Advanced Solid TumorsPhase 1NCT05537740
A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors
A Phase 1 study testing BAY3375968 and Pembrolizumab in people with Advanced Solid Tumors, run by Bayer at 26 sites in 8 countries.
Trial summary
Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are solid cancers that may have spread to nearby tissue, lymph nodes and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments. 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?
- BAY3375968 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 26 sitesin 8 countries
- Study dates
- 11 Oct 2022to 4 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Capable of giving signed informed consent.
- Has received, been intolerant to, or been ineligible for all treatment options proven to confer clinical benefit.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.
- Adequate renal and liver function.
- Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.
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- Female participants are eligible if they are not pregnant, not breastfeeding or not a Woman of childbearing potential (WOCBP).
- Inclusion criterion for the dose-escalation: Individuals with histologically or cytologically confirmed, advanced or metastatic solid tumors.
- Inclusion criteria for disease-specific combination expansion: Individuals with histologically or cytologically confirmed triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), gastric cancer, melanoma, or head and neck squamous cell carcinoma (HNSCC).
- Inclusion criterion for the monotherapy-MoA expansion: Individuals with histologically or cytologically confirmed NSCLC, TNBC, HNSCC, or melanoma.
- Willingness and medical feasibility (as per Investigator assessment) to undergo paired tumor biopsies with a non-significant risk.
Who cannot join
- A known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Primary central nervous system malignancy.
- Major surgery ≤ 28 days before start of study treatment.
- Any unresolved toxicity of Grade ≥ 2, not otherwise specified in other eligibility criteria, from previous anticancer treatment, except for alopecia and skin pigmentation.
- Uncontrolled intercurrent illness requiring systemic treatment or solid organ transplant.
- Known hypersensitivity to study treatment or any drugs similar in structure or class, including severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
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- Any prior immune-related toxicity (Grade 3 or 4) leading to discontinuation of immunotherapy.
- History of congestive heart failure New York Heart Association (NYHA) >II.
- Medical history of (non-infectious) pneumonitis/interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically-active pneumonitis/ILD.
- HIV-infection with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
- Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the Investigator affect compliance with study requirements.
- New brain metastases on screening brain MRI/CT; previously treated brain metastases that are progressive at screening or leptomeningeal disease.
- Prior therapy with a C-C motif chemokine receptor 8 (CCR8) depleting antibody.
- Prior allogeneic tissue/solid organ transplant.
- Radiation therapy to the lung that is > 30 Gy within 6 months before the start of study treatment.
- Diagnosis of immunodeficiency or current chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent).
- Active autoimmune disease that has required systemic treatment in the past 2 years.
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
United States4 sites
UNC Hospitals - UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
Chicago, Illinois, 60637
START | San Antonio
San Antonio, Texas, 78229
South Texas Accelerated Research Therapeutics | START Rocky Mountain Region
West Valley City, Utah, 84119
Belgium4 sites
Antwerp University Hospital | Oncology Department
Antwerp, Antwerp, 2650
Ghent University Hospital | Drug Research Unit Department
Ghent, East Flanders, 9000
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - General Medical Oncology
Leuven, Flemish Brabant, 3000
CHU de Liège
Liège, 4000
China4 sites
Jilin Cancer Hospital
Changchun, Jilin, 130000
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
LinYi Cancer Hospital (Linyi Tumor Hospital)
Linyi, Shandong, 276001
France4 sites
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, New Aquitaine, 33000
Centre Oscar Lambret - Service Oncologie
Lille, Hauts-de-France, 59000
Institut de Cancerologie Ouest - Saint Herblain - Oncologie medicale
Saint-Herblain, Pays de la Loire Region, 44800
Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
Villejuif, Île-de-France Region, 94805
Spain4 sites
Hospital Universitari Vall D Hebron | Oncologia Medica
Barcelona, 08035
Clinica Universidad De Navarra | Madrid | Oncologia
Madrid, 28027
Hospital Universitario Hm Sanchinarro | Oncologia Medica
Madrid, 28050
Clinica Universidad De Navarra | Pamplona | Oncologia
Pamplona, Navarre, 31008
Singapore3 sites
National University Hospital Medical Centre
Singapore, 119074
National Cancer Center Singapore - Oncology Department
Singapore, 168583
OncoCare Cancer Centre | Gleneagles Medical Centre
Singapore, 258499
United Kingdom2 sites
The Christie NHS Foundation Trust - Christie Hospital
Manchester, Greater Manchester, M204BX
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, SM2 5PT
Canada1 site
Princess Margaret Cancer Centre - Oncology Department
Toronto, Ontario, M5G 2C4
About this study
Official title: First-in-human Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected Advanced Solid Tumors
Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are solid cancers that may have spread to nearby tissue, lymph nodes and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments.
