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A Single-arm Phase II Trial to Evaluate the Safety and Efficacy of the Antibody-Drug Conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) in Patients With HER2-Expressing Endometrial Carcinoma Who Previously Progressed on or After First-Line Platinum-based Chemotherapy (SYD985.003) will enroll approximately 60 patients in up to 40 clinical sites in the United States Europe and Asia-Pacific. The first patients started treatment at Severance Hospital Yonsei University Health System South Korea where Associate Professor Jung-Yun Lee M.D. Ph.D. is the principal investigator.
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In the U.S. renowned endometrial cancer expert Alessandro Santin M.D. Yale Cancer Center professor of obstetrics gynecology and reproductive sciences will serve as principal investigator for the Yale study site. About 20 years ago Professor Santin’s lab discovered the connection between some types of an aggressive form of endometrial cancer known as Uterine Serous Carcinoma (USC) and HER2 expression. In 2018 preliminary data from Professor Santin’s Phase II study (1) led to the inclusion of the chemotherapy-trastuzumab combination for new treatment of women with HER2-positive USC in the National Comprehensive Cancer Network (NCCN) guidelines. Recently Clinical Cancer Research published the final results of this same study (2) which confirmed trastuzumab with chemotherapy improves survival rates for women with USC whose tumors expressed high levels of the HER2 protein.
“My team and I are excited to participate in the Phase II study of the investigational antibody-drug conjugate [vic-]trastuzumab duocarmazine in HER2-expressing advanced endometrial cancer” said Professor Santin. “We had the opportunity to study the potential of SYD985 in our preclinical models for endometrial cancer and were impressed by its potential. This ADC combines the ‘double punch’ of anti-HER2 monoclonal antibody trastuzumab with a powerful duocarmycin-based cytotoxin – a combination that could prove beneficial for patients whose disease has progressed.”
[Vic-]trastuzumab duocarmazine (SYD985) is Byondis’ most advanced ADC targeting a range of HER2-positive cancers including breast and endometrial cancer. Previously the U.S. Food & Drug Administration granted SYD985 fast track designation based on promising data from heavily pre-treated last-line HER2-positive metastatic breast cancer patients participating in a two-part Phase I clinical trial (SYD985.001).
“As we near the completion of enrollment in our Phase III study of SYD985 in metastatic HER2- positive breast cancer we are pleased to examine its possible contribution to improving patient outcome in advanced endometrial cancer another difficult disease with unmet need” said Byondis CEO Marco Timmers Ph.D.
