Clinical Trials /

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

NCT04205630

Description:

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

Related Conditions:
  • Endometrial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: SYD985.003
  • NCT ID: NCT04205630

Conditions

  • Endometrial Cancer

Interventions

DrugSynonymsArms
SYD985Trastuzumab vc-seco-DUBA, (vic-)trastuzumab duocarmazineSYD985

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
SYD985ExperimentalSYD985, Intravenous, every 3 weeks (Q3W)
  • SYD985

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:2 years
Safety Issue:
Description: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

Measure:Progression-Free Survival (PFS)
Time Frame:2 years
Safety Issue:
Description: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.
Measure:Overall Survival (OS)
Time Frame:2-year overall survival
Safety Issue:
Description:Overall survival is defined as the time from date of randomization to death due to any cause.
Measure:Incidence of Treatment-Emergent Adverse Events (AEs)
Time Frame:2 years
Safety Issue:
Description:AEs will be graded by the investigator as assessed by CTCAE v5.0

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Byondis B.V.

Last Updated

July 1, 2020