CT-95 (mesothelin)
- Indication
- Solid tumors
- Stage
- phase1
- Event
- Initial Data
- Details
Nov. 7, 2025: Context Therapeutics Inc. (NASDAQ: CNTX) presented two posters at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting (Nov. 7–9, 2025) covering its bispecific T cell engager (TCE) programs CT-95 and CT-202 for solid tumors.
CT-95 (mesothelin x CD3 bispecific TCE): Ongoing Phase 1 trial (NCT06756035) with 6 patients enrolled as of Oct. 30, 2025. The study is enrolling Cohort 3 (priming dose 0.18 µg/kg; full dose 0.6 µg/kg). The company projects target dose exposure starting at Cohort 4 based on preclinical data. Safety to date: no cytokine release syndrome (CRS) > Grade 2, no dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) not reached; dose escalation continues. Initial Phase 1a data are anticipated mid-2026.
CT-202 (Nectin-4 x CD3 bispecific TCE): Preclinical data showed potent activity with favorable pharmacokinetic and safety profile; designed as a pH-dependent TCE to be preferentially active in the tumor microenvironment. Context expects to complete regulatory filings to support first-in-human trial initiation in Q2 2026.
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