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# Nuvation Bio Phase 1 Trial Hit with Clinical Hold
- URL: https://www.fdaweb.com/nuvation-bio-phase-1-trial-hit-with-clinical-hold/
- Published: 2022-06-27T12:00:00.000Z
- Updated: 2026-09-14T17:50:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152171

FDA has placed a partial clinical hold on a Nuvation Bio Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2-advanced breast cancer and metastatic castration-resistant prostate cancer. The trial began enrolling patients 12/2020, but in recent months as higher does were introduced the company says it began receiving reports of uveitis, an eye inflammation, in certain patients.

Nuvation says it paused enrollment of new patients to further assess the adverse events with investigators and uveitis experts, and it lso reached out to FDA for guidance on an appropriate path forward. “While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study,” it says. “Based upon the recent development of uveitis as a potential safety signal, we will conduct an overall risk/benefit analysis of the NUV-422 program.”