Endometrial CancerPhase 2NCT04205630
SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma
A Phase 2 study testing SYD985 in people with Endometrial Cancer, run by Byondis B.V. at 36 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- SYD985
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 28 May 2020to 25 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
Russia12 sites
Arkhangelsk Clinical Oncology Center
Arkhangelsk, 163045
Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center
Chelyabinsk, 454087
Regional Oncology Center
Irkutsk, 664035
Clinical Oncology Center
Omsk, 644013
Orenburg Regional Clinical Oncology Center
Orenburg, 460021
Oncology Center of Moskovskiy District
Saint Petersburg, 196247
Private Medical Institution "EVROMEDSERVIS"
Saint Petersburg, 196603
AV Medical Group
Saint Petersburg, 197082
Oncology Center #2
Sochi, 354057
Tambov Regional Oncological Clinical Center
Tambov, 392013
Republican Clinical Oncology Center
Ufa, 450054
Volgograd Regional Clinical Oncology Center
Volgograd, 400138
Ukraine11 sites
Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council
Cherkasy, 18099
Chernivtsi Regional Clinical Oncology Center
Chernivtsi, 58013
"City Clinical Hospital #4" under Dnipro City Council
Dnipro, 49102
Prykarpattia Clinical Oncology Center
Ivano-Frankivsk, 76018
State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences
Kharkiv, 61024
Communal Non-profit enterprise "Regional Center of Oncology"
Kharkiv, 61070
Medical Center "Verum"
Kyiv, 3039
Odesa Regional Clinical Hospital
Odesa, 65025
Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center
Ternopil, 46023
Podilla Regional Oncology Center
Vinnytsia, 21029
Medical Center ONCOLIFE LLC
Zaporizhzhya, 69059
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si, 13605
Seoul National University Hospital
Seoul, 3080
Severance Hospital, Yonsei University Health System
Seoul, 3722
Samsung Medical Center
Seoul, 6351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591
Serbia3 sites
National Cancer Research Center
Belgrade, 11000
Oncology Institute of Vojvodina (IOV), Clinic of Surgical Oncology, Department of Gynecology
Kamenitz, 21204
Clinical Center Nis, Clinic of Oncology
Niš, 18000
Poland2 sites
MedTrials
Krakow, 30-820
St. John of Dukla Oncology Center of Lublin Land
Lublin, 20-090
Singapore2 sites
National University Hospital, Department of Hematology-Oncology
Singapore, 119074
National Cancer Centre Singapore
Singapore, 169610
United States1 site
Smilow Cancer Hospital (Yale)
New Haven, Connecticut, 06520-8063
About this study
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
The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- SYD985
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYD985Drug
Also called Trastuzumab vc-seco-DUBA, (vic-)trastuzumab duocarmazine
SYD985 powder for concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| SYD985 | Experimental | SYD985, Intravenous, every 3 weeks (Q3W) Receives: Drug: SYD985 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause.
Measured: 2 years
Number of Participants With Treatment-Emergent Adverse Events (AEs)
AEs will be graded by the investigator as assessed by CTCAE v5.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start28 May 2020
- Primary completion26 Jan 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Byondis B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Study director, Byondis B.V., The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205630
- Sponsor's protocol ID
- SYD985.003
- Status last verified
- May 2024
- First submitted
- 12 Dec 2019
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04205630
- Acronym / sponsor ID
- SYD985.003
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Byondis B.V.Industry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYD985 | Experimental | Drug: SYD985SYD985, Intravenous, every 3 weeks (Q3W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYD985Also: Trastuzumab vc-seco-DUBA, (vic-)trastuzumab duocarmazineSYD985 powder for concentrate for solution for infusion | Drug | SYD985 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 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.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development study director
Byondis B.V., The Netherlands
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYD985 in people with Endometrial Cancer, run by Byondis B.V. at 36 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Russia, Ukraine, South Korea, Serbia, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.