drugset / Trial / NCT06419621

PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

NCT06419621

Phase 3 Recruiting 360 enrolled BioNTech SE
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)

Timeline

Start
2024-06-11
Primary completion
2027-07
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Pumitamig Protein / enzyme biologic 20 mg/kg Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous