NCT06767527

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

A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Plus Nab-paclitaxel Versus Placebo Plus Nab-paclitaxel as First-line Treatment for Locally Advanced Unresectable or Metastatic Triple-negative Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Triple-Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	AK112	AK112 via intravenous (IV) infusion
DRUG	Nab-paclitaxel	Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
DRUG	Placebo	Placebo via IV infusion

Timeline

• Start date: 2025-02-07
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2025-01-10
• Last updated: 2026-03-16

Locations

1 site across 1 country: China