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NCT07524140
A First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors
Conditions: Advanced Solid Tumor Cancer, Metastatic Solid Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 60
Sponsor: Eilean Therapeutics
Location: St. George Private hospital Kogarah New South Wales
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 between two dose levels to select the recommended Phase 2 dose.
Eligibility Criteria
Inclusion Criteria
Phase 1a Dose-Escalation Cohorts:
1. Age ≥18 years, with a pathologically confirmed, advanced, unresectable or metastatic solid tumor refractory to, or intolerant of, available therapies known to provide clinical benefit for the participant's condition, if available, and with measurable disease.
Phase 1b Dose-Expansion Cohorts:
2. Age ≥18 years, with a pathologically confirmed, advanced, unresectable or metastatic solid tumor refractory to, or intolerant of, available therapies known to provide clinical benefit for the participant's condition, if available, or who has declined such therapy, with CCNE1 amplification and measurable disease.
Common Inclusion Criteria:
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
4. Adequate end-organ function: creatinine clearance \>60 mL/min; AST and ALT \
Source: ClinicalTrials.gov (NCT07524140). StuddyBuddy aggregates publicly available trial information.
