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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06340568




Registration number
NCT06340568
Ethics application status
Date submitted
25/03/2024
Date registered
1/04/2024
Date last updated
20/08/2025

Titles & IDs
Public title
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Scientific 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
Secondary ID [1] 0 0
GOG-3105
Secondary ID [2] 0 0
BNT323-01
Universal Trial Number (UTN)
Trial acronym
Fern-EC-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BNT323/DB-1303
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Paclitaxel

Experimental: BNT323/DB-1303 -

Active comparator: Doxorubicin or paclitaxel - Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice


Treatment: Drugs: BNT323/DB-1303
intravenous (IV) infusion

Treatment: Drugs: Doxorubicin
IV bolus or infusion

Treatment: Drugs: Paclitaxel
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PFS assessed by BICR in the endometrial cancer population in participants with prior ICI treatment
Timepoint [1] 0 0
Up to approximately 32 months
Secondary outcome [1] 0 0
PFS assessed by BICR in the endometrial cancer population in all participants with HER2-expressing recurrent endometrial cancer
Timepoint [1] 0 0
Up to approximately 32 months
Secondary outcome [2] 0 0
Overall survival (OS) in the endometrial cancer population in participants with prior ICI treatment and in all participants
Timepoint [2] 0 0
Up to approximately 55 months
Secondary outcome [3] 0 0
PFS assessed by the investigator in the endometrial cancer population in participants with prior ICI treatment and in all participants
Timepoint [3] 0 0
Up to approximately 32 months
Secondary outcome [4] 0 0
Objective response rate (ORR) assessed by BICR in the endometrial cancer population in participants with prior ICI treatment and in all participants
Timepoint [4] 0 0
Up to approximately 55 months
Secondary outcome [5] 0 0
ORR assessed by the investigator in the endometrial cancer population in participants with prior ICI treatment and in all participants
Timepoint [5] 0 0
Up to approximately 55 months
Secondary outcome [6] 0 0
Duration of response (DoR) assessed by BICR in the endometrial cancer population in participants with prior ICI treatment and in all participants
Timepoint [6] 0 0
Up to approximately 55 months
Secondary outcome [7] 0 0
DoR assessed by the investigator in the endometrial cancer population in participants with prior ICI treatment and in all participants
Timepoint [7] 0 0
Up to approximately 55 months
Secondary outcome [8] 0 0
Percentage of participants with occurrence of treatment-emergent adverse events (TEAEs)
Timepoint [8] 0 0
Up to 35 days after the last dose of study treatment
Secondary outcome [9] 0 0
Percentage of participants with occurrence of TEAEs leading to drug interruption, dose reduction, or discontinuation of study treatment.
Timepoint [9] 0 0
Up to 35 days after the last dose of study treatment

Eligibility
Key inclusion criteria
Key

* 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+, or 3+ as determined by central laboratory testing for HER2 protein 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 1.1.
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
* Have had at least one prior line of platinum-based therapy (in any setting). Up to three lines of prior therapy are allowed. Prior hormonal therapy and radiation are allowed and do not count as prior lines of therapy. Platinum-based chemotherapy and ICI may have been given together or in separate lines of therapy.
* Have a life expectancy of =12 weeks at screening.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Ineligible for all options in the investigator's choice of chemotherapy arm. Participants with contraindications to paclitaxel and doxorubicin treatment, per local prescribing information and institutional guidelines, cannot be enrolled to the study.
* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to randomization.
* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events (AEs).
* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization.
* 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 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 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 study randomization, severe asthma, severe chronic obstructive pulmonary disorder, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), and 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 randomization.
* Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia) 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 the study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies.
* Had prior treatment with topoisomerase I inhibitors, including ADCs with exatecans.
* Have left ventricular ejection fraction (LVEF) <55% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before randomization. This includes participants with tissue doppler E/e' ratio >15.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2029
Actual
Sample size
Target
504
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sunshine Hospital - Saint Albans
Recruitment postcode(s) [1] 0 0
3021 - Saint Albans
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Guangdong
Country [2] 0 0
China
State/province [2] 0 0
Hubei
Country [3] 0 0
China
State/province [3] 0 0
Jiangxi
Country [4] 0 0
China
State/province [4] 0 0
Shanghai
Country [5] 0 0
Taiwan
State/province [5] 0 0
Taichung
Country [6] 0 0
Taiwan
State/province [6] 0 0
Tainan City
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioNTech SE
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
DualityBio Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
BioNTech Responsible Person
Address 0 0
BioNTech SE
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BioNTech clinical trials patient information
Address 0 0
Country 0 0
Phone 0 0
+49 6131 9084
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06340568