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

Endometrial Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205630
• Other study ID #: SYD985.003
• Status: Completed
• Phase: Phase 2
• Start date: May 28, 2020
• Est. completion date: April 25, 2023

Study information

• Verified date: May 2024
• Source: Byondis B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 25, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• 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;

Exclusion Criteria:

• Current or previous use of a prohibited medication as listed in the protocol;
• 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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• SYD985
SYD985 powder for concentrate for solution for infusion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Poland	MedTrials	Kraków
Poland	St. John of Dukla Oncology Center of Lublin Land	Lublin
Russian Federation	Arkhangelsk Clinical Oncology Center	Arkhangelsk
Russian Federation	Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center	Chelyabinsk
Russian Federation	Regional Oncology Center	Irkutsk
Russian Federation	Clinical Oncology Center	Omsk
Russian Federation	Orenburg Regional Clinical Oncology Center	Orenburg
Russian Federation	Private Medical Institution "EVROMEDSERVIS"	Saint Petersburg
Russian Federation	Oncology Center #2	Sochi
Russian Federation	AV Medical Group	St. Petersburg
Russian Federation	Oncology Center of Moskovskiy District	St. Petersburg
Russian Federation	Tambov Regional Oncological Clinical Center	Tambov
Russian Federation	Republican Clinical Oncology Center	Ufa
Russian Federation	Volgograd Regional Clinical Oncology Center	Volgograd
Serbia	National Cancer Research Center	Belgrade
Serbia	Clinical Center Nis, Clinic of Oncology	Nis
Serbia	Oncology Institute of Vojvodina (IOV), Clinic of Surgical Oncology, Department of Gynecology	Sremska Kamenica
Singapore	National Cancer Centre Singapore	Singapore
Singapore	National University Hospital, Department of Hematology-Oncology	Singapore
Ukraine	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	Communal Non-profit enterprise "Regional Center of Oncology"	Kharkiv
Ukraine	State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences	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
United States	Smilow Cancer Hospital (Yale)	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Byondis B.V.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Poland,  Russian Federation,  Serbia,  Singapore,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years
Secondary	Overall Survival (OS)	OS is defined as the time from date of randomization to death due to any cause.	2 years
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs)	AEs will be graded by the investigator as assessed by CTCAE v5.0.	2 years