At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BNT323/DB-1303 (drug), Doxorubicin (drug), Paclitaxel (drug), Docetaxel (drug)
- How long the study runs
- Study runs about 53 months (dates as stated)
- About the drug or intervention
- BNT323/DB-1303 — drug: intravenous (IV) infusion · Doxorubicin — drug: IV bolus or infusion · Paclitaxel — drug: IV infusion · Docetaxel — drug: IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 480
- Started
- 2025-06-10
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for endometrial cancer
- • Phase3 - 480 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with endometrial cancer
- • Female only
Where?
- • Brighton - Royal Sussex County Hospital
- • Bristol - Bristol Haematology and Oncology Centre
- • Cambridge - Addenbrooke's Hospital
- • Cottingham - Castle Hill Hospital
- • +9 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of...
- ✓Have confirmed by a biopsy endometrial cancer that:
- ✓Is recurrent,
- ✓Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2...
- ✓Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma...
Who cannot take part
- ✗Are ineligible for all options in the investigator's choice of drug treatment arm, per local prescribing information...
- ✗Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of...
- ✗Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially...
- ✗Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal...
- ✗Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the...
See the full criteria
Where Is This Study? (13 UK sites)
Royal Sussex County Hospital
Brighton BN2 1ES, United Kingdom
Bristol Haematology and Oncology Centre
Bristol BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Castle Hill Hospital
Cottingham HU165JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Warwick Hospital
Coventry CV2 2DX, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Royal Devon & Exeter HPT
Exeter EX2 5DW, United Kingdom
University College London Hospitals
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Guy's Hospital
London SE1 9RT, United Kingdom
Mount Vermont Cancer Center
Middlesex HA6 2RN, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham NG5 1PB, United Kingdom
Singleton Hospital
Swansea SA2 8QA, United Kingdom
Royal Cornwall Hospital
Truro TR1 3LJ, United Kingdom
How to Get in Touch
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