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NCT04999202 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT04999202 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 47 participants.
The verdict
NCT04999202, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to treat advanced solid cancers including head and neck cancer, lung cancer and bladder cancer. In some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent immune cells from fighting tumor cells. The study drug, BAY 2416964, is a small molecule which blocks the AhR allowing the body to use its immune response against the cancer cells. Researchers think that BAY 2416964 given together with a cancer treatment called pembrolizumab may help shrink tumors in people with cancer. The main aims of this study are to find for BAY 2416964 in combination with pembrolizumab, * how safe this drug combination is * how it affects the body (also referred to as tolerability) * the highest amount of BAY 2416964 that can be given in combination with pembrolizumab without too many side effects. The researchers will also study the action of BAY 2416964 in combination with pembrolizumab against the cancer. The participants in this study will get BAY 2416964 and pembrolizumab. BAY 2416964 will be given by mouth. Pembrolizumab will be given as an intravenous (IV) infusion. An IV infusion is given through a needle into a vein. This study will have two parts. The first part will help find the most appropriate dose that can be given in the second part. Each participant of the first, so called dose escalation part, will be assigned to one specific dose group for BAY 2416964. The amount of BAY 2416964 that is given changes step-wise from one group to the next. The dose of pembrolizumab will always be the same. The participants of the second, so called dose expansion part, will receive the most appropriate dose of BAY 2416964 found in the first part. During the study, the participants will receive the treatment in 3-week periods called cycles. In each cycle, the participants will in general get pembrolizumab once and BAY 2416964 in a daily schedule. These 3-week cycles will be repeated throughout the trial. The particip
Interventions
- DRUG Pembrolizumab
- DRUG BAY2416964
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2025-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04999202
The ClinicalTrials.gov registry entry for NCT04999202 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04999202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04999202 about?
NCT04999202 is a clinical study titled "A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults". Researchers are looking for a better way to treat advanced solid cancers including head and neck cancer, lung cancer and bladder cancer. In some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent immune cells from fighting tumor cells. The study drug, BAY 2416964, is a ...
What is the current status of trial NCT04999202?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2021-08-30. Estimated completion is 2025-01-20.
What interventions are being tested in trial NCT04999202?
The interventions under investigation include: Pembrolizumab (DRUG), BAY2416964 (DRUG).
Who is sponsoring clinical trial NCT04999202?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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