Advanced Solid TumorsPhase 1NCT04999202
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 testing BAY2416964 and Pembrolizumab in people with Advanced Solid Tumors, run by Bayer at 14 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BAY2416964 and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 30 Aug 2021to 20 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
- Participants with following histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease that are known to confer clinically meaningful benefit, or are intolerant to treatment, or refuse standard treatment.
- Dose Escalation: all solid tumor types
- Tumor type-specific Expansion cohorts:
- NSCLC
- HNSCC with primary location in oropharynx, oral cavity, hypopharynx or larynx
Show all 10Show fewer
- Urothelial Cancer
- Participants must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.
- Have measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Who cannot join
- Severe (Common terminology criteria for adverse events (CTCAE) v.5 Grade ≥ 3) infections within 4 weeks before the first study intervention administration
- Active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy
- Has active Central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Cardiac disease as specified in the protocol
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States6 sites
Florida Cancer Specialists
Altamonte Springs, Florida, 32701
Texas Oncology- Austin Midtown
Austin, Texas, 78705
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, 48202
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Florida Cancer Specialists & Research Institute
Sarasota, Florida, 34232
Italy5 sites
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, Lombardy, 20133
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
Milan, Lombardy, 20141
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Sperimentazioni Cliniche
Naples, Campania, 80131
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, Lombardy, 20089
United Kingdom2 sites
Belfast City Hospital
Belfast, North Ireland, BT12 7AB
Freeman Hospital
Newcastle, Tyne and Wear, NE7 7DN
Singapore1 site
National University Hospital Medical Centre
Singapore, 119074
About this study
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
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.
Read more
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- BAY2416964, Pembrolizumab
- Keywords
- Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Urothelial Cancer, Advanced cancer, Immunotherapy, Immuno oncology, Aryl Hydrocarbon Receptor inhibitor(AhRi), Aryl Hydrocarbon Receptor, Pembrolizumab, aPD1, Checkpoint inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2416964Drug
Oral, twice or three times daily
BAY2416964Drug
The highest dose determined safe in combination with pembrolizumab in the dose escalation part or a lower dose. More than one dose may be explored in the dose expansion.
PembrolizumabDrug
Administered as a dose of 200 mg using a 30-minute IV infusion every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation of BAY2416964 | Experimental | Six dose levels of BAY 2416964 (as determined in the first in human mono-therapy study of BAY2416964) are planned in combination with standard dose Pembrolizumab. Receives: Drug: BAY2416964; Drug: Pembrolizumab |
| Dose expansion of BAY2416964 in tumor type specific cohort | Experimental | To determine the RP2D of BAY2416964 in combination therapy with pembrolizumab. Participants will be enrolled in up to 3 tumor type-specific cohorts including relapsed/refractory non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and urothelial cancer. Receives: Drug: BAY2416964; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of TEAEs including TESAEs
TEAEs: treatment-emergent adverse events TESAEs: treatment-emergent serious adverse events
Measured: 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 TESAEs
Measured: 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 BAY2416964
The MTD/MAD is the dose level that can be safely given, defined as the occurrence of dose-limiting toxicities (DLTs) below a certain threshold.
Measured: Cycle 1 (21 days) in dose escalation
Secondary outcomes (5)
Cmax of BAY2416964 after single-dose in Cycle 1
Measured: Cycle 1 Day 1 (1 cycle is 21 days)
Cmax of BAY2416964 after multiple-dose in Cycle 1
Measured: 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 1
Measured: 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 1
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start30 Aug 2021
- Primary completion28 Jun 2024
- Study completion20 Jan 2025
Why it stopped: Last patient ongoing on treatment ended the study on 20th January 2025. Hence, the end of study was reached as defined in the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999202
- Sponsor's protocol ID
- 21343
- Other IDs
- PN-A61, 2023-503547-33-00, 2020-003547-28, 2023
- Status last verified
- Feb 2025
- First submitted
- 5 Aug 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04999202
- Acronym / sponsor ID
- 21343
- Conditions
- Advanced Solid Tumors
- Keywords
- Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Urothelial Cancer, Advanced cancer, Immunotherapy, Immuno oncology, Aryl Hydrocarbon Receptor inhibitor(AhRi), Aryl Hydrocarbon Receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Last patient ongoing on treatment ended the study on 20th January 2025. Hence, the end of study was reached as defined in the protocol.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation of BAY2416964 | Experimental | Drug: BAY2416964, Drug: PembrolizumabSix dose levels of BAY 2416964 (as determined in the first in human mono-therapy study of BAY2416964) are planned in combination with standard dose Pembrolizumab. |
| Dose expansion of BAY2416964 in tumor type specific cohort | Experimental | Drug: BAY2416964, Drug: PembrolizumabTo determine the RP2D of BAY2416964 in combination therapy with pembrolizumab. Participants will be enrolled in up to 3 tumor type-specific cohorts including relapsed/refractory non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and urothelial cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
- Participants with following histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease that are known to confer clinically meaningful benefit, or are intolerant to treatment, or refuse standard treatment.
- Participants must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.
- Have measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Key exclusion criteria (6 listed)
- Severe (Common terminology criteria for adverse events (CTCAE) v.5 Grade ≥ 3) infections within 4 weeks before the first study intervention administration
- Active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy
- Has active Central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY2416964Oral, twice or three times daily | Drug | Dose escalation of BAY2416964 |
| BAY2416964The highest dose determined safe in combination with pembrolizumab in the dose escalation part or a lower dose. More than one dose may be explored in the dose expansion. | Drug | Dose expansion of BAY2416964 in tumor type specific cohort |
| PembrolizumabAdministered as a dose of 200 mg using a 30-minute IV infusion every 3 weeks | Drug | Dose escalation of BAY2416964, Dose expansion of BAY2416964 in tumor type specific cohort |
Primary outcome
The incidence of TEAEs including TESAEs
Time frame: After first administration of BAY2416964 in combination with pembrolizumab up to 90 days after the last dose of BAY2416964 in combination with pembrolizumab
TEAEs: treatment-emergent adverse events TESAEs: treatment-emergent serious adverse events
The severity of TEAEs including TESAEs
Time 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 BAY2416964
Time frame: Cycle 1 (21 days) in dose escalation
The MTD/MAD is the dose level that can be safely given, defined as the occurrence of dose-limiting toxicities (DLTs) below a certain threshold.
5 secondary outcomes
Cmax of BAY2416964 after single-dose in Cycle 1
Time frame: Cycle 1 Day 1 (1 cycle is 21 days)
Cmax of BAY2416964 after multiple-dose in Cycle 1
Time 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 1
Time 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 1
Time 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)
Time 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
Results and safety
The study was stopped early (reason given: Last patient ongoing on treatment ended the study on 20th January 2025. Hence, the end of study was reached as defined in the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2416964 and Pembrolizumab in people with Advanced Solid Tumors, run by Bayer at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Italy, United Kingdom, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Last patient ongoing on treatment ended the study on 20th January 2025. Hence, the end of study was reached as defined in the protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of TEAEs including TESAEs (time 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.