluations in an observation period until disease progression or start of a new anticancer therapy. ;

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT04205630
• Study type: Interventional
• Source: Byondis B.V.
• Status: Completed
• Phase: Phase 2
• Start date: May 28, 2020
• Completion date: April 25, 2023