Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06767527
PHASE3

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

Sponsor: Akeso

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

416

Start Date

2025-02-07

Completion Date

2028-12

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

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

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China