Context Therapeutics Advances CTIM-76 Into Phase 1 Clinical Trial

Context Therapeutics Inc., a biopharma company focused on T cell engager therapies for solid tumours, has announced a key milestone: The first patient has now been dosed in their Phase 1 trial with CTIM-76. This novel construct is a bispecific antibody that binds to CLDN6 and CD3 to invoke the action of T cells. Currently, the trial is recruiting patients with CLDN6-positive gynecologic and testicular cancers; the outcome is expected in the first half of this year, 2026.

The study is meant to be an open-label study on safety, tolerability, and signal of efficacy in patients with advanced or metastatic ovarian, endometrial, and testicular carcinomas. Outcomes that researchers will assess include the rate of response, duration of response, and disease confined. From 35 to 70 patients will be enrolled in this critical dose escalation and expansion study. 

“Dosing of the first patient in the CTIM-76 Phase 1 trial represents a key advancement of our clinical pipeline. We recently presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), supporting the selection of this first-in-human dose and highlighting the potential of CTIM-76 to treat CLDN6-positive cancers,” said Martin Lehr, CEO of Context.

“We look forward to advancing CTIM-76 toward target dose levels in 2025," commented Claudio Dansky Ullmann, M.D., Chief Medical Officer of Context.

The study is meant to be an open-label study on safety, tolerability, and signal of efficacy in patients with advanced or metastatic ovarian, endometrial and testicular carcinomas. Outcomes that researchers will assess include the rate of response, duration of response, and disease confined. Up to 70 patients will be enrolled in this critical dose escalation and expansion study.