NCT05269316

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation and Dose-expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of the ATR Inhibitor IMP9064 Monotherapy and in Combination With PARP Inhibitor Senaparib in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Impact Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of IMP9064 as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors

Detailed description

IMP9064 is an investigational therapeutic protein that may prevent repair of DNA damage in tumor cell. IMP9064 acts as inhibitor (blocker)of the proteins ataxia-telangiectasia and Rad3-related kinase (ATR) which are important in cancer cell DNA repair. If cancer cells cannot repair damage to their DNA, then there is a high possibility that cancer cells will not survive.

Conditions

• Solid Tumor
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	IMP9064	IMP9064 Monotherapy administered for 21 days

Timeline

• Start date: 2022-02-11
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-03-07
• Last updated: 2025-04-01

Locations

8 sites across 4 countries: United States, Australia, China, Taiwan

Regulatory

• FDA-regulated drug study