NCT04095273

Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug

A Multicenter, Non-randomized, Open-label Phase 1b Study to Determine the Maximum Tolerated and Recommended Phase 2 Dose of the ATR Inhibitor Elimusertib in Combination With Pembrolizumab and to Characterize Its Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Participants With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to test how well patients with advanced solid tumors respond to treatment with elimusertib (BAY1895344) in combination with pembrolizumab. In addition researchers want to find for patients the optimal dose of elimusertib in combination with pembrolizumab, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication, elimusertib, works by blocking a substance (ATR Kinase) which is produced by the body and is important for the growth of tumor cells. Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against the tumor.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Elimusertib (BAY1895344)	Study drugs will be administered as scheduled
DRUG	Pembrolizumab (Keytruda®)	Study drugs will be administered as scheduled

Timeline

• Start date: 2019-09-30
• Primary completion: 2022-11-24
• Completion: 2023-04-11
• First posted: 2019-09-19
• Last updated: 2024-04-02

Locations

16 sites across 5 countries: United States, Germany, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study