Context Therapeutics has dosed the first patient in a Phase 1 clinical trial for CTIM-76, a T cell engager bispecific antibody targeting Claudin 6 (CLDN6)-positive gynecologic and testicular cancers. The trial is designed to evaluate the safety and efficacy of CTIM-76, with initial data expected in the first half of 2026. This trial marks a significant step forward in the company’s clinical pipeline development.
This first-in-human trial of CTIM-76 is crucial for advancing the treatment of CLDN6-positive cancers. CLDN6 is often overexpressed in various solid tumors, offering a promising target for T cell engager therapies. Positive trial results could validate CLDN6 as a viable therapeutic target and potentially offer a new treatment option for patients with these difficult-to-treat cancers. This could pave the way for further development of CTIM-76 and establish Context Therapeutics as a leader in this specific therapeutic area.
The Phase 1 trial is an open-label study evaluating CTIM-76 in patients with advanced or metastatic ovarian, endometrial, and testicular cancers. The trial will assess safety, tolerability, pharmacokinetics, and anti-tumor activity. Up to 70 patients are expected to be enrolled in the dose-escalation and expansion phases. Preclinical research suggests the potential for convenient dosing, low immunogenicity risk, and scalable manufacturing for CTIM-76.
The initiation of this Phase 1 trial sets the stage for potentially significant progress in the development of CTIM-76. Successful results could lead to subsequent clinical trials and eventually, regulatory approval, providing a much-needed therapeutic option for patients with CLDN6-positive cancers. This trial also strengthens Context Therapeutics’ position in the field of T cell engager therapies for solid tumors.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