A new therapy available for advanced solid cancers is immunotherapy with PD-1/PD-L1 inhibitors. This drug class stimulates immune cells to kill cancer cells by blocking a protein called PD-1. Although PD-1/PD-L1 inhibitors have shown benefits in treatment of cancer, only a subset of patients benefit from the initial therapy, while in others the cancer comes back. One reason could be that the ability of the patients' immune systems to kill cancer cells is weakened by so-called regulatory T cells which have a suppressive effect on the immune system.
Read more
The study treatment BAY3375968 is an antibody that binds to a protein called CCR8 which is located on the surface of regulatory T cells. This leads to a reduction in regulatory T cells and further inhibits their immune suppressive activity, so that the immune response against cancer can be strengthened as observed in animal models. Animal studies also showed that BAY3375968 may add more anti-cancer effect to immunotherapy with PD-1/PD-L1 inhibitors when used in combination. All of these previous observations need to be confirmed in humans.
The main aims of this study are to find for BAY3375968 alone and in combination with pembrolizumab (a PD-1 inhibitor):
- how safe it is
- the degree to which overt medical problems caused by the treatment(s) can be tolerated
- the highest amount of BAY3375968 that can be given alone or in combination with pembrolizumab.
- how it moves into, through, and out of the body.
To do this, researchers will collect and analyze data about:
- the number and severity of participants' medical problems after taking their treatments
- the best dose of BAY3375968 that can be given
- the highest level in the blood (Cmax) and the total level (AUC) of BAY3375968.
Doctors keep track of all medical problems (also called adverse events) that participants have during the study, even if they do not think that they might be related to the study treatment.
The researchers will also study the activity of BAY3375968 alone and in combination with pembrolizumab against the cancer.
The study will have 2 parts. Part 1 (dose escalation) focuses on tumor types that respond to immunotherapy. It will help to find the best dose for BAY3375968 alone and in combination with pembrolizumab that can be given in part 2. For this, the participants will receive one specific dose of several increasing BAY3375968 doses tested in part 1. Dose escalation of BAY3375968 alone will be done prior to the dose escalation of the combination with a fixed dose of pembrolizumab.
The participants of part 2 (dose expansion), will receive the best dose of BAY3375968 alone or in combination with pembrolizumab found in part 1. This part of the study focuses on certain cancer types of the lung, breast, head and neck cancer, gastric cancer and melanoma.
The total duration of the study will be approximately 4 years and 7 months. Each participant in the study will visit the study site twice before starting their treatment. Once the treatment starts, the frequency of visits is 5 times per week in the first treatment week and 1 to 3 times per month in later treatment periods. Another visit will be scheduled for the participants within 30 days after the last treatment in the study.
During the study, the study team will:
- take blood and urine samples
- do physical and vital signs examinations
- examine heart health using ECG and Echocardiogram
- check the tumor status and if the participants' cancer has grown and/or spread using imaging techniques
- take tumor samples
- ask questions about the impact of the disease on the participants' general well-being and activities of daily life.
About 90 days after the participants receive their last treatment and discontinued the study, the doctors will check the participants' health. In case a new anticancer therapy has been started, medical problems will be recorded via a phone call.
The study team will continue to check the participants' cancer status about every 12 weeks until their cancer gets worse, the start of a new anti-cancer therapy, or withdrawal of consent. In addition, every 6 months for up to 24 months after the last participant left the study the study team will check the participants' survival and subsequent anticancer treatment by phone until the end of this study.
- Conditions
- Advanced Solid Tumors
- Being tested
- BAY3375968, Pembrolizumab
- Keywords
- Relapse, Immunooncology treatment, Non small cell lung cancer, NSCLC, HNSCC, Head and neck squamous cell carcinomas, Melanoma, TNBC, Triple negative breast cancer
- Medical subject headings
- Recurrence, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Melanoma, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY3375968Drug
Also called Lanerkitug (INN)
Intravenous (IV) infusion
PembrolizumabDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation - Arm 1A | Experimental | Dose escalation of BAY3375968 as monotherapy Receives: Drug: BAY3375968 |
| Dose escalation - Arm 1B | Experimental | Dose escalation of BAY 3375968 in combination with pembrolizumab Receives: Drug: BAY3375968; Drug: Pembrolizumab |
| Dose expansion - Arm 2A | Experimental | BAY3375968 monotherapy-mode-of-action (monotherapy-MoA) expansion in subjects with one of the following tumor types: NSCLC, TNBC, HNSCC, or melanoma. The tumors should have primary (ICI-refractory) or secondary (ICI-relapsed) resistance to prior ICI-therapy. The final decision on the enrolled tumor type is at the discretion of the Sponsor. Receives: Drug: BAY3375968 |
| Dose expansion - Arm 2B | Experimental | Disease-specific combination expansion with separate cohorts in ICI-relapsed tumor types (NSCLC, TNBC, HNSCC, gastric cancer, or melanoma) Receives: Drug: BAY3375968; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) categorized by severity
Measured: First administration of study treatment up to 90 days after the last dose of study treatment
Maximum tolerated dose (MTD) or Maximum administered dose (MAD)
Measured: Up to 21 days
Number of participants experiencing dose-limiting toxicity (DLTs) at each dose level in the dose-escalation part of the study
Measured: Up to 21 days
Recommended dose for expansion (RDE)
Measured: Approximately 34 months
Peak plasma concentration after drug administration (Cmax) of BAY3375968
Measured: Up to 21 days after first drug administration
Area under the concentration-time curve (AUC) of BAY3375968
Measured: Up to 21 days after first drug administration
Secondary outcomes (4)
Objective response rate (ORR)
ORR (RECIST [Response Evaluation Criteria in Solid Tumors]) is defined as the proportion of participants with best overall response rating over the whole duration of the study of CR (complete response) or PR (partial response) according to RECIST 1.1 by Investigator assessment.
