Locally Advanced Breast Cancer study: BNT323 vs BNT327
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
ClinicalTrials.gov ID: NCT06827236
What this study is testing
What is BNT323?
This is an investigational medicine being studied as a potential treatment for locally advanced breast cancer. It is designed to attach to HER2 proteins on cancer cells and deliver a chemotherapy drug directly to them.
Also referred to as trastuzumab pamirtecan, DB-1303.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the combination of BNT323 and BNT327 is safe and may help treat advanced breast cancer, and to find the best dose.
- Who it's for
- It looks for adults with locally advanced, unresectable, or metastatic breast cancer, including various HER2 and hormone receptor subtypes.
- What's involved
- Participants will receive the investigational drugs and have regular visits for medical checks and tests to monitor safety and effectiveness.
- Time commitment
- The study lasts about 2 years, with multiple clinic visits and tests throughout the treatment period.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or...
- 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...
You likely can't join if
- 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...
- Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated...
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where...
- Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab...
- Participants who have received prior treatment with BNT323.
See the full eligibility criteria
- 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...
- 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...
- 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. Key
- 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.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Beverly Hills, California, United States
- Newport Beach, California, United States
- Port Saint Lucie, Florida, United States
- Athens, Georgia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Basking Ridge, New Jersey, United States
- Florham Park, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Harrison, New York, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Uniondale, New York, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
+ 45 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beverly Hills, California, United States; Newport Beach, California, United States; Port Saint Lucie, Florida, United States; Athens, Georgia, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 59 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.