Condition: Endometrial Cancer · Sponsor: BioNTech SE
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.
This description comes directly from the study's public registry record.
BioNTech clinical trials patient information · +49 6131 9084 · patients@biontech.de
Always discuss trial participation with your own doctor first.
| Yale University School of Medicine | New Haven, Connecticut, United States | Recruiting |
| MedStar Washington Hospital Center | Washington D.C., District of Columbia, United States | Recruiting |
| Broward Health Medical Center | Fort Lauderdale, Florida, United States | Recruiting |
| OSF Saint Francis Medical Center | Peoria, Illinois, United States | Recruiting |
| The Center of Hope Reno | Reno, Nevada, United States | Recruiting |
| NYU Langone Hospital - Long Island | Mineola, New York, United States | Recruiting |
| NYU Langone Health | New York, New York, United States | Recruiting |
| Miami Valley Hospital South | Centerville, Ohio, United States | Recruiting |
| Ohio State University | Hilliard, Ohio, United States | Recruiting |
| Sanford Cancer Center | Sioux Falls, South Dakota, United States | Recruiting |
| Hospital Británico de Buenos Aires | Buenos Aires, Argentina | Recruiting |
| Investigaciones CORI S.R.L. | La Rioja, Argentina | Recruiting |
+ 159 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06340568