Context Therapeutics’ CTIM-76 Gains FDA Fast Track, Interim Data Due June 2026
Context Therapeutics’ bispecific antibody CTIM-76 received FDA Fast Track Designation for treating platinum-resistant ovarian cancer in patients after standard therapies. A Phase 1a dose-escalation trial is underway, with interim safety and efficacy data expected in June 2026.
1. Fast Track Designation Awarded
The FDA granted Fast Track Designation to CTIM-76, a CLDN6×CD3 T cell engaging bispecific antibody, based on its potential to address platinum-resistant ovarian cancer in patients who have exhausted standard therapies. This status enables more frequent interactions with regulators and eligibility for rolling submissions to expedite development timelines.
2. Ongoing Phase 1a Clinical Trial
Context Therapeutics initiated a Phase 1a dose-escalation and expansion trial to evaluate CTIM-76’s safety, tolerability, pharmacokinetics and anti-tumor activity by overall response rate, duration of response and disease control rate in CLDN6-positive advanced ovarian, endometrial and testicular cancers.
3. Upcoming Data Readout and Outlook
Interim safety and efficacy results from the Phase 1a trial are expected in June 2026. Positive outcomes could accelerate CTIM-76’s clinical development and strengthen Context’s portfolio of T cell engaging bispecific antibodies for solid tumors.