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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04205630
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: SYD985 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: SYD985
SYD985, Intravenous, every 3 weeks (Q3W)
Drug: SYD985
SYD985 powder for concentrate for solution for infusion
Other Names:
  • Trastuzumab vc-seco-DUBA
  • (vic-)trastuzumab duocarmazine




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 2 years ]
    Objective response rate 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 :
  1. Progression-Free Survival (PFS) [ Time Frame: 2 years ]
    Progression-free survival 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. Overall Survival (OS) [ Time Frame: 2-year overall survival ]
    Overall survival is defined as the time from date of randomization to death due to any cause.

  3. Incidence of Treatment-Emergent Adverse Events (AEs) [ Time Frame: 2 years ]
    AEs will be graded by the investigator as assessed by CTCAE v5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205630


Contacts
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Contact: Maaike Hendriks, MSc +31 (0)24 679 5100 clinicaltrials@byondis.com

Locations
Show Show 36 study locations
Sponsors and Collaborators
Byondis B.V.
Investigators
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Study Director: Maaike Hendriks, MSc Byondis B.V., The Netherlands
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Responsible Party: Byondis B.V.
ClinicalTrials.gov Identifier: NCT04205630    
Other Study ID Numbers: SYD985.003
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents