Up to 70 subjects are anticipated to be enrolled in the trial. Credit: New Africa/Shutterstock.

Context Therapeutics has dosed the first subject in the Phase I trial of CTIM-76, targeting claudin 6 (CLDN6)-positive gynaecologic and testicular cancers.

The open-label trial aims to assess the efficacy and safety of the CLDN6 x cluster of differentiation 3 (CD3) T cell engaging bispecific antibodies, with initial data expected to be shared in the first half of 2026.

Aiming to enrol up to 70 subjects, the dose escalation and expansion parts of the trial will assess the safety, efficacy, and pharmacokinetics of the therapy, as well as its anti-tumour activity through duration of response, disease control rate, and overall response rate.

The trial will focus on subjects with advanced or metastatic ovarian, endometrial, and testicular cancer that are CLDN6-positive.

In preclinical research, the therapy has shown its potential for ‘convenient’ dosing, low immunogenicity risk, and scalable manufacturing, making it potentially suitable for a significant patient population, the company noted.

In May last year, the US Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for the therapy. This approval facilitated the commencement of the Phase I trial that focused on CLDN6-positive gynaecologic and testicular cancers.

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Context Therapeutics CEO Martin Lehr said: “Dosing of the first patient in the CTIM-76 Phase I 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.”

Headquartered in Philadelphia, Context Therapeutics is a biopharmaceutical company developing a portfolio of T-cell engaging bispecific antibodies for treating solid tumours, including the Mesothelin x CD3 bispecific antibody CT-95, and the Nectin-4 x CD3 bispecific antibody CT-202.