drugset / Trial / NCT07103447

Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC

NCT07103447

Phase 2 Not yet recruiting 54 enrolled Shuangyue Liu
NaSingle-groupOpen-labelTreatment

Summary

This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally advanced TNBC.

Timeline

Start
2025-09-10
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule
Subject Ivonescimab Monoclonal antibody
Subject Paclitaxel Small molecule