Core Insights - Intensity Therapeutics is presenting its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for metastatic soft tissue sarcomas at the ASCO 2025 Annual Meeting [1][2] - The trial aims to compare the efficacy and safety of INT230-6 with standard systemic chemotherapy in adults with locally recurrent, inoperable, or metastatic soft tissue sarcomas [2][6] Company Overview - Intensity Therapeutics is a late-stage clinical biotechnology company focused on developing immune-based intratumoral cancer therapies [1][9] - The lead investigational product, INT230-6, combines cisplatin and vinblastine with a penetration enhancer to improve drug distribution within tumors [5][9] - The company has completed two clinical studies with over 200 patients enrolled, demonstrating the potential of INT230-6 to elicit an adaptive immune response [9] Clinical Trial Details - The INVINCIBLE-3 trial is a multicenter, randomized, global Phase 3 study assessing INT230-6 as a monotherapy compared to standard care [2][6] - Participants will be randomized in a 2:1 ratio to receive either INT230-6 or standard chemotherapy agents [6] - The trial includes specific inclusion and exclusion criteria to ensure appropriate patient selection [7][8] Previous Study Results - In earlier studies, patients with refractory metastatic sarcoma showed a disease control rate of 93% and a median overall survival of 21.3 months with minimal adverse events [4] - The Phase 1/2 trial indicated immune engagement and regression of uninjected tumors post-treatment [4] Future Plans - The company has paused new enrollment for the Phase 3 study until additional funding is secured, while continuing to treat enrolled patients [4]