Context Therapeutics has dosed the first patient in a Phase 1 clinical trial for CT-95, a bispecific antibody targeting mesothelin-expressing cancers. This is the company’s second T cell engaging bispecific antibody to enter clinical trials this year, following CTIM-76 for Claudin 6-positive tumors. CT-95 targets mesothelin, a membrane protein overexpressed in an estimated 30% of cancers, offering a potential therapeutic avenue for advanced solid tumors like pancreatic, ovarian, and mesothelioma.
This clinical trial initiation is crucial because it demonstrates Context Therapeutics’ continued progress in developing targeted immunotherapies for solid tumors. Successfully targeting mesothelin, while navigating the challenge of shed mesothelin fragments, could represent a significant advancement in treating a wide range of difficult-to-treat cancers. The company’s parallel development of multiple T cell engaging bispecific antibodies further strengthens its position within the burgeoning field of immunotherapy and could lead to a diversified portfolio of treatment options.
The open-label, dose escalation and expansion study will evaluate CT-95’s safety and efficacy in patients with advanced solid tumors. The trial aims to assess tolerability, pharmacokinetics, and anti-tumor activity, including overall response rate, duration of response, and disease control rate. The initial dose escalation portion of the study is expected to enroll up to 30 patients, with preliminary data anticipated in mid-2026. CT-95 is designed to have a moderate affinity but high avidity for membrane-bound mesothelin, potentially mitigating the interference of shed mesothelin fragments.
The commencement of this Phase 1 trial is a positive step for Context Therapeutics. Positive clinical data could validate their approach to targeting mesothelin and pave the way for further clinical development. It will also contribute valuable insights into the efficacy and safety profile of T cell engaging bispecific antibodies in this patient population, potentially influencing future research and development efforts in the field.
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.
