A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
BNT323/DB-1303: intravenous (IV) infusion
Doxorubicin: IV bolus or infusion
Paclitaxel: IV infusion
Docetaxel: IV infusion
Study summary
The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.
In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \[or docetaxel, if participants cannot take paclitaxel\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs).
In Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment.
The safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.
Eligibility
Primary outcome measure(s)
- Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer — Up to approximately 53 months
By treatment arm. Defined as the time from randomization to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. - Cohort 2: ORR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer — Up to approximately 53 months
Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation.
Trial sites (206)
| Facility | City | Region | Status |
|---|---|---|---|
| USC/Norris Cancer Center | Los Angeles | California | Recruiting |
| University of Colorado Cancer Center | Aurora | Colorado | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| Broward Health Medical Center | Fort Lauderdale | Florida | Recruiting |
| OSF Saint Francis Medical Center | Peoria | Illinois | Recruiting |
| Carle Cancer Institute | Urbana | Illinois | Recruiting |
| Baptist Health Lexington | Lexington | Kentucky | Recruiting |
| WK Cancer Center | Shreveport | Louisiana | Recruiting |
| Minnesota Oncology | Minneapolis | Minnesota | Recruiting |
| The Center of Hope Reno | Reno | Nevada | Recruiting |
| NYU Langone Hospital - Long Island | Mineola | New York | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| SUNY Upstate Medical University | Syracuse | New York | Recruiting |
| Miami Valley Hospital South | Centerville | Ohio | Recruiting |
| Ohio State University | Hilliard | Ohio | Recruiting |
| Peggy & Charles Stephenson Oklahoma Cancer Center | Oklahoma City | Oklahoma | Recruiting |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | Recruiting |
| Sanford Cancer Center | Sioux Falls | South Dakota | Recruiting |
| Texas Oncology, P.A. | Tyler | Texas | Recruiting |
| Intermountain Healthcare | Murray | Utah | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | Recruiting |
| Centro de Oncologia Dr. Doreski - Fundación Respirar | Buenos Aires | Argentina | Recruiting |
| Centro de Investigaciones Medicas Mar del Plata | Buenos Aires | Argentina | Recruiting |
| Hospital Británico de Buenos Aires | Buenos Aires | Argentina | Recruiting |
| CEMAIC - Centro Medico Privado | Córdoba | Argentina | Recruiting |
| Investigaciones CORI S.R.L. | La Rioja | Argentina | Recruiting |
| Fundación Oncológica Mendoza | Mendoza | Argentina | Recruiting |
| Hospital Provincial del Centenario | Rosario | Argentina | Recruiting |
| Centro Oncológico de Excelencia | San Juan | Argentina | Recruiting |
| Clinica Mayo de Urgencias | San Miguel de Tucumán | Argentina | Recruiting |
| Adelaide Oncology & Haematology | Adelaide | Australia | Recruiting |
| Cancer Research SA | Adelaide | Australia | Recruiting |
| Monash Health Clinical Trial Center | Clayton | Australia | Recruiting |
| Gosford Hospital | Gosford | Australia | Recruiting |
| Peter MacCallum Cancer Centre | Melbourne | Australia | Recruiting |
| Frankston Hospital | Melbourne | Australia | Recruiting |
| Shoalhaven Cancer Care Centre | Nowra | Australia | Recruiting |
| Sunshine Hospital | Saint Albans | Australia | Recruiting |
| Mater Hospital Brisbane | South Brisbane | Australia | Recruiting |
+ 166 more sites — see the full list on the official registry below.
More BioNTech SE trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06340568 on ClinicalTrials.gov ↗ ← All trials in the UK