Context Therapeutics Doses First Patient in CTIM-76 Phase 1 Trial

Context Therapeutics Inc., a biopharmaceutical enterprise headquartered in Philadelphia, has commenced a pivotal phase in the development of its therapeutic pipeline by dosing the first patient in its CTIM-76 Phase 1 clinical trial. This trial is exploring the potential of a novel bispecific antibody designed to target gynecologic and testicular cancers characterized by Claudin 6 (CLDN6) positivity. The company anticipates releasing initial data from this study in the first half of 2026.

Martin Lehr, CEO of Context Therapeutics, emphasized the significance of this development, highlighting the trial as a crucial step forward in their clinical endeavors. Lehr's comments followed a recent presentation at the Society for Immunotherapy of Cancer's 39th Annual Meeting, which underscored the rationale for selecting the first-in-human dose and the promising therapeutic potential of CTIM-76 for CLDN6-positive cancers.

The CTIM-76 Phase 1 trial is structured as an open-label, dose escalation and expansion study. It aims to assess the safety and effectiveness of the CTIM-76 bispecific antibody in patients suffering from advanced or metastatic ovarian, endometrial, and testicular cancers that express the CLDN6 protein. The trial is set to evaluate critical factors such as safety, tolerability, and pharmacokinetics, alongside measuring anti-tumor efficacy through overall response rate, duration of response, and disease control rate. The study plans to enroll up to 70 participants.

Claudio Dansky Ullmann, M.D., Chief Medical Officer at Context, expressed optimism about advancing CTIM-76 to the targeted dose levels within the year 2025. This endeavor marks a significant milestone in efforts to address the unmet medical needs of patients with CLDN6-positive tumors.

CTIM-76 operates by engaging T cells through its CLDN6 x CD3 bispecific antibody structure. The protein CLDN6 is notably present in a variety of solid tumors, such as those found in ovarian, endometrial, lung, gastric, and testicular cancers. Preclinical studies suggest that CTIM-76 offers the potential advantages of convenient dosing, reduced risk of immunogenicity, and scalable production, which could benefit a substantial number of patients eligible for this therapy.

Context Therapeutics is dedicated to advancing T cell engaging therapies, with CTIM-76 being a prominent component of their innovative portfolio. Other promising therapeutics in their pipeline include CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. These developments underscore the company’s commitment to tackling solid tumors with cutting-edge bispecific antibody technology.

The initiation of the CTIM-76 Phase 1 trial marks an encouraging step in the journey to develop new treatment options for patients with challenging cancer types characterized by CLDN6 expression. Context Therapeutics continues to pursue its mission of delivering effective therapies through its robust research and clinical development efforts, reflecting a significant leap forward in cancer treatment innovation.