SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma
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|ClinicalTrials.gov Identifier: NCT04205630|
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: SYD985||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
SYD985, Intravenous, every 3 weeks (Q3W)
SYD985 powder for concentrate for solution for infusion
- 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.
- 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.
- 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.
- Incidence of Treatment-Emergent Adverse Events (AEs) [ Time Frame: 2 years ]AEs will be graded by the investigator as assessed by CTCAE v5.0
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
|Contact: Maaike Hendriks, MSc||+31 (0)24 679 email@example.com|
|Study Director:||Maaike Hendriks, MSc||Byondis B.V., The Netherlands|