A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the endometrial cancer population with prior immune checkpoint inhibitor (ICI) treatment.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).
• Have histologically confirmed endometrial cancer that:
‣ Is recurrent,
⁃ Has a HER2 IHC score of 1+, 2+, or 3+ as determined by central laboratory testing for HER2 protein expression, and
⁃ Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.
• Have measurable disease defined by RECIST 1.1.
• Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
• Have had at least one prior line of platinum-based therapy (in any setting). Up to three lines of prior therapy are allowed. Prior hormonal therapy and radiation are allowed and do not count as prior lines of therapy. Platinum-based chemotherapy and ICI may have been given together or in separate lines of therapy.
• Have a life expectancy of ≥12 weeks at screening.
Locations
Other Locations
Australia
Gosford Hospital
RECRUITING
Gosford
Sunshine Hospital
RECRUITING
Saint Albans
Mater Hospital Brisbane
RECRUITING
South Brisbane
Wollongong Hospital
NOT_YET_RECRUITING
Wollongong
Canada
Health Sciences Centre
RECRUITING
St. John's
China
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Gansu Provincial Maternity and Child-care Hospital
RECRUITING
Lanzhou
Jiangxi Maternal and Child Health Hospital
RECRUITING
Nanchang
The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital
RECRUITING
Nanning
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital
RECRUITING
Wuhan
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Xiangyang Central Hospital
RECRUITING
Xiangyang
The Second Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Republic of Korea
Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
MacKay Memorial Hospital_ Taipei Branch
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Castle Hill Hospital
RECRUITING
Cottingham
Royal Cornwall Hospital
RECRUITING
Truro
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date:2025-06-10
Estimated Completion Date:2029-11
Participants
Target number of participants:504
Treatments
Experimental: BNT323/DB-1303
Active_comparator: Doxorubicin or paclitaxel
Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice