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NCT03188965 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 229
- Enrollment target
NCT03188965: Completed Phase 1 study, sponsored by Bayer.
NCT03188965 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 229 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (282% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03188965, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 229 participants
- Enrollment target
Study 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.
Primary Outcome
MTD and/or R2PD will be determined in Cycle 1 of Part A, Part A.1 and J-arm of Part A. The MTD is defined as the maximum dose at which the incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 30%, or the maximum dose tested, whichever is achieved first during dose-escalation.
Interventions
- DRUG Elimusertib (BAY1895344)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2023-09-13 |
| Phase | Phase 1 |
What the finished NCT03188965 record still lists
NCT03188965 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (282% higher).
The record links to 0 conditions, and to 1 intervention - of which Elimusertib (BAY1895344) is the first listed.
NCT03188965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03188965 about?
NCT03188965 is a clinical study titled "First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas". 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...
What is the current status of trial NCT03188965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 229 participants. The study started on 2017-07-06. Estimated completion is 2023-09-13.
What interventions are being tested in trial NCT03188965?
The interventions under investigation include: Elimusertib (BAY1895344) (DRUG).
Who is sponsoring clinical trial NCT03188965?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03188965's enrollment target sits among peer trials
229 221st of 2000 higher than 1,780 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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