Clinical TrialJun 15, 2026, 09:22 AM
Context Therapeutics: CTIM-76 Shows 29% ORR in Phase 1 Ovarian Cancer Trial
AI Summary
Context Therapeutics Inc. announced positive interim efficacy and safety results from its ongoing Phase 1 clinical trial for CTIM-76, an investigational Claudin 6 x CD3 T cell engaging bispecific antibody. The data, from advanced, late-line platinum-resistant ovarian cancer (PROC) patients, showed a 29% confirmed overall response rate and a 57% disease control rate. The drug demonstrated a favorable safety profile with limited Grade 1 Cytokine Release Syndrome (CRS). CTIM-76 has received FDA Fast Track Designation, and the company plans to explore a Q3W dosing schedule.
Key Highlights
- Context Therapeutics announced positive interim Phase 1 data for CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody.
- In platinum-resistant ovarian cancer (PROC) patients, CTIM-76 showed a 29% confirmed overall response rate (ORR) per RECIST v1.1.
- The disease control rate (DCR) was 57% in efficacy-evaluable PROC patients.
- Cytokine Release Syndrome (CRS) was limited to Grade 1 in 11% of PROC patients at active dose levels.
- CTIM-76 has received FDA Fast Track Designation for PROC.
- The company plans to evaluate CTIM-76 on a Q3W dosing schedule in 2H 2026.
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