NCT05227664

A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

Conditions

• Metastatic Triple-negative Breast Cancer
• Locally Advanced Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	AK117	Intravenous (IV) infusion
DRUG	AK112	Intravenous (IV) infusion
DRUG	Nab paclitaxel	Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
DRUG	paclitaxel	Paclitaxel at a starting dose of 90 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Timeline

• Start date: 2022-03-23
• Primary completion: 2026-12-30
• Completion: 2027-06-30
• First posted: 2022-02-07
• Last updated: 2026-03-16

Locations

2 sites across 1 country: China