Endometrial CancerPhase 3Fern-EC-01NCT06340568
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
A Phase 3 study testing BNT323/DB-1303, Doxorubicin and Paclitaxel in people with Endometrial Cancer, run by BioNTech SE at 206 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- BNT323/DB-1303, Doxorubicin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 206 sitesin 27 countries
- Study dates
- 10 Jun 2025to Nov 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
206 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
206 sites in 27 countries
China28 sites, 28 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150091
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
- Recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
- Recruiting
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, 730050
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276001
- Recruiting
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006
- Recruiting
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530200
- Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515063
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
Union Hospital
Wuhan, 430048
- Recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
- Recruiting
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441138
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
- Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
United States22 sites, 22 recruiting
- Recruiting
University of Colorado Cancer Center
Aurora, Colorado, 80045
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
- Recruiting
Ohio State University
Hilliard, Ohio, 43026
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
- Recruiting
USC/Norris Cancer Center
Los Angeles, California, 90033
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
- Recruiting
Minnesota Oncology
Minneapolis, Minnesota, 55404
- Recruiting
Intermountain Healthcare
Murray, Utah, 84107-5701
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06520
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
- Recruiting
Peggy & Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, 73104
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
- Recruiting
The Center of Hope Reno
Reno, Nevada, 89511
- Recruiting
WK Cancer Center
Shreveport, Louisiana, 71103
- Recruiting
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
- Recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
- Recruiting
Texas Oncology, P.A.
Tyler, Texas, 75702
- Recruiting
Carle Cancer Institute
Urbana, Illinois, 61801
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
- Recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
South Korea13 sites, 13 recruiting
- Recruiting
Samsung Changwon Hospital
Changwon, 51353
- Recruiting
Keimyung Univty Dongsan Hospital
Daegu, 42601
- Recruiting
National Cancer Center
Goyang, 10408
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
- Recruiting
CHA Bundang Medical Center
Seongnam-si, 13496
- Recruiting
Korea University Anam Hospital
Seoul, 02841
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
- Recruiting
Ewha Womans University Seoul Hospital
Seoul, 07804
United Kingdom13 sites, 13 recruiting
- Recruiting
Royal Sussex County Hospital
Brighton, BN2 1ES
- Recruiting
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
- Recruiting
Castle Hill Hospital
Cottingham, HU165JQ
- Recruiting
Warwick Hospital
Coventry, CV2 2DX
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
- Recruiting
Royal Devon & Exeter HPT
Exeter, EX2 5DW
- Recruiting
University College London Hospitals
London, NW1 2PG
- Recruiting
Guy's Hospital
London, SE1 9RT
- Recruiting
Mount Vermont Cancer Center
Middlesex, HA6 2RN
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
- Recruiting
Singleton Hospital
Swansea, SA2 8QA
- Recruiting
Royal Cornwall Hospital
Truro, TR1 3LJ
Italy11 sites, 11 recruiting
- Recruiting
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, 70124
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138
- Recruiting
Azienda Ospedaliera Cannizzaro - Oncologia
Catania, 95126
- Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
Meldola, 47014
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Istituto Nazionale dei Tumori
Milan, 20133
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
- Recruiting
Humanitas San Pio X
Milan, 20159
- Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, 80131
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
- Recruiting
Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
Torino, 10128
Australia10 sites, 10 recruiting
- Recruiting
Adelaide Oncology & Haematology
Adelaide, 5000
- Recruiting
Cancer Research SA
Adelaide, 5000
- Recruiting
Monash Health Clinical Trial Center
Clayton, 3168
- Recruiting
Gosford Hospital
Gosford, 2250
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
- Recruiting
Frankston Hospital
Melbourne, VIC 3199
- Recruiting
Shoalhaven Cancer Care Centre
Nowra, 2541
- Recruiting
Sunshine Hospital
Saint Albans, 3021
- Recruiting
Mater Hospital Brisbane
South Brisbane, 4001
- Recruiting
Wollongong Hospital
Wollongong, 2500
Spain10 sites, 10 recruiting
- Recruiting
Hospital Universitari Vall, d'Hebron
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Recruiting
Hospital Universitar Donostia
Donostia / San Sebastian, 20014
- Recruiting
Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta
Girona, 17007
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universit Son Espases
Palma de Mallorca, 07120
- Recruiting
Instituto Valenciano de Oncología - Valencia
Valencia, 46009
Argentina9 sites, 9 recruiting
- Recruiting
Centro de Oncologia Dr. Doreski - Fundación Respirar
Buenos Aires, 01426
- Recruiting
Centro de Investigaciones Medicas Mar del Plata
Buenos Aires, B7600FYK
- Recruiting
Hospital Británico de Buenos Aires
Buenos Aires, C1280AEB
- Recruiting
CEMAIC - Centro Medico Privado
Córdoba, X5008AAC
- Recruiting
Investigaciones CORI S.R.L.
La Rioja, F5300COE
- Recruiting
Fundación Oncológica Mendoza
Mendoza, M5500
- Recruiting
Hospital Provincial del Centenario
Rosario, S2002KDS
- Recruiting
Centro Oncológico de Excelencia
San Juan, 5400
- Recruiting
Clinica Mayo de Urgencias
San Miguel de Tucumán, 4000
Brazil9 sites, 9 recruiting
- Recruiting
Fundação Sao Francisco Xavier
Ipatinga, 35162-189
- Recruiting
Hospital de Clínicas de Passo Fundo
Passo Fundo, 99010-260
- Recruiting
Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
Porto Alegre, 90035-000
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170
- Recruiting
HPT São Lucas da PUCRS - UBEA
Porto Alegre, 90610-000
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Petro
São José do Rio Preto, 15090-000
- Recruiting
Hospital Sirio Libanês
São Paulo, 01308-050
- Recruiting
Inst D'Or de Pesquisa E Ensino
São Paulo, 01401-002
Belgium8 sites, 8 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
- Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, 2650
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
AZ Groeninge VZW
Kortrijk, 8500
- Recruiting
UZ Leuven
Leuven, 3000
- Recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
- Recruiting
CHU UCL Namur-Sainte-Elisabeth
Namur, B5000
France8 sites, 8 recruiting
- Recruiting
ICO - Site Paul Papin
Angers, 49055
- Recruiting
CHU Besançon Service Oncologie
Besançon, 25000
- Recruiting
Centre François Baclesse
Caen, 14000
- Recruiting
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000
- Recruiting
Hôpital Nord Bâtiment Mistral
Marseille, 13015
- Recruiting
Hôpital Saint Louis
Paris, 75010
- Recruiting
ICO - Site René Gauducheau
Saint-Herblain, 44800
- Recruiting
Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, 67000
Israel8 sites, 8 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 382302
- Recruiting
Lady Davis Carmel Medical Center
Haifa, 3436212
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
- Recruiting
Shaare Zedek
Jerusalem, 9103102
- Recruiting
Hadassah Ein Kerem Medical Center
Jerusalem, 9112001
- Recruiting
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492
- Recruiting
Sheba Medical Center
Ramat Gan, 5265601
- Recruiting
Sourasky Medical Centre
Tel Aviv, 642390
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Baskent University Adana Application and Research Center
Adana, 01120
- Recruiting
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, 06200
- Recruiting
Hacettepe University
Ankara, 06230
- Recruiting
Baskent University Ankara Hospital
Ankara, 06490
- Recruiting
İzmir City Hospital
Bayraklı, 35540
- Recruiting
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, 34093
- Recruiting
Istanbul University Istanbul Medical Faculty
Istanbul, 34093
Czechia6 sites, 6 recruiting
- Recruiting
Gynekologicko-porodnická klinika, Fakultni nemocnice Brno
Brno, 60200
- Recruiting
University Hospital Olomouc - Onkologická klinika- Fakultni
Olomouc, 77900
- Recruiting
Fakultní nemocnice Ostrava
Ostrava, 01790
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
- Recruiting
Fakultní nemocnice Motol a Homolka
Prague, 15000
- Recruiting
Fakultní nemocnice Bulovka
Prague, 18081
Taiwan6 sites, 6 recruiting
- Recruiting
China Medical University Hospital
Taichung, 40447
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Recruiting
Kuang Tien General Hospital
Taichung, 433004
- Recruiting
National Cheng Kung University Hospital
Tainan, 70457
- Recruiting
MacKay Memorial Hospital_ Taipei Branch
Taipei, 10449
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Germany5 sites, 5 recruiting
- Recruiting
Charité - Campus Virchow-Klinikum
Berlin, 13353
- Recruiting
Kliniken Essen-Mitte
Essen, 45136
- Recruiting
