Context Therapeutics Inc. (Nasdaq: CNTX) has announced the dosing of the first patient in its Phase 1 clinical trial of CTIM-76, a Claudin 6 (CLDN6) x CD3 T cell engaging bispecific antibody. The trial is designed for patients with CLDN6-positive gynecologic and testicular cancers and marks a significant step in advancing Context Therapeutics' clinical pipeline.
The Phase 1 trial is an open-label, dose escalation and expansion study. It aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CTIM-76 in patients with advanced or metastatic ovarian, endometrial, and testicular cancers expressing CLDN6. The study plans to enroll up to 70 patients, with initial data expected in the first half of 2026.
CTIM-76: A Novel Bispecific Antibody
CTIM-76 is designed as a CLDN6 x CD3 T cell engaging bispecific antibody. Claudin 6 (CLDN6) is a protein enriched in various solid tumors, including ovarian, endometrial, lung, gastric, and testicular cancers. Preclinical research indicates that CTIM-76 has the potential for convenient dosing, low immunogenicity risk, and scalable manufacturing, making it a promising therapeutic candidate for a substantial number of patients.
Management Commentary
"Dosing of the first patient in the CTIM-76 Phase 1 trial represents a key advancement of our clinical pipeline," said Martin Lehr, CEO of Context Therapeutics. He also noted the supportive data presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which influenced the selection of the first-in-human dose.
Claudio Dansky Ullmann, M.D., Chief Medical Officer of Context, added, "We look forward to advancing CTIM-76 toward target dose levels in 2025."
Trial Objectives and Design
The Phase 1 trial includes dose escalation and dose expansion phases. These phases will assess safety, tolerability, and pharmacokinetics, along with anti-tumor activity measured by overall response rate, duration of response, and disease control rate.
About Context Therapeutics
Context Therapeutics Inc. is a biopharmaceutical company focused on advancing T cell engaging bispecific antibodies for solid tumors. Their pipeline includes CTIM-76 (CLDN6 x CD3 bispecific antibody), CT-95 (Mesothelin x CD3 bispecific antibody), and CT-202 (Nectin-4 x CD3 bispecific antibody). The company is headquartered in Philadelphia.
