A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Public ClinicalTrials.gov record NCT06340568. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06340568
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 480 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 9, 2025
- Primary completion
- Feb 29, 2028
- Completion
- Oct 31, 2029
- Last update posted
- Aug 31, 2026
2025 – 2029
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | Recruiting |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | Recruiting |
| Carle Cancer Institute | Urbana | Illinois | 61801 | Recruiting |
| WK Cancer Center | Shreveport | Louisiana | 71103 | Recruiting |
| The Center of Hope Reno | Reno | Nevada | 89511 | Recruiting |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | Recruiting |
| NYU Langone Health | New York | New York | 10016 | Recruiting |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | Recruiting |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | Recruiting |
| Ohio State University | Hilliard | Ohio | 43026 | Recruiting |
| Peggy & Charles Stephenson Oklahoma Cancer Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Sanford Cancer Center | Sioux Falls | South Dakota | 57104 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 167 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06340568, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 31, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06340568 live on ClinicalTrials.gov.