Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT04999202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-08-05
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
An Open-label Phase 1b Dose Escalation and Expansion Study to Evaluate the Safety Tolerability Maximum Tolerated or Administered Dose Pharmacokinetics Pharmacodynamics and Efficacy of the Aryl Hydrocarbon Receptor Inhibitor AhRi BAY 2416964 in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 participants can take the study treatment until their cancer gets worse until they have medical problems or until they leave the trial Participants will have around 4 visits in each cycle Some of the visits can also be done via phone
During the study the study doctors and their team will
take blood and urine samples
check if the participants cancer has changed in size using computed tomography scans or magnetic resonance imaging scans of the participants tumors
check the participants overall health
ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study Doctors keep track of all adverse events that happen in studies even if they do not think the adverse events might be related to the study treatments
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 participants can take the study treatment until their cancer gets worse until they have medical problems or until they leave the trial Participants will have around 4 visits in each cycle Some of the visits can also be done via phone
During the study the study doctors and their team will
take blood and urine samples
check if the participants cancer has changed in size using computed tomography scans or magnetic resonance imaging scans of the participants tumors
check the participants overall health
ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study Doctors keep track of all adverse events that happen in studies even if they do not think the adverse events might be related to the study treatments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PN-A61 | OTHER | None | None |
| 2023-503547-33-00 | OTHER | None | None |
| 2020-003547-28 | EUDRACT_NUMBER | CTIS EU | None |