NCT06232408

LIONS (PLK4 Inhibitor in Advanced Solid Tumors)

Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-1664 in Participants With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Repare Therapeutics · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to identify a safe and tolerated dose and schedule of the orally administered PLK4 inhibitor RP-1664. In addition, this study will examine the pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RP-1664 in advanced solid tumors.

Detailed description

This is a first-in-human, Phase 1, multi-center, open-label, dose-escalation and expansion study to: Evaluate the safety profile and MTD of RP-1664 and establish a recommended dose and schedule for further clinical investigation, In addition, the study aims to characterize the PK, PD, and preliminary anti-tumor activity of orally administered RP-1664. Exploratory objectives include examination of biomarker responses in relationship to RP-1664 exposure. After the recommended dose and schedule is determined, expansion cohorts with molecularly selected advanced solid tumors will be enrolled to preliminarily assess the anti-tumor effect, and further examine the safety and PK of RP-1664 at the RP2D.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	RP-1664	RP-1664 will be supplied as immediate-release solid dosage form for oral self-administration.

Timeline

• Start date: 2024-02-14
• Primary completion: 2025-08-27
• Completion: 2025-08-27
• First posted: 2024-01-30
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

5 sites across 2 countries: United States, Denmark

Regulatory

• FDA-regulated drug study