drugset / Trial / NCT06767527

AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

NCT06767527

Phase 3 Recruiting 416 enrolled Akeso
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).

Timeline

Start
2025-02-07
Primary completion
2026-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivonescimab Monoclonal antibody Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous