Actively Recruiting
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
Led by BioNTech SE · Updated on 2026-04-17
380
Participants Needed
39
Research Sites
209 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
D
DualityBio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 in combination with BNT327 in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).
CONDITIONS
Official Title
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have pathologically confirmed breast cancer that is locally advanced, unresectable, or metastatic
- Confirmed HER2 status by local or central laboratory from recent tumor sample
- Documented HER2 expression consistent with subgroup definitions (HER2-low, HER2-ultralow, HER2-null, HER2-positive, or triple-negative breast cancer)
- Measurable disease as defined by RECIST v1.1
- Left ventricular ejection fraction of 55% or higher by echocardiography or multi-gated acquisition within 28 days before enrollment
You will not qualify if you...
- History of small bowel obstruction requiring hospitalization within 3 months before first study dose
- Uncontrolled illness limiting study compliance or increasing risk of adverse events
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion needing drainage or related therapies within 2 weeks before enrollment
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected but not ruled out by imaging
- Prior treatment with topoisomerase I inhibitors including certain antibody-drug conjugates
- Prior participation or treatment with BNT323 in another study
- Prior treatment with PD-L1/VEGF bispecific antibodies (PD-1/VEGF bispecific antibodies, PD-1/PD-L1 inhibitors, or anti-VEGF therapies are allowed)
- Use of systemic immunostimulatory or immunosuppressive agents within 4 weeks before study treatment initiation, except certain corticosteroid uses
- Use of systemic corticosteroids above 10 mg/day prednisone or equivalent within 3 weeks before study treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Hematology - Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
Actively Recruiting
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
6
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Summit Medical Group
Florham Park, New Jersey, United States, 07932
Actively Recruiting
8
Memorial Sloan Kettering Hospital
New York, New York, United States, 10065
Actively Recruiting
9
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
10
Sunnybrook Health Sciences Centre
Toronto, Canada, M4N 3M5
Actively Recruiting
11
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China, 233004
Actively Recruiting
12
Jilin Cancer Hospital
Changchun, China, 130000
Actively Recruiting
13
Sichuan Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
14
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Actively Recruiting
15
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400016
Actively Recruiting
16
Huizhou First Hospital
Huizhou, China, 516003
Actively Recruiting
17
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China, 530021
Actively Recruiting
18
Fudan University Shanghai Cancer
Shanghai, China, 201315
Actively Recruiting
19
The Second Affiliated Hospital of Xi an Jiaotong University
Xi'an, China, 710004
Actively Recruiting
20
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France, 72000
Actively Recruiting
21
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
22
LLC Arensia Exploratory Medicine
Tbilisi, Georgia, 0112
Actively Recruiting
23
Institute of Oncology Arensia Exploratory Medicine
Chisinau, Moldova, 2025
Actively Recruiting
24
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye), 01140
Actively Recruiting
25
Adana City Hospital
Adana, Turkey (Türkiye), 01230
Actively Recruiting
26
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
27
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
28
Ankara City Hospital
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
29
Yeditepe Universitesi Kosuyolu Hastanesi
Istanbul, Turkey (Türkiye), 31755
Actively Recruiting
30
Koc University Hospital
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
31
IAU Medical Park Florya Hospital
Istanbul, Turkey (Türkiye), 34295
Actively Recruiting
32
Konya Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye), 42080
Actively Recruiting
33
Mersin City Education and Research Hospital
Mersin, Turkey (Türkiye), 33240
Actively Recruiting
34
Addenbrooke s Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
35
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
36
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
37
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
38
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
39
Royal Marsden Hospital-Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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