Context Therapeutics Inc. announced that the FDA granted Fast Track designation to its investigational drug CTIM-76 for platinum-resistant ovarian cancer, with interim Phase 1a trial data expected in June 2026.
Key takeaways
FDA granted Fast Track designation to CTIM-76 for platinum-resistant ovarian cancer in patients who have received all standard of care therapies.
CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody currently in a Phase 1 clinical trial for CLDN6-positive advanced or metastatic cancers.
Interim data from the CTIM-76 Phase 1a trial is expected in June 2026, which will evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity.
The Fast Track designation is designed to expedite development and review timelines for drugs treating serious conditions with unmet medical needs.
CTIM-76 targets CLDN6, which is enriched in various solid tumors including ovarian, endometrial, lung, gastric, and testicular cancers.