Phase 1 Study of Oral ZE94-0605 for Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating ZE94-0605, an oral selective cyclin-dependent kinase 2 CDK2 inhibitor, in adults with advanced, unresectable, or metastatic solid tumors that have not responded to or are intolerant of existing therapies. This first-in-human, open-label Phase 1 study consists of two parts Phase 1a to find the highest safe dose and biologically effective dose through sequential dose escalation, and Phase 1b to randomize participants with specific molecular features such as CCNE1 amplification to determine the recommended Phase 2 dose. ZE94-0605 is given orally once daily in a fasted state in continuous 28-day cycles. Phase 1a explores doses from 50 mg optional up to 650 mg or higher if needed, while Phase 1b randomizes about 30 participants to receive either the maximum tolerated dose or one dose level below it. Treatment continues until disease progression, unacceptable side effects, withdrawal, or completion of 26 cycles. Participants will undergo regular assessments including response evaluations before dosing on several cycle days, detailed pharmacokinetic and biomarker testing during early cycles, and circulating tumor DNA analysis at multiple timepoints. Researchers will monitor safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity. The study duration may extend up to approximately 24 months with ongoing monitoring and follow-up.

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