Intensity Therapeutics, Inc. announced that the first U.S. patient has been dosed in the Company's Phase 3 study to treat metastatic sarcoma (NCT06263231). Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,337 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.

The global Phase 3 study is expected to enroll approximately 333 patients. The primary endpoint is overall survival. For every three patients treated, two will receive INT230-6, and one will receive the standard ofcare.

STS subtypes being enrolled are leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma. The Phase 3 initiation follows reported data from the Company's Phase 1/2 trial, where INT230-6 showed tumor-killing and immune-activating properties with increased survival in metastatic disease.