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
Trial status:Recruiting
Trial ID:
BNT323-03
NCT ID:
EudraCT ID:
N/A
EU Trial (CTIS) Number:
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
DualityBio Inc., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Recruiting
Trial Details
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 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) 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).
Medical Condition
Breast Cancer
Study Drug
BNT323
See more
BNT327
Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
380
Estimated Trial Date
Apr 2025 - May 2028
Trial Participant Requirements
Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria
Exclusion criteria
- Have pathologically documented BC that:
- Is locally advanced, unresectable or metastatic.
- Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample.
- Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology/College of American Pathologists guidelines.
- Have measurable disease defined by RECIST v1.1.
- Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment.
- Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.
- 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, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment.
- 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.
- Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan.
- Have received any of the following therapies or drugs prior to the initiation of the study:
- Participants who have received prior treatment with BNT323.
- Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) / vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)/VEGF bispecific antibodies, PD-1/PD-L1 inhibitors or anti-VEGF therapies are permitted.
- Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).
- Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment.
Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Trial Locations
Location
Status
Location
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Status
Recruiting
Location
Hematology - Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
Status
Recruiting
Location
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
Status
Recruiting
Location
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Status
Recruiting
Location
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Status
Recruiting
Location
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Status
Recruiting
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