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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06340568.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Approved
Name Not Available
This is an open-label, randomized, multi-site, Phase III, interventional clinical study
designed to determine the efficacy and safety of BNT323 compared with investigator's
choice of single agent chemotherapy in previously treated participants with recurrent
endometrial cancer (including HER2 1+ or 2+ score as determined using a centralized
immunohistochemistry [IHC] analysis method), whose disease has progressed on at least one
line of platinum-based therapy and ICI (Cohort 1). In addition, participants with
recurrent endometrial cancer with HER2 IHC 3+ score will be enrolled in a BNT323
monotherapy arm (Cohort 2) to further investigate the efficacy and safety of BNT323.
In Cohort 1, participants will be randomized 2:1 to receive either BNT323/DB-1303 or
investigator's choice of single agent chemotherapy, preferably doxorubicin or paclitaxel
(or docetaxel if contraindicated to paclitaxel and available at the site) until Response
Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) defined progressive disease
(PD) unless there is unacceptable toxicity, withdrawal of consent, or another criterion
for discontinuation is met.
In Cohort 2, participants will receive BNT323 monotherapy until RECIST v1.1 defined PD
unless there is unacceptable toxicity, withdrawal of consent, or another criterion for
discontinuation is met.
The study consists of a screening period, a treatment period, a safety follow-up period,
an efficacy follow-up period, and a long-term survival follow-up. The expected treatment
duration per participant is ~6 months, followed by an anticipated long-term survival
follow-up period of up to 53 months.
Lead OrganizationBiontech SE