NCT03188965

First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas

An Open-label, First-in-human, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose and / or Recommended Phase II Dose of the ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ATR (ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for the treatment of patients with advanced solid tumors and lymphomas. The purpose of the proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further, the response of the cancer to the treatment will be determined.

Conditions

• Advanced Solid Tumor
• Non-Hodgkin's Lymphoma
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Elimusertib (BAY1895344)	Solution or tablet, oral, to be administered until evidence of tumor progression, unacceptable toxicity, consent withdrawal, or withdrawal from the study at the discretion of the investigator.

Timeline

• Start date: 2017-07-06
• Primary completion: 2022-12-02
• Completion: 2023-09-13
• First posted: 2017-06-16
• Last updated: 2023-10-11

Locations

29 sites across 7 countries: United States, Canada, China, Japan, Singapore, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study