Cantargia has announced the submission of the clinical trial application for TRIFOUR, a phase Ib/II trial investigating nadunolimab (CAN04) combined with gemcitabine and carboplatin for treatment of triple negative breast cancer (TNBC).
After an initial safety lead in, the study will include a randomized phase II part. This trial will be performed in Spain in collaboration with the Spanish Breast Cancer Group, GEICAM.
Up to 120 patients may be included and the first patient is estimated to be enrolled in November 2021.
The clinical trial application for the company’s fifth study, called TRIFOUR, has now been submitted to the regulatory authorities in Spain. This study will be conducted in collaboration with GEICAM and the submission follows the previously communicated letter of intent with GEICAM.
TRIFOUR is a phase Ib/II trial designed to evaluate CAN04 in combination with gemcitabine and carboplatin as first or second line treatment in patients with advanced 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.
The primary objective in the initial stage is to evaluate the safety and tolerability of CAN04 in combination with this chemotherapy regimen. Biomarkers and early signs of efficacy will also be evaluated at this stage.
“The development of nadunolimab is advancing with this study investigating nadunolimab in triple negative breast cancer.”
If prespecified milestones are reached in the initial open label part, the trial will be expanded into a randomized phase II part, to investigate the efficacy of CAN04 combination with gemcitabine and carboplatin, compared to a control group receiving gemcitabine and carboplatin alone.
“The development of nadunolimab is advancing with this study investigating nadunolimab in triple negative breast cancer. It is a disease of high relevance for our therapeutic approach and this study is the first controlled trial we perform to verify the positive effects observed in other inflammatory-driven cancer forms,” says Göran Forsberg, CEO of Cantargia.
Photo of Göran Forsberg