other material
confidence high
sentiment positive
materiality 0.75
Context Therapeutics reports 29% ORR for CTIM-76 in Phase 1 PROC trial; FDA Fast Track granted
Context Therapeutics Inc.
- 29% confirmed overall response rate per RECIST v1.1 in heavily pretreated PROC patients (median 7 prior lines).
- Cytokine Release Syndrome limited to Grade 1 in 11% of PROC patients at active doses; supports outpatient dosing.
- PK data supports exploration of Q3W dosing in 2H 2026; Phase 1b dose expansion planned for 2027.
- CTIM-76 granted FDA Fast Track Designation for platinum-resistant ovarian cancer.