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
A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer
Sponsor: BioNTech SE + DualityBio Inc., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Part 1 - Occurrence of dose limiting toxicities (DLTs)
Time frame: During the DLT evaluation period (Cycle 1), i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days
Occurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs
Time frame: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose
Occurrence of dose interruption, reduction, and discontinuation due to TEAEs
Time frame: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose
Part 2 - Objective response rate (ORR)
Time frame: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.
Secondary Endpoints
Part 1 - ORR
Part 2 - Duration of response (DoR)
Part 2 - Disease control rate (DCR)
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 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. Key Exclusion Criteria: * Have history of small bowel obstruction r…
Read full criteria on CT.gov →✦ Analyst Commentary
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