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

NCT04205630 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SYD985.003
• Study Type: interventional
• Target: 64
• Locations: 7 countries
• Sites: 36

Brief Summary

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

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  2 years

• Overall Survival (OS)

  2 years

• Number of Participants With Treatment-Emergent Adverse Events (AEs)

  2 years

Study Arms (1)

SYD985

EXPERIMENTAL

SYD985, Intravenous, every 3 weeks (Q3W)

Drug: SYD985

Interventions

SYD985 DRUG

SYD985 powder for concentrate for solution for infusion

Also known as: Trastuzumab vc-seco-DUBA, (vic-)trastuzumab duocarmazine

SYD985

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Byondis B.V.: lead

Study Sites (36)

Smilow Cancer Hospital (Yale)

New Haven, Connecticut, 06520-8063, United States

Location

MedTrials

Krakow, 30-820, Poland

Location

St. John of Dukla Oncology Center of Lublin Land

Lublin, 20-090, Poland

Location

Arkhangelsk Clinical Oncology Center

Arkhangelsk, 163045, Russia

Location

Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center

Chelyabinsk, 454087, Russia

Location

Regional Oncology Center

Irkutsk, 664035, Russia

Location

Clinical Oncology Center

Omsk, 644013, Russia

Location

Orenburg Regional Clinical Oncology Center

Orenburg, 460021, Russia

Location

Oncology Center of Moskovskiy District

Saint Petersburg, 196247, Russia

Location

Private Medical Institution "EVROMEDSERVIS"

Saint Petersburg, 196603, Russia

Location

AV Medical Group

Saint Petersburg, 197082, Russia

Location

Oncology Center #2

Sochi, 354057, Russia

Location

Tambov Regional Oncological Clinical Center

Tambov, 392013, Russia

Location

Republican Clinical Oncology Center

Ufa, 450054, Russia

Location

Volgograd Regional Clinical Oncology Center

Volgograd, 400138, Russia

Location

National Cancer Research Center

Belgrade, 11000, Serbia

Location

Oncology Institute of Vojvodina (IOV), Clinic of Surgical Oncology, Department of Gynecology

Kamenitz, 21204, Serbia

Location

Clinical Center Nis, Clinic of Oncology

Niš, 18000, Serbia

Location

National University Hospital, Department of Hematology-Oncology

Singapore, 119074, Singapore

Location

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

Location

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 3722, South Korea

Location

Samsung Medical Center

Seoul, 6351, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 6591, South Korea

Location

Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council

Cherkasy, 18099, Ukraine

Location

Chernivtsi Regional Clinical Oncology Center

Chernivtsi, 58013, Ukraine

Location

"City Clinical Hospital #4" under Dnipro City Council

Dnipro, 49102, Ukraine

Location

Prykarpattia Clinical Oncology Center

Ivano-Frankivsk, 76018, Ukraine

Location

State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences

Kharkiv, 61024, Ukraine

Location

Communal Non-profit enterprise "Regional Center of Oncology"

Kharkiv, 61070, Ukraine

Location

Medical Center "Verum"

Kyiv, 3039, Ukraine

Location

Odesa Regional Clinical Hospital

Odesa, 65025, Ukraine

Location

Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center

Ternopil, 46023, Ukraine

Location

Podilla Regional Oncology Center

Vinnytsia, 21029, Ukraine

Location

Medical Center ONCOLIFE LLC

Zaporizhzhia, 69059, Ukraine

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

trastuzumab duocarmazine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Clinical Development
• Organization: Byondis B.V.

clinicaltrials@byondis.com

0031246795101

Study Officials

• Clinical Development

  Byondis B.V., The Netherlands

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 19, 2019
• Study Start: May 28, 2020
• Primary Completion: January 26, 2023
• Study Completion: April 25, 2023
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); PL (2); RU (12); SG (2); KR (5); UA (11); SE (3)