RecruitingPhase 3NCT06767527

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


Sponsor

Akeso

Enrollment

416 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing AK112 — a drug that simultaneously blocks both PD-1 (an immune checkpoint) and VEGF (a protein that helps tumors grow blood vessels) — combined with nab-paclitaxel chemotherapy as a first-line treatment for triple-negative breast cancer that cannot be surgically removed or has spread. **You may be eligible if...** - You have been diagnosed with unresectable locally advanced or metastatic triple-negative breast cancer (ER-negative, PR-negative, and HER2-negative) - You have not previously received systemic treatment for advanced breast cancer - You are between 18 and 75 years old - Your general health is good (ECOG score 0 or 1) - You have at least one measurable tumor lesion - You are suitable for taxane-based single-agent chemotherapy **You may NOT be eligible if...** - You have received prior chemotherapy for advanced disease - Your cancer is locally recurrent and can still be surgically removed or treated with radiation - You have serious organ dysfunction or active infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK112

AK112 via intravenous (IV) infusion

DRUGNab-paclitaxel

Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle

DRUGPlacebo

Placebo via IV infusion


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

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NCT06767527