Clinical Trial

A First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors

Recruiting Phase 1
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Summary
ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor. This multicenter, open-label, first-in-human Phase 1 study will evaluate ZE94-0605 in adults with advanced, unresectable or metastatic solid tumors. Phase 1a will use sequential dose escalation to determine the maximally tolerated dose and biologically effective dose. Phase 1b will randomize participants with CCNE1 amplification, or another prospectively specified molecular feature, between two dose levels to select the recommended Phase 2 dose.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-07-30
critical Primary endpoint(s) modified 2026-07-30
notable Trial sites expanded: 0 -> 3 locations 2026-07-30
Trial Details
NCT Number NCT07524140
Lead Sponsor Eilean Therapeutics
Conditions Advanced Solid Tumor Cancer, Metastatic Solid Tumor
Enrollment 60 participants
Start Date 2026-06-25
Primary Completion 2028-01 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-29