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
Scientific title
Summary
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;