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

Trial number:
NCT04205630
Trial phase:
2
Study type:
Targeted therapy
Overall status:
Completed

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

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