Clinical Trial

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

Recruiting Phase 3
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-08.
Status change: Not Yet Recruiting → Recruiting 2026-03-13
Trial Details
NCT Number NCT06767527
Lead Sponsor Akeso
Conditions Triple-Negative Breast Cancer (TNBC)
Enrollment 416 participants
Start Date 2025-02-07
Primary Completion 2026-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-16