Clinical Study of BNT323/DB-1303 or Chemotherapy for Recurring Uterine Cancer
This study is testing an investigational therapy called BNT323/DB-1303, or standard chemotherapy (doxorubicin, paclitaxel, or docetaxel), for women with recurrent (returned) endometrial cancer (a type of uterine cancer). You could be eligible if you are an adult woman with endometrial cancer that has come back, and your tumor has specific levels of a biomarker (a measurable indicator) called HER2. The study is divided into two groups based on your HER2 levels. For some, success means the treatment slows down cancer growth (progression-free survival), while for others, it means the tumor shrinks or disappears (objective response rate). The study aims to enroll 480 participants, but its current recruitment status is unclear.
- Study design
- This is an open-label, randomized, multi-site Phase III study. Participants in Cohort 1 will be randomly assigned to receive either BNT323/DB-1303 or chemotherapy, while Cohort 2 participants will receive BNT323/DB-1303 alone. The study plans to enroll 480 participants.
- What's involved
- Participants will receive BNT323/DB-1303 or chemotherapy through intravenous (IV) infusion or bolus until their disease progresses, they experience unacceptable side effects, or they withdraw consent.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to approximately 53 months to assess how well the treatment works.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06340568
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Recruiting
PHASE3Ages 18+InterventionalTreatmentBioNTech SE
~480 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:BNT323/DB-1303DoxorubicinPaclitaxelDocetaxel
At a glance
Recruiting sites
171 of 171 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
Measured over Up to approximately 53 months
+1 more outcome measured
Conditions
Where it's being run
171 sites across 50 statesSouth Korea13
United Kingdom13
Italy11
Australia10
Brazil9
Spain9
France8
Belgium6
Study leadership
- BioNTech Responsible Person · STUDY_DIRECTOR · BioNTech SE
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).
Have histologically confirmed 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 expression, and
Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.
Have measurable disease defined by RECIST v1.1.
Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
Have recurrent endometrial cancer and meet any of the following:
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.
Have received prior ICI treatment (i.e., anti-programmed death 1/anti-programmed death-ligand 1)
Have a life expectancy of ≥12 weeks at screening.
Exclusion
Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).
Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment.
Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.
Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment.
Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Participants with prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg/day of prednisone or equivalent, and topical corticosteroids. Participants receiving corticosteroids may continue if the dose is stable upon giving main informed consent.
Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to the first dose of study treatment, severe asthma, chronic obstructive pulmonary disorder with moderate acute exacerbations, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete).
Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment.
Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline.
Are pregnant or breastfeeding or are planning pregnancy during the study or within 7 months after the last dose of study treatment.
Have a history of allergies, hypersensitivities, or intolerance to study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies. Participants who have successfully undergone a desensitization process and are able to tolerate the drug are eligible.
Had prior treatment with topoisomerase I inhibitors, including ADCs.
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.
What this trial measures
- Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancerUp to approximately 53 months
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.
- Cohort 2: ORR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancerUp to approximately 53 months
Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation.