stop_circleTerminated/Withdrawn
Advanced solid tumors
Bayer Identifier:
21343
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
47Trial Dates
August 2021 - January 2025Phase
Phase 1Could I Receive a placebo
NoProducts
BAY2416964Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit | Detroit, 48202, United States |
Withdrawn | Baptist Health South Florida Miami Cancer Institute | Miami, 33176, United States |
Completed | Sarah Cannon Research Institute | Nashville, 37203, United States |
Active, not recruiting | Texas Oncology- Austin Midtown | Austin, 78705, United States |
Active, not recruiting | Freeman Hospital | Newcastle, NE7 7DN, United Kingdom |
Withdrawn | Clatterbridge Centre for Oncology | Bebington, CH63 4JY, United Kingdom |
Withdrawn | Southampton General Hospital | Southampton, SO16 6YD, United Kingdom |
Active, not recruiting | National University Hospital Medical Centre | Singapore, 119074, Singapore |
Withdrawn | National Cancer Center Singapore | Singapore, 168583, Singapore |
Active, not recruiting | Belfast City Hospital | Belfast, BT12 7AB, United Kingdom |
Active, not recruiting | Florida Cancer Specialists & Research Institute | Sarasota, 34232, United States |
Completed | ASST Grande Ospedale Metropolitano Niguarda | Milano, 20162, Italy |
Completed | Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia | Rozzano, 20089, Italy |
Completed | Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative | Milano, 20141, Italy |
Active, not recruiting | Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1 | Milano, 20133, Italy |
Active, not recruiting | IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Sperimentazioni Cliniche | Napoli, 80131, Italy |
Completed | Virginia Cancer Specialists, PC | Fairfax, 22031, United States |
Completed | Florida Cancer Specialists | Altamonte Springs, 32701, United States |
Withdrawn | University College London Hospitals NHS Foundation Trust | London, NW1 2BU, United Kingdom |
Primary Outcome
- The incidence of TEAEs including TESAEsTEAEs: treatment-emergent adverse events TESAEs: treatment-emergent serious adverse eventsdate_rangeTime Frame:After first administration of BAY2416964 in combination with pembrolizumab up to 90 days after the last dose of BAY2416964 in combination with pembrolizumab
- The severity of TEAEs including TESAEsdate_rangeTime Frame:After first administration of BAY2416964 in combination with pembrolizumab up to 90 days after the last dose of BAY2416964 in combination with pembrolizumab
- Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2416964The MTD/MAD is the dose level that can be safely given, defined as the occurrence of dose-limiting toxicities (DLTs) below a certain threshold.date_rangeTime Frame:Cycle 1 (21 days) in dose escalation
Secondary Outcome
- Cmax of BAY2416964 after single-dose in Cycle 1date_rangeTime Frame:Cycle 1 Day 1 (1 cycle is 21 days)
- Cmax of BAY2416964 after multiple-dose in Cycle 1date_rangeTime Frame:Cycle 1 Day 15 (1 cycle is 21 days)
- AUC(0-t) (t depend on the dosing regimen) of BAY2416964 after single-dose in Cycle 1date_rangeTime Frame:Cycle 1 Day 1 (1 cycle is 21 days)
- AUC(0-t) (t depend on the dosing regimen) of BAY2416964 after multiple-dose in Cycle 1date_rangeTime Frame:Cycle 1 Day 15 (1 cycle is 21 days)
- Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)ORR will be evaluated using RECIST 1.1 by investigator assessment.date_rangeTime Frame:At the end of Cycle 2 (-7 days, each cycle is 21 days), Cycle 4 (-7 days) and at the end of every third cycle (-7 days) from Cycle 5 onwards
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
2