Cantargia has reported treatment of the first triple negative breast cancer (TNBC) patient with nadunolimab and chemotherapy in the phase Ib/II clinical trial TRIFOUR.
This trial, performed in collaboration with the Spanish Breast Cancer Group, GEICAM, will evaluate nadunolimab in combination with gemcitabine and carboplatin in up to 113 patients. Initially, the trial will focus on the safety of this combination and the first part is expected to be completed within 6-9 months.
“We are excited to reach this milestone and broaden the development of nadunolimab to include a new group of patients. TNBC is a rational choice for this expansion as it is a disease which is difficult to treat and is driven by biological mechanisms targeted by nadunolimab,” says Göran Forsberg, CEO of Cantargia.
The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab is Cantargia’s most advanced program and is investigated in multiple clinical trials. Approval to start the phase Ib/II clinical trial TRIFOUR, which evaluates nadunolimab combined with chemotherapy in TNBC, was recently obtained. The first patient has now started treatment in the TRIFOUR trial.
In the most advanced clinical programs, nadunolimab is evaluated in non-small cell lung cancer or pancreatic cancer patients in combination with chemotherapy. As these programs are advancing and have shown positive interim results, Cantargia’s goal is to gain a better understanding of the applicability of nadunolimab in other forms of cancer. For this reason, the clinical development of nadunolimab has been broadened to include other types of cancer, including TNBC, an aggressive and difficult to treat form of cancer that expresses IL1RAP at higher levels compared to other types of breast cancer.
In TRIFOUR, TNBC patients are treated with nadunolimab in combination with gemcitabine and carboplatin. The primary objective in the initial stage is to evaluate safety and tolerability of nadunolimab in combination with this chemotherapy regimen. Biomarkers and early signs of efficacy will also be evaluated at this stage. This part is estimated to be carried out over 6-9 months. If prespecified objectives are reached, the trial will be expanded into a randomized phase II part, which will investigate the efficacy of nadunolimab combination with gemcitabine and carboplatin in comparison to a control group receiving the same chemotherapy alone. The trial is estimated to include up to 113 patients at approximately 24 clinical centers in Spain. More information on the study can be found at clinicaltrials.gov (NCT05181462).
Photo of Göran Forsberg: Håkan Sandbring