Recruiting

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

# NCT04205630 Trial phase: 2 Study type: targeted

Study Start Date

May, 2020

Scientific 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

Summary

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

Main - Females with histologically confirmed recurrent, advanced or metastatic endometrial carcinoma - Eligible patients should have progressed on or after first line platinum-based chemotherapy for advanced/metastatic endometrial cancer. Patients who have had two or more lines of chemotherapy for advanced/metastatic disease are not eligible, taking into account the following: - Patients may have received up to one additional line of chemotherapy if given in the neoadjuvant or adjuvant setting. If such treatment was completed less than 6 months prior to the current tumor recurrence or progression it is to be considered first-line treatment; - No more than one line of non-cytotoxic systemic cancer therapy (such as immunotherapy, trastuzumab or protein kinase inhibitors) is allowed. - HER2 tumor expression defined as a 1+, 2+ or 3+ score on IHC or positive by ISH - At least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumours (RECIST version 1.1); - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

Study Design

Primary purpose: Treatment , Allocation: N/A , Intervention model: Single Group Assignment , Masking: None (Open Label)

Conditions

Endometrial Cancer

Other Study ID Numbers

SYD985.003

Locations

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