Breakthrough in Cancer Treatment? Context Therapeutics Launches Phase 1 Trial for CLDN6-Targeted Therapy

Context Therapeutics

PHILADELPHIA, PAContext Therapeutics Inc. (Nasdaq: CNTX has announced that the first patient has been dosed in its Phase 1 clinical trial evaluating CTIM-76. This experimental treatment is a Claudin 6 (CLDN6) x CD3 T cell engaging bispecific antibody aimed at fighting CLDN6-positive gynecologic and testicular cancers.

The Phase 1 trial, which includes both dose escalation and expansion phases, seeks to assess the safety, tolerability, and efficacy of CTIM-76 in up to 70 patients. The primary focus will be on advanced or metastatic ovarian, endometrial, and testicular cancers that express the CLDN6 protein. Researchers will also evaluate the drug’s pharmacokinetics, as well as its impact on overall response rate, duration of response, and disease control rate.

“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. He emphasized the importance of recent data presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in selecting the trial’s initial dose and highlighted CTIM-76’s potential for treating CLDN6-positive cancers.

Chief Medical Officer Claudio Dansky Ullmann, M.D., added, “We look forward to advancing CTIM-76 toward target dose levels in 2025.”

Initial results from the Phase 1 trial are expected in the first half of 2026, marking an important step for Context Therapeutics in addressing unmet needs in cancer treatment.

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