Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK announced the dosing of the first patient in the INVINCIBLE-4 Study on October 31, 2024. This Phase 2 trial is designed to treat patients with localized triple-negative breast cancer (TNBC). The study aims to evaluate the efficacy and safety of INT230-6 when combined with standard-of-care versus standard-of-care alone.
The INVINCIBLE-4 Study is a randomized, open-label, multicenter trial expected to enroll approximately 54 patients across Switzerland and France. Its primary endpoint is the pathological complete response (pCR) rate in the primary tumor and affected lymph nodes. Patients will be randomized to receive either two doses of INT230-6 followed by standard-of-care or standard-of-care alone.
This milestone follows data from the INVINCIBLE-2 Study, where INT230-6 alone demonstrated tumor-killing properties at levels greater than 95% with a single intratumoral dose and systemic immune activation. The initiation of this Phase 2 study represents a significant step in addressing the unmet need for aggressive TNBC subtypes.
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