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A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
NCT06340568 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06340568
The ClinicalTrials.gov registry entry for NCT06340568 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06340568 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, District of Columbia, Nevada. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06340568?
The interventions under investigation include: Docetaxel (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), BNT323/DB-1303 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06340568?
This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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