other_material
confidence high
sentiment negative
materiality 0.75
CytomX reports Grade 5 adverse event in CX-2051 Phase 1 trial; FDA notified, study continues
CytomX Therapeutics, Inc.
- Single Grade 5 acute kidney injury occurred in patient with solitary kidney; event believed secondary to nausea, vomiting, diarrhea.
- Safety Review Committee convened July 14, 2025, supported continued study execution and enrollment.
- FDA notified on July 18, 2025; company aware on July 11, 2025.
- CX-2051 dose expansions at 7.2, 8.6, and 10 mg/kg each enrolled ~20 patients as planned.
- Phase 1 data update expected by Q1 2026.
item 8.01