Intensity Therapeutics, Inc. made the decision in March 2025 to pause new site activations and patient enrollments for its Phase 3 INVINCIBLE-3 sarcoma study. This action was taken due to funding constraints, requiring the company to prioritize its financial resources. Prior to this pause, the trial had enrolled 23 patients.
The company confirmed that it will continue to treat all patients already enrolled in the INVINCIBLE-3 study. This ensures continuity of care for existing participants while the company addresses its funding needs. Funding was specifically prioritized for the ongoing INVINCIBLE-4 Study.
The INVINCIBLE-3 study is a critical global randomized trial for soft tissue sarcoma, with overall survival as its primary endpoint. The pause in new enrollment represents a significant setback for the advancement of this lead program, highlighting the capital-intensive nature of late-stage clinical development.
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