The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
SYD985 powder for concentrate for solution for infusion
Objective Response Rate (ORR)
ORR is defined as the proportion of patients with an assessed best overall response of complete response or partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier.
Time frame: 2 years
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause.
Time frame: 2 years
Number of Participants With Treatment-Emergent Adverse Events (AEs)
AEs will be graded by the investigator as assessed by CTCAE v5.0.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Smilow Cancer Hospital (Yale)
New Haven, Connecticut, United States
MedTrials
Krakow, Poland
St. John of Dukla Oncology Center of Lublin Land
Lublin, Poland
Arkhangelsk Clinical Oncology Center
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Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center
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Regional Oncology Center
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...and 26 more locations