Actively Recruiting
A Phase I/II Multi-site Open-label Trial to Evaluate the Safety, Efficacy, and Optimal Dose of BNT323 Combined With BNT327 in Participants With Advanced Breast Cancer
Led by BioNTech SE · Updated on 2026-05-15
380
Participants Needed
41
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
D
DualityBio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and optimal dosing of two investigational treatments, BNT323 (trastuzumab pamirtecan) and BNT327 (pumitamig), in people with advanced breast cancer. This includes various types of breast cancer such as hormone receptor-positive or negative, HER2-positive, HER2-low, HER2-ultralow, HER2-null, and triple-negative breast cancer. The study is a Phase I/II trial conducted at multiple sites and aims to understand how these treatments work together and their safety profiles. The study has two parts. Part 1 involves dose escalation where participants with certain types of advanced breast cancer receive increasing doses of the combination of BNT323 and BNT327 to find the recommended dose for further study. Part 2 expands to test this optimal dose and includes four groups, with one group randomly assigned to one of four treatment arms: combination therapy at the recommended dose, combination therapy, BNT323 alone, or BNT327 alone. Some groups receive fixed doses while others explore different doses and combinations. Participants will receive treatments via intravenous infusion and undergo regular tumor scans and safety assessments for up to 36 months. Researchers will monitor for side effects, treatment-related complications, and tumor response. They will also track treatment interruptions or dose changes due to side effects. The study includes careful heart function checks before starting treatment and continuous safety monitoring during and after therapy to evaluate overall treatment impact.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Have pathologically confirmed locally advanced, unresectable, or metastatic breast cancer
- Confirmed HER2 status from recent tumor sample as per guidelines
- Measurable disease defined by RECIST v1.1
- Left ventricular ejection fraction of 55% or higher within 28 days before enrollment
You will not qualify if you...
- History of small bowel obstruction requiring hospitalization within 3 months prior to first treatment dose
- Uncontrolled illnesses that limit study compliance or increase risk of adverse events
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring intervention within 2 weeks prior to 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 trastuzumab deruxtecan
- Prior treatment with BNT323 or PD-L1/VEGF bispecific antibodies
- Use of systemic immunostimulatory or immunosuppressive therapies within 4 weeks before study treatment except some corticosteroids
- Use of systemic corticosteroids above 10 mg/day prednisone (or equivalent) within 3 weeks before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of dose escalation period as per protocol
Participants receive escalating doses of BNT323 combined with BNT327 to determine the optimal dose for further study.
Multiple visits during dose escalation cycles
Duration - Up to 36 months of treatment and assessments
Participants receive the recommended Phase 2 dose (RP2D) of BNT323 and BNT327 combination or monotherapy in randomized or non-randomized cohorts to evaluate safety and efficacy.
Visits scheduled according to treatment cycles and tumor assessment scans
Duration - Up to 90 days after last dose
Participants are monitored for safety and treatment outcomes after completion of active treatment.
Visits for safety monitoring post-treatment
Trial Site Locations
Total: 41 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
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
Actively Recruiting
4
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Summit Medical Group
Florham Park, New Jersey, United States, 07932
Actively Recruiting
9
Memorial Sloan Kettering Hospital
New York, New York, United States, 10065
Actively Recruiting
10
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
11
Sunnybrook Health Sciences Centre
Toronto, Canada, M4N 3M5
Actively Recruiting
12
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China, 233004
Actively Recruiting
13
Jilin Cancer Hospital
Changchun, China, 130000
Actively Recruiting
14
Sichuan Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
15
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Actively Recruiting
16
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400016
Actively Recruiting
17
Huizhou First Hospital
Huizhou, China, 516003
Actively Recruiting
18
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China, 530021
Actively Recruiting
19
Fudan University Shanghai Cancer
Shanghai, China, 201315
Actively Recruiting
20
The Second Affiliated Hospital of Xi an Jiaotong University
Xi'an, China, 710004
Actively Recruiting
21
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France, 72000
Actively Recruiting
22
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
23
LLC Arensia Exploratory Medicine
Tbilisi, Georgia, 0112
Actively Recruiting
24
IEO Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
25
Institute of Oncology Arensia Exploratory Medicine
Chisinau, Moldova, 2025
Actively Recruiting
26
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye), 01140
Actively Recruiting
27
Adana City Hospital
Adana, Turkey (Türkiye), 01230
Actively Recruiting
28
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
29
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
30
Ankara City Hospital
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
31
Yeditepe Universitesi Kosuyolu Hastanesi
Istanbul, Turkey (Türkiye), 31755
Actively Recruiting
32
Koc University Hospital
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
33
IAU Medical Park Florya Hospital
Istanbul, Turkey (Türkiye), 34295
Actively Recruiting
34
Konya Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye), 42080
Actively Recruiting
35
Mersin City Education and Research Hospital
Mersin, Turkey (Türkiye), 33240
Actively Recruiting
36
Addenbrooke s Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
37
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
38
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
39
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
40
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
41
Royal Marsden Hospital-Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
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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