NCT06253130

A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Eikon Therapeutics · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.

Detailed description

This study will evaluate the safety, tolerability and preliminary efficacy of IMP1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. This study includes 2 parts: Part 1 and Part 2. Part 1 includes a monotherapy dose escalation of EIK1003 followed by combination dose escalations in metastatic prostate cancer (mPC), ovarian and breast cancer. Part 1, dose escalation, the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor. Part 2 will explore dose optimization with selection of an optimal dose for future clinical development of EIK1003.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	IMP1734	PARP1 selective inhibitor

Timeline

• Start date: 2023-12-11
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2024-02-12
• Last updated: 2026-03-23

Locations

53 sites across 8 countries: United States, Australia, Canada, China, Denmark, France, South Korea, Spain

Regulatory

• FDA-regulated drug study