Klinkum Kassel
Kassel, 34125
- Recruiting
LMU-Campus Innenstadt
München, 81377
- Recruiting
Universitaets-Frauenklinik, Tübingen
Tübingen, 72076
Greece5 sites, 5 recruiting
- Recruiting
Alexandra General Hospital of Athens
Athens, 11528
- Recruiting
Aretaieio Hospital
Athens, 11528
- Recruiting
University General Hospital Attikon
Chaïdári, 124 62
- Recruiting
General Hospital of Kalamata
Kalamata, 24100
- Recruiting
IASO General Clinic
Marousi, 151 23
Hungary5 sites, 5 recruiting
- Recruiting
Semmelweis Egyetem
Budapest, 1088
- Recruiting
Országos Onkológiai Intézet
Budapest, 1122
- Recruiting
Debreceni Egyetem
Debrecen, 4032
- Recruiting
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, 6000
- Recruiting
Zala Varmegyei Szent Rafael Korhaz
Zalaegerszeg, 8900
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg Universit Hospital
Aalborg, 9000
- Recruiting
Rigshospitalet
Copenhagen, 2100
- Recruiting
Herlev og Gentofte Hospital
Herlev, 2730
- Recruiting
Odense University Hospital
Odense, 5000
Canada3 sites, 3 recruiting
- Recruiting
Jewish General Hospital
Montreal, H3T 1E2
- Recruiting
Health Sciences Centre
St. John's, A1V 3V6
- Recruiting
Princess Margaret Cancer C
Toronto, M5G 2M9
Finland3 sites, 3 recruiting
- Recruiting
Kuopio University HPT
Kuopio, 70210
- Recruiting
OYS Naisten poliklinikka
Oulu, 90029
- Recruiting
Turun yliopistollinen keskussairaala
Turku, 20521
Poland3 sites, 3 recruiting
- Recruiting
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
Bialystok, 15-027
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
- Recruiting
Siedleckie Centrum Onkologii
Siedlce, 08-110
Sweden3 sites, 3 recruiting
- Recruiting
Skånes Universitetssjukhus Lund
Lund, 222 42
- Recruiting
Karolinska University Hospital
Stockholm, 17176
- Recruiting
Akademiska Sjukhuset
Uppsala, 75185
Netherlands2 sites, 2 recruiting
- Recruiting
Radboud UMC
Nijmegen, 6525 GA
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 AA
Norway2 sites, 2 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0379
- Recruiting
Stavanger University Hospital
Stavanger, 4011
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
- Recruiting
OncoCare Cancer Centre
Singapore, 258499
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, A-1090
About this study
Official 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
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Endometrial Cancer
- Being tested
- BNT323/DB-1303, Doxorubicin, Paclitaxel, Docetaxel
- Keywords
- Human epidermal growth factor receptor 2 (HER2), HER2-expressing tumors, Recurrent endometrial cancer, IHC scores 1+, 2+, and 3+, Immune checkpoint inhibitor, Platinum-based therapy, HER2 protein expression, HER2-expressing endometrial cancer, ErbB-2 receptor, Antibody drug conjugate (ADC)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT323/DB-1303Drug
Also called trastuzumab pamirtecan
intravenous (IV) infusion
DoxorubicinDrug
IV bolus or infusion
PaclitaxelDrug
IV infusion
DocetaxelDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (HER2 IHC score 1+ or 2+): BNT323/DB-1303 | Experimental | Not described Receives: Drug: BNT323/DB-1303 |
| Cohort 1 - Doxorubicin or paclitaxel (or docetaxel) | Active comparator | Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice. Participants with contraindications to paclitaxel may receive docetaxel as an alternative (if available at the site). Receives: Drug: Doxorubicin; Drug: Paclitaxel; Drug: Docetaxel |
| Cohort 2 (HER2 IHC score 3+) - BNT323/DB-1303 | Experimental | Not described Receives: Drug: BNT323/DB-1303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
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.
