A Phase 2 interventional study of SYD985 in Endometrial Cancer, sponsored by Byondis B.V.. Completed at 36 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by Byondis B.V. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer.
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's enrollment of 64 is close to the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Byondis B.V. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Eligible patients should have progressed on or after 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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SYD985, Intravenous, every 3 weeks (Q3W)
Drug: SYD985
SYD985 powder for concentrate for solution for infusion
Also known as: Trastuzumab vc-seco-DUBA, (vic-)trastuzumab duocarmazine
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.
Time frame: 2 years
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.
Time frame: 2 years
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause.
Time frame: 2 years
Number of Participants With Treatment-Emergent Adverse Events (AEs)
AEs will be graded by the investigator as assessed by CTCAE v5.0.
Time frame: 2 years
A total of 80 participants were screened, out of which 64 patients were enrolled in the study.
| Milestone | SYD985 |
|---|---|
| Started | 64 |
| Full analysis set (all patients who received at least 1 dose of study treatment) | 64 |
| Efficacy analysis set (all patients who had at least one post-baseline tumour evaluation assessment) | 61 |
| Completed | 0 |
| Not completed | 64 |
| Withdrew: Disease progression per recist 1.1 | 37 |
| Withdrew: Disease clinical progression | 7 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Adverse event | 17 |
| Withdrew: Other | 1 |
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.
| Participants | SYD985 |
|---|---|
| Objective Response Rate (ORR) | 20 |
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.
| months | SYD985 |
|---|---|
| Progression-Free Survival (PFS) | 5.6 (4.0 to 7.6) |
OS is defined as the time from date of randomization to death due to any cause.
| months | SYD985 |
|---|---|
| Overall Survival (OS) | 16.3 (11.6 to 20.5) |
AEs will be graded by the investigator as assessed by CTCAE v5.0.
| Participants | SYD985 |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | 51 |
Collected over Adverse events were collected for each participant from the time of signing the main informed consent form (ICF) up to 30 days after the treatment discontinuation visit, up to 2 years 9 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SYD985 | 36/64 (56.3%) | 12/64 (18.8%) | 51/64 (79.7%) |
| Event | SYD985 |
|---|---|
| COVID-19 pneumoniaInfections and infestations | 3/64 |
| AnaemiaBlood and lymphatic system disorders | 2/64 |
| Abdominal herniaGastrointestinal disorders | 1/64 |
| NauseaGastrointestinal disorders | 1/64 |
| Oesophageal haemorrhageGastrointestinal disorders | 1/64 |
| Cardiac failureCardiac disorders | 1/64 |
| Cardiac failure acuteCardiac disorders | 1/64 |
| General physical health deteriorationGeneral disorders | 1/64 |
| Sudden deathGeneral disorders | 1/64 |
| Cervical spinal stenosisMusculoskeletal and connective tissue disorders | 1/64 |
| Event | SYD985 |
|---|---|
| KeratitisEye disorders | 20/64 |
| Dry eyeEye disorders | 18/64 |
| ConjunctivitisEye disorders | 14/64 |
| Skin hyperpigmentationSkin and subcutaneous tissue disorders | 11/64 |
| FatigueGeneral disorders | 9/64 |
| AnaemiaBlood and lymphatic system disorders | 8/64 |
| Infusion related reactionInjury, poisoning and procedural complications | 8/64 |
| Periorbital oedemaEye disorders | 7/64 |
| AlopeciaSkin and subcutaneous tissue disorders | 7/64 |
| LeukopeniaBlood and lymphatic system disorders | 7/64 |
| Age, Continuous(years) | SYD985 |
|---|---|
| Mean | 66.3 ± 7.31 |
| Sex: Female, Male(Participants) | SYD985 |
|---|---|
| Female | 64 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | SYD985 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 64 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | SYD985 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 13 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 48 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | SYD985 |
|---|---|
| South Korea | 7 |
| Singapore | 5 |
| United States | 9 |
| Ukraine | 19 |
| Poland | 4 |
| Serbia | 6 |
| Russia | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2020 to primary completion in Jan 2023, 31 months.
Results were first posted in May 2024, 1 year 4 months after primary completion.
Of 139 phase 2 interventional studies under Endometrial Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 115. This study's 31 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Trastuzumab duocarmazine
Byondis B.V.