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NCT06340568 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
A Phase 3 study of Endometrial Cancer, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 480
- Enrollment target
- 20
- Study locations
NCT06340568: Recruiting Phase 3 study of Endometrial Cancer, sponsored by BioNTech SE.
NCT06340568 is a Phase 3 study of Endometrial Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 480 participants, roughly in line with the 521-participant average among 181 other Endometrial Cancer trials with a reported enrollment target. The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06340568, a Phase 3 study of Endometrial Cancer, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 480 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG BNT323/DB-1303
Study Locations (20)
Other
- Hospital Británico de Buenos Aires - Buenos Aires
- Investigaciones CORI S.R.L. - La Rioja
- Hospital Provincial del Centenario - Rosario
- Centro Oncológico de Excelencia - San Juan
- Adelaide Oncology & Haematology - Adelaide
- Cancer Research SA - Adelaide
- Gosford Hospital - Gosford
- Frankston Hospital - Melbourne
- Sunshine Hospital - Saint Albans
- Mater Hospital Brisbane - South Brisbane
- Wollongong Hospital - Wollongong
- UZ Leuven - Leuven
- CHU UCL Namur-Sainte-Elisabeth - Namur
- Hospital de Clínicas de Passo Fundo - Passo Fundo
- Irmandade da Santa Casa de Misericórdia de Porto Alegre - Porto Alegre
- Jewish General Hospital - Montreal
- Health Sciences Centre - St. John's
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Nevada
- The Center of Hope Reno - Reno
Ohio
- Miami Valley Hospital South - Centerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2025-06-10 |
| Est. Completion | 2029-11 |
| Phase | Phase 3 |
What NCT06340568 shows while recruiting
NCT06340568 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 521-participant average among 181 other Endometrial Cancer trials with a reported enrollment target.
The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.
NCT06340568 names 20 study sites across 4 states, led by Other, District of Columbia, Nevada.
Frequently Asked Questions
What is clinical trial NCT06340568 about?
NCT06340568 is a clinical study titled "A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer". 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 (doxoru...
What is the current status of trial NCT06340568?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2025-06-10. Estimated completion is 2029-11.
What conditions does trial NCT06340568 study?
This clinical trial studies the following conditions: Endometrial Cancer.
What interventions are being tested in trial NCT06340568?
The interventions under investigation include: Docetaxel (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), BNT323/DB-1303 (DRUG).
Who is sponsoring clinical trial NCT06340568?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06340568 being conducted?
This trial has 20 study locations across District of Columbia, Nevada, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometrial Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06340568's enrollment target sits among peer trials
480 34th of 181 higher than 148 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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