OncoMatch/Clinical Trials/NCT06340568
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Is NCT06340568 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BNT323/DB-1303 and Doxorubicin for endometrial cancer.
Treatment: BNT323/DB-1303 · Doxorubicin · Paclitaxel · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: HER2 (ERBB2) IHC score of 1+, 2+, or 3+ (IHC 1+, 2+, or 3+)
Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — adjuvant or recurrent/metastatic
developed recurrence <12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or developed recurrence after platinum-based chemotherapy in the recurrent/metastatic setting
Must have received: anti-PD-1 therapy or anti-PD-L1 therapy
Have received prior ICI treatment (i.e., anti-programmed death 1/anti-programmed death-ligand 1)
Cannot have received: topoisomerase I inhibitor
Had prior treatment with topoisomerase I inhibitors, including ADCs
Lab requirements
Cardiac function
left ventricular ejection fraction <55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E/e' ratio >15.
Have left ventricular ejection fraction <55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E/e' ratio >15.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MedStar Washington Hospital Center · Washington D.C., District of Columbia
- Broward Health Medical Center · Fort Lauderdale, Florida
- The Center of Hope Reno · Reno, Nevada
- Miami Valley Hospital South · Centerville, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify