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

Launched by BIONTECH SE · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for patients with advanced breast cancer, specifically looking at two investigational drugs called BNT323 and BNT327. The goal is to find the best dose of BNT323 when used together with BNT327, and to determine if this combination is safe and helpful for patients. The trial will include individuals who have certain types of breast cancer, including those with low levels of a protein called HER2, which is important for determining treatment options.

To participate, patients must have advanced or metastatic breast cancer that has been confirmed by lab tests. They should also have measurable disease, which means the cancer can be tracked for changes. However, there are some criteria that may exclude patients from joining, such as recent hospitalizations for bowel issues or ongoing health problems that could interfere with the study. If eligible, participants can expect to receive careful monitoring and support throughout the trial. It’s important to note that this trial is not yet recruiting participants, so further details will be shared when it begins.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):
• * Have pathologically documented BC that:
• • Is locally advanced, unresectable or metastatic.
• • Has a confirmed HER2 status as determined by the local laboratory (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.
• Key Exclusion Criteria:
• • 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 ADCs 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 previously been randomized to or received treatment in a previous study with BNT323, regardless of treatment assignment.
• • Participants who received prior treatment with a PD-L1/VEGF bispecific antibody. Note: Prior treatment with 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.
• • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.