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Thursday, April 2, 2026

FDA grants Fast Track to Context Therapeutics (CNTX) CTIM-76 in platinum-resistant ovarian cancer



Context Therapeutics Inc. reported that the FDA has granted Fast Track designation to CTIM-76, its investigational Claudin 6 x CD3 T cell engaging bispecific antibody, for treating platinum-resistant ovarian cancer in patients who have received all standard therapies.

CTIM-76 is being studied in a Phase 1 clinical trial in CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers, assessing safety, tolerability, pharmacokinetics and anti-tumor activity. The company expects interim Phase 1a data for CTIM-76 in June 2026, highlighting a near-term clinical milestone for this program.

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