Breast Cancer
Conditions
Brief summary
Phase I: Incidence and severity of AEs including dose limiting toxicities (DLTs), serious Adverse Events (SAEs), changes in laboratory parameters, vital signs and ECGs Tolerability: Dose interruptions, discontinuations, and reductions Phase II: ORR, CBR, TTR, DOR, PFS as per RECIST v1.1 by local investigator assessment Overall Survival (OS)
Detailed description
Phase I and II: ● Time activity curves (TACs) and absorbed radiation doses of [177Lu]Lu-NeoB in organs and tumor lesions ● Concentration of [177Lu]Lu-NeoB in blood over time and derived PK parameters, Phase I and II: ● Incidence and severity of adverse events following [68Ga]Ga-NeoB administration at screening, Phase I and II: ● Positive Percent Agreement (PPA) and Positive Predictive Agreement (PPrA) using conventional imaging as reference by central assessment, at screening, Phase I only: ● Visual assessment of image quality by central assessment, Phase I only: ● ORR, CBR, TTR, DOR, PFS as per RECIST v1.1 by local investigator assessment ● OS, Phase II only: ● Incidence and severity of AEs, SAEs, changes in laboratory parameters, vital signs and ECGs Dose interruptions, discontinuations, and reductions
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Incidence and severity of AEs including dose limiting toxicities (DLTs), serious Adverse Events (SAEs), changes in laboratory parameters, vital signs and ECGs Tolerability: Dose interruptions, discontinuations, and reductions Phase II: ORR, CBR, TTR, DOR, PFS as per RECIST v1.1 by local investigator assessment Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I and II: ● Time activity curves (TACs) and absorbed radiation doses of [177Lu]Lu-NeoB in organs and tumor lesions ● Concentration of [177Lu]Lu-NeoB in blood over time and derived PK parameters, Phase I and II: ● Incidence and severity of adverse events following [68Ga]Ga-NeoB administration at screening, Phase I and II: ● Positive Percent Agreement (PPA) and Positive Predictive Agreement (PPrA) using conventional imaging as reference by central assessment, at screening, Phase I only: ● Visual assessment of image quality by central assessment, Phase I only: ● ORR, CBR, TTR, DOR, PFS as per RECIST v1.1 by local investigator assessment ● OS, Phase II only: ● Incidence and severity of AEs, SAEs, changes in laboratory parameters, vital signs and ECGs Dose interruptions, discontinuations, and reductions | — |
Countries
France, Germany, Italy, Netherlands, Portugal, Spain
Outcome results
None listed