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

Name: AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer — clinical trial record (NCT06767527)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorAkeso

Started2025-02-07

View on ClinicalTrials.gov ↗

Amendment history

2026-03-13

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-01→confirmed 2025-02-07

Study sitesdetails revised at 1 of 1 site

2025-01-08

Original filing

Akeso

96 trials monitored

See 1 trial at risk

Breast Cancer

5,180 trials monitored

See 256 trials at risk

Triple-Negative Breast Cancer

594 trials monitored

See 37 trials at risk

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).

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