Clinical TrialJun 15, 2026, 06:31 AM
Context Therapeutics CTIM-76 Shows 29% ORR in Ovarian Cancer Study
AI Summary
Context Therapeutics announced positive interim Phase 1 clinical data for its CLDN6 x CD3 T cell engaging bispecific antibody, CTIM-76, in advanced, late-line platinum-resistant ovarian cancer (PROC). The study demonstrated a 29% overall response rate (ORR) and a 57% disease control rate (DCR) in efficacy-evaluable PROC patients at active doses, with a favorable safety profile showing Grade 1 cytokine release syndrome (CRS) in only 11% of patients. The pharmacokinetic profile supports exploring a Q3W dosing schedule in the second half of 2026, with Phase 1b dose expansion anticipated in 2027. CTIM-76 has also received FDA Fast Track Designation for PROC.
Key Highlights
- 29% overall response rate (ORR) per RECIST v1.1 in platinum-resistant ovarian cancer (PROC) patients (2/7).
- 57% disease control rate (DCR) in PROC patients (4/7).
- PROC patients received a median of 7 prior lines of therapy (range 5-16).
- Cytokine Release Syndrome (CRS) was limited to Grade 1 in 11% of PROC patients (1/9).
- CTIM-76 has been granted FDA Fast Track Designation in PROC.
- Pharmacokinetic profile supports exploration of Q3W dosing in 2H 2026.
- Phase 1b dose expansion is expected in 2027.
- 21 patients with PROC, testicular, and endometrial cancer were treated in Phase 1a.
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