Clinical trial NCT04205630: SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Lead sponsor: Byondis B.V.
Sponsor class: INDUSTRY
First posted: 2019-12-19
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Smilow Cancer Hospital (Yale)
state: Connecticut
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Kraków
country: Poland
facility: MedTrials
city: Lublin
country: Poland
facility: St. John of Dukla Oncology Center of Lublin Land
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncology Center
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center
city: Irkutsk
country: Russian Federation
facility: Regional Oncology Center
city: Omsk
country: Russian Federation
facility: Clinical Oncology Center
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Oncology Center
city: Saint Petersburg
country: Russian Federation
facility: Private Medical Institution "EVROMEDSERVIS"
city: Sochi
country: Russian Federation
facility: Oncology Center #2
city: St. Petersburg
country: Russian Federation
facility: Oncology Center of Moskovskiy District
city: St. Petersburg
country: Russian Federation
facility: AV Medical Group
city: Tambov
country: Russian Federation
facility: Tambov Regional Oncological Clinical Center
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Center
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Center
city: Belgrade
country: Serbia
facility: National Cancer Research Center
city: Nis
country: Serbia
facility: Clinical Center Nis, Clinic of Oncology
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina (IOV), Clinic of Surgical Oncology, Department of Gynecology
city: Singapore
country: Singapore
facility: National University Hospital, Department of Hematology-Oncology
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Oncology Center
city: Dnipro
country: Ukraine
facility: "City Clinical Hospital #4" under Dnipro City Council
city: Ivano-Frankivsk
country: Ukraine
facility: Prykarpattia Clinical Oncology Center
city: Kharkiv
country: Ukraine
facility: State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences
city: Kharkiv
country: Ukraine
facility: Communal Non-profit enterprise "Regional Center of Oncology"
city: Kyiv
country: Ukraine
facility: Medical Center "Verum"
city: Odesa
country: Ukraine
facility: Odesa Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center
city: Vinnytsia
country: Ukraine
facility: Podilla Regional Oncology Center
city: Zaporizhzhia
country: Ukraine
facility: Medical Center ONCOLIFE LLC
Study officials:
affiliation: Byondis B.V., The Netherlands
name: Clinical Development
role: STUDY_DIRECTOR
References: