On March 14, 2023 Cantargia (Cantargia AB) (Nasdaq Stockholm: CANTA) reported that, following positive results in the lead-in phase of the clinical phase Ib/II trial TRIFOUR, the first triple-negative breast cancer (TNBC) patient has initiated treatment with the IL1RAP-binding antibody nadunolimab (CAN04) and chemotherapy in the phase II randomized part of the trial (Press release, Cantargia, MAR 14, 2023, View Source [SID1234628719]). Up to 98 patients may be included in this part and the next milestone, an interim futility analysis of 28 patients, is estimated in Q4 2023.
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"We are proud to have started Cantargia’s first randomized trial with nadunolimab, in patients with triple-negative breast cancer, shortly after presenting an early signal of efficacy in this type of patients. This marks good progress as nadunolimab continues to demonstrate potential to make a significant difference in treatment of cancer," said Göran Forsberg, CEO of Cantargia.
The initial dose-escalation stage of TRIFOUR was recently finalized where an acceptable safety and early signs of efficacy were reported for the combination therapy. The preliminary response rate of 50%, including one complete response in 12 patients, indicates an improvement compared to historical control data for chemotherapy alone.
In the open-label phase II stage of TRIFOUR, first or second-line patients with advanced TNBC will be randomized in a 1:1 ratio to either a control arm where the chemotherapy doublet of gemcitabine and carboplatin is given alone, or an investigational therapy arm where nadunolimab is also administered. The primary objective is to investigate antitumor activity. The TRIFOUR trial is conducted in collaboration with the Spanish Breast Cancer Group (GEICAM).
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]
This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 11.40 CET on 14 March 2023.