Measured: Up to approximately 53 months
Cohort 2: ORR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation.
Measured: Up to approximately 53 months
Secondary outcomes (16)
Cohort 1: Overall survival (OS) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
By treatment arm. Defined as the time from randomization to death from any cause.
Measured: Up to approximately 53 months
Cohort 1: PFS assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
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.
Measured: Up to approximately 53 months
Cohort 1: ORR assessed by BICR in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
By treatment arm. Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation.
Measured: Up to approximately 53 months
Cohort 1: ORR assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
By treatment arm. Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation.
Measured: Up to approximately 53 months
Cohort 1: Duration of response (DoR) assessed by BICR in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
By treatment arm. Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: Up to approximately 53 months
Cohort 1: DoR assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
By treatment arm. Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: Up to approximately 53 months
Cohort 1: Percentage of participants with HER2 IHC 1+/2+ recurrent endometrial cancer with occurrence of treatment-emergent adverse events (TEAEs)
By treatment arm. TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship.
Measured: Up to 35 days after the last dose of study treatment
Cohort 1: Percentage of participants with HER2 IHC 1+/2+ recurrent endometrial cancer with occurrence of TEAEs leading to drug interruption, dose reduction, or discontinuation of study treatment.
By treatment arm.
Measured: Up to 35 days after the last dose of study treatment
Cohort 2: ORR assessed by the investigator participants with HER2 IHC 3+ recurrent endometrial cancer
Defined as the proportion of participants in whom a CR or PR (per RECIST v1.1) is observed as best overall response with confirmation.
Measured: Up to approximately 53 months
Cohort 2: DoR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: Up to approximately 53 months
Cohort 2: DoR assessed by the investigator in participants with HER2 IHC 3+ recurrent endometrial cancer
Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: Up to approximately 53 months
Cohort 2: PFS assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
Defined as the time from the first dose of study treatment to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: Up to approximately 53 months
Cohort 2: PFS assessed by the investigator in participants with HER2 IHC 3+ recurrent endometrial cancer
Defined as the time from the first dose of study treatment to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: Up to approximately 53 months
Cohort 2: OS in participants with HER2 IHC 3+ recurrent endometrial cancer
Defined as the time from the first dose of trial treatment to death from any cause.
Measured: Up to approximately 53 months
Cohort 2: Percentage of participants with HER2 IHC 3+ recurrent endometrial cancer with occurrence of TEAEs
BNT323 monotherapy. TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship.
Measured: Up to 35 days after the last dose of study treatment
Cohort 2: Percentage of participants with HER2 IHC 3+ recurrent endometrial cancer with occurrence of TEAEs leading to drug interruption, dose reduction, or discontinuation of study treatment.
Measured: Up to 35 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start10 Jun 2025
- Primary completionMar 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DualityBio Inc., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340568
- Sponsor's protocol ID
- BNT323-01
- Other IDs
- GOG-3105, 2023-507525-42-00, ENGOT- EN25/NSGO-CTU, 2023
- Acronym
- Fern-EC-01
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.
PubMed 40966692