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

Phase 2

Completed

• Conditions: Endometrial Cancer
• Interventions: Drug: SYD985

• Registration Number: NCT04205630
• Lead Sponsor: Byondis B.V.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2020-05-28
• Primary Completion: 2023-01-26
• Study Completion: 2023-04-25
• Results First Submitted: 2024-04-02
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-29
• Last Update Submitted: 2024-05-29
• Results First Posted: 2024-05-30
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYD985	SYD985	SYD985, Intravenous, every 3 weeks (Q3W)

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (AEs)	2 years	AEs will be graded by the investigator as assessed by CTCAE v5.0.
Progression-Free Survival (PFS)	2 years	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.
Overall Survival (OS)	2 years	OS is defined as the time from date of randomization to death due to any cause.

Trial Locations

Locations (36)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center; 🇷🇺 Chelyabinsk, Russian Federation

Private Medical Institution "EVROMEDSERVIS"; 🇷🇺 Saint Petersburg, Russian Federation

Republican Clinical Oncology Center; 🇷🇺 Ufa, Russian Federation

Chernivtsi Regional Clinical Oncology Center; 🇺🇦 Chernivtsi, Ukraine

Medical Center "Verum"; 🇺🇦 Kyiv, Ukraine

Odesa Regional Clinical Hospital; 🇺🇦 Odesa, Ukraine

St. John of Dukla Oncology Center of Lublin Land; 🇵🇱 Lublin, Poland

National University Hospital, Department of Hematology-Oncology; 🇸🇬 Singapore, Singapore

Communal Non-profit enterprise "Regional Center of Oncology"; 🇺🇦 Kharkiv, Ukraine

Podilla Regional Oncology Center; 🇺🇦 Vinnytsia, Ukraine

Oncology Center of Moskovskiy District; 🇷🇺 St. Petersburg, Russian Federation

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore

Smilow Cancer Hospital (Yale); 🇺🇸 New Haven, Connecticut, United States

Orenburg Regional Clinical Oncology Center; 🇷🇺 Orenburg, Russian Federation

MedTrials; 🇵🇱 Kraków, Poland

Arkhangelsk Clinical Oncology Center; 🇷🇺 Arkhangelsk, Russian Federation

Regional Oncology Center; 🇷🇺 Irkutsk, Russian Federation

Volgograd Regional Clinical Oncology Center; 🇷🇺 Volgograd, Russian Federation

Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council; 🇺🇦 Cherkasy, Ukraine

"City Clinical Hospital #4" under Dnipro City Council; 🇺🇦 Dnipro, Ukraine

Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center; 🇺🇦 Ternopil, Ukraine

Clinical Oncology Center; 🇷🇺 Omsk, Russian Federation

Oncology Center #2; 🇷🇺 Sochi, Russian Federation

Tambov Regional Oncological Clinical Center; 🇷🇺 Tambov, Russian Federation

National Cancer Research Center; 🇷🇸 Belgrade, Serbia

Clinical Center Nis, Clinic of Oncology; 🇷🇸 Nis, Serbia

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

AV Medical Group; 🇷🇺 St. Petersburg, Russian Federation

Oncology Institute of Vojvodina (IOV), Clinic of Surgical Oncology, Department of Gynecology; 🇷🇸 Sremska Kamenica, Serbia

Medical Center ONCOLIFE LLC; 🇺🇦 Zaporizhzhia, Ukraine