RecruitingPhase 1NCT07524140

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

A Phase 1, First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors

Sponsor

Eilean Therapeutics

Enrollment

60 participants

Start Date

Jun 25, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic Solid Tumor Advanced Solid Tumor Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ZE94-0605 for people with advanced solid tumor cancer and metastatic solid tumor. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZE94-0605

Oral capsules QD

Locations(3)

St. George Private hospital

Kogarah, New South Wales, Australia

SOCRU - Southern Oncology Clinical Research Unit

Bedford Park, South Australia, Australia

Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology Uzbekistan

Tashkent, Uzbekistan

View Full Details on ClinicalTrials.gov

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NCT07524140

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