TRIFOUR

TRIFOUR

TRIFOUR is a phase Ib/II clinical trial which investigates nadunolimab (CAN04) in combination with carboplatin and gemcitabine for treatment of triple-negative breast cancer (TNBC). TNBC is an aggressive and difficult to treat form of breast cancer that expresses IL1RAP at higher levels than other forms of breast cancer. TRIFOUR is performed in Spain in collaboration with the Spanish Breast Cancer Group, GEICAM, and may include up to 113 patients.

The primary objective in the initial dose-escalation stage is to evaluate the safety and tolerability of CAN04 in combination with the chemotherapy regimen. The dose-escalation stage was completed in February 2023 and 15 first- or second-line patients with metastatic TNBC were enrolled. The combination showed an acceptable safety profile, and initial efficacy data showed promising responses compared to historical control data.

The trial has now expanded into the randomized phase II part which may include up to 98 additional patients. In this stage, the combination of CAN04 with carboplatin and gemcitabine will be compared to a control group given chemotherapy only. Top-line analysis for the complete trial is planned after full recruitment, estimated late 2024 or early 2025.

Read more about TRIFOUR on ClinicalTrials.gov (NCT05181462).