NCT07524140

Study of ZE94-0605 in Patients With Advanced Solid Tumors, With Dose Expansion Cohorts.

Phase 1 Study of ZE94-0605 in Solid Tumors Who Have Exhausted All Treatment Options and Then With Expansion Into Two Dose Cohorts in Select Solid Tumor Patients

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Eilean Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 Study of ZE94-0605 in solid tumors who have exhausted all treatment options and then with expansion into two dose cohorts in select solid tumor patients.

Detailed description

This phase 1 study will focus on dose escalation across all solid tumor patients who have no alternative therapies to determine the maximally tolerated dose (MTD) followed by a two dose level expansion (MTD and one dose below) in solid tumors who have amplified CCNE1 (or other molecular/cellular feature determined at a later time) to fulfill the guidelines set forth by project Optimus.

Conditions

• Solid Tumor Malignancies
• Solid Cancer
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	ZE94-0605	Oral capsules QD

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-01-01
• Completion: 2028-05-01
• First posted: 2026-04-13
• Last updated: 2026-04-13