SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma
NCT ID: NCT04205630
Last Updated: 2024-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2020-05-28
2023-04-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SYD985
SYD985, Intravenous, every 3 weeks (Q3W)
SYD985
SYD985 powder for concentrate for solution for infusion
Interventions
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SYD985
SYD985 powder for concentrate for solution for infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* History of infusion-related reactions and/or hypersensitivity to trastuzumab;
* History of keratitis;
* Severe, uncontrolled systemic disease at screening;
* Left Ventricular Ejection Fraction (LVEF) \< 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab;
* History of clinically significant cardiovascular disease;
* Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;
* History or presence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
18 Years
FEMALE
No
Sponsors
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Byondis B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Byondis B.V., The Netherlands
Locations
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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
Arkhangelsk, , Russia
Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center
Chelyabinsk, , Russia
Regional Oncology Center
Irkutsk, , Russia
Clinical Oncology Center
Omsk, , Russia
Orenburg Regional Clinical Oncology Center
Orenburg, , Russia
Oncology Center of Moskovskiy District
Saint Petersburg, , Russia
Private Medical Institution "EVROMEDSERVIS"
Saint Petersburg, , Russia
AV Medical Group
Saint Petersburg, , Russia
Oncology Center #2
Sochi, , Russia
Tambov Regional Oncological Clinical Center
Tambov, , Russia
Republican Clinical Oncology Center
Ufa, , Russia
Volgograd Regional Clinical Oncology Center
Volgograd, , Russia
National Cancer Research Center
Belgrade, , Serbia
Oncology Institute of Vojvodina (IOV), Clinic of Surgical Oncology, Department of Gynecology
Kamenitz, , Serbia
Clinical Center Nis, Clinic of Oncology
Niš, , Serbia
National University Hospital, Department of Hematology-Oncology
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council
Cherkasy, , Ukraine
Chernivtsi Regional Clinical Oncology Center
Chernivtsi, , Ukraine
"City Clinical Hospital #4" under Dnipro City Council
Dnipro, , Ukraine
Prykarpattia Clinical Oncology Center
Ivano-Frankivsk, , Ukraine
State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences
Kharkiv, , Ukraine
Communal Non-profit enterprise "Regional Center of Oncology"
Kharkiv, , Ukraine
Medical Center "Verum"
Kyiv, , Ukraine
Odesa Regional Clinical Hospital
Odesa, , Ukraine
Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center
Ternopil, , Ukraine
Podilla Regional Oncology Center
Vinnytsia, , Ukraine
Medical Center ONCOLIFE LLC
Zaporizhzhia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SYD985.003
Identifier Type: -
Identifier Source: org_study_id
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