NEW YORK – Context Therapeutics on Wednesday said it began treating patients in a Phase I trial of its claudin 6 (CLDN6)- and CD3 T-cell-engaging bispecific antibody, CTIM-76, in CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer.
The trial will include up to 80 patients in the dose escalation and dose expansion portions. The dose escalation stage will evaluate nine dose cohorts, and the dose expansion will evaluate two doses in 30 participants. Researchers will also assess the overall response rate on CTIM-76. Context expects to report initial data for the CTIM-76 Phase I trial in the first half of 2026.
Philadelphia-based Context has two other bispecific antibodies in preclinical development, including CT-95, a mesothelin x CD3 bispecific antibody, and CT-202, a nectin-4 x CD3 bispecific antibody. The company acquired CT-95 from Link Immunotherapeutics in July 2024 and expects to begin a Phase I trial in Q1 2025.
The firm was previously studying a progesterone receptor antagonist in clinical trials but ended development in March 2023 to focus resources on CTIM-76.