Context Therapeutics Inc. announced positive interim efficacy and safety results from its ongoing Phase 1 clinical trial of CTIM-76, its investigational Claudin 6 x CD3 T cell engaging bispecific antibody. The data, from a May 29, 2026 cutoff, showed promising anti-tumor activity and a favorable safety profile in heavily pretreated patients with advanced platinum-resistant ovarian cancer (PROC).
Key Details
- Efficacy: The trial demonstrated a 29% confirmed Overall Response Rate (ORR) and a 57% Disease Control Rate (DCR) in evaluable PROC patients. These patients were heavily pretreated, having received a median of 7 prior lines of therapy.
- Safety Profile: CTIM-76 was observed to be well-tolerated. Cytokine Release Syndrome (CRS) events in PROC patients were infrequent and limited to Grade 1 (11% of patients), with no Grade 2 or higher CRS reported.
- Regulatory & Next Steps: The FDA has granted Fast Track Designation to CTIM-76 for this indication. The drug's pharmacokinetic profile supports exploring an every-three-week (Q3W) dosing schedule, which will begin evaluation in the second half of 2026.