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
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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 in combination with BNT327 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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Hematology - Oncology Associates of the Treasure Coast
RECRUITING
Port Saint Lucie
Michigan
START Midwest, LLC
RECRUITING
Grand Rapids
Texas
South Texas Accelerated Research Therapeutics (START), LLC
RECRUITING
San Antonio
Other Locations
China
Sichuan Cancer Hospital
RECRUITING
Chengdu
Huizhou First Hospital
RECRUITING
Huizhou
Fudan University Shanghai Cancer
RECRUITING
Shanghai
Georgia
LLC Arensia Exploratory Medicine
RECRUITING
Tbilisi
Republic of Moldova
Institute of Oncology Arensia Exploratory Medicine
Escalating dose levels (DLs) of BNT323 and BNT327 to define RP2D. Six DLs are planned, i.e., DL0-1, DL1-1, DL2-1, DL0-0, DL1-0, DL2-0, a combination of three different DLs for BNT323 (DL0, DL1, and DL2) and two DLs for BNT327 (DL0 and DL1).
Experimental: Part 2 Cohort 1 - RP2D of BNT323 + BNT327
Experimental: Part 2 Cohort 1 - Lower dose or RP2D of BNT323 + BNT327
Experimental: Part 2 Cohort 1 - BNT323 monotherapy
BNT323 monotherapy at a fixed dose
Experimental: Part 2 Cohort 1 - BNT327 monotherapy
BNT327 monotherapy at a fixed dose
Experimental: Part 2 Cohort 2 - Selected dose level of BNT323 + BNT327
Experimental: Part 2 Cohort 3 - Selected dose level of BNT323 + BNT327
Experimental: Part 2 Cohort 4 - Selected dose level of BNT323 + BNT327