Measured: From start of treatment up to end of safety follow-up (90 days (±7 days) after the last administration of study treatment)
Fold change in serum IFN (Interferon)-γ in on-treatment compared with baseline serum samples
Measured: Approximately 60 months
Fold change in intratumor CD8+ T cell/Treg ratio in on-treatment compared with baseline tumor biopsies
Measured: Approximately 60 months
Recommended Phase 2 dose (RP2D)
Measured: Approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start11 Oct 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion4 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537740
- Sponsor's protocol ID
- 21820
- Status last verified
- Jul 2026
- First submitted
- 9 Sep 2022
- Last updated
- 7 Jul 2026
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Publications
Roider HG, Hoff S, Tseng SY, Berndt S, Trautwein M, Filarsky K, Gritzan U, Camps J, Nadler WM, Grudzinska-Goebel J, Ellinger P, Pesch T, Soon CF, Geyer M, Gluske K, Stelte-Ludwig B, Gorjanacz M. Selective depletion of tumor-infiltrating regulatory T cells with BAY 3375968, a novel Fc-optimized anti-CCR8 antibody. Clin Exp Med. 2024 Jun 10;24(1):122. doi: 10.1007/s10238-024-01362-8.
PubMed 38856863
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05537740
- Acronym / sponsor ID
- 21820
- Conditions
- Advanced Solid Tumors
- Keywords
- Relapse, Immunooncology treatment, Non small cell lung cancer, NSCLC, HNSCC, Head and neck squamous cell carcinomas, Melanoma, TNBC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 129 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 4 May 2027 (estimated)
- First posted
- 13 Sep 2022 (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 people who have advanced solid tumors. Advanced solid tumors are solid cancers that may have spread to nearby tissue, lymph nodes and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments.
A new therapy available for advanced solid cancers is immunotherapy with PD-1/PD-L1 inhibitors. This drug class stimulates immune cells to kill cancer cells by blocking a protein called PD-1. Although PD-1/PD-L1 inhibitors have shown benefits in treatment of cancer, only a subset of patients benefit from the initial therapy, while in others the cancer comes back. One reason could be that the ability of the patients' immune systems to kill cancer cells is weakened by so-called regulatory T cells which have a suppressive effect on the immune system.
The study treatment BAY3375968 is an antibody that binds to a protein called CCR8 which is located on the surface of regulatory T cells. This leads to a reduction in regulatory T cells and further inhibits their immune suppressive activity, so that the immune response against cancer can be strengthened as observed in animal models. Animal studies also showed that BAY3375968 may add more anti-cancer effect to immunotherapy with PD-1/PD-L1 inhibitors when used in combination. All of these previous observations need to be confirmed in humans.
The main aims of this study are to find for BAY3375968 alone and in combination with pembrolizumab (a PD-1 inhibitor):
- how safe it is
- the degree to which overt medical problems caused by the treatment(s) can be tolerated
- the highest amount of BAY3375968 that can be given alone or in combination with pembrolizumab.
- how it moves into, through, and out of the body.
To do this, researchers will collect and analyze data about:
- the number and severity of participants' medical problems after taking their treatments
- the best dose of BAY3375968 that can be given
- the highest level in the blood (Cmax) and the total level (AUC) of BAY3375968.
Doctors keep track of all medical problems (also called adverse events) that participants have during the study, even if they do not think that they might be related to the study treatment.
The researchers will also study the activity of BAY3375968 alone and in combination with pembrolizumab against the cancer.
The study will have 2 parts. Part 1 (dose escalation) focuses on tumor types that respond to immunotherapy. It will help to find the best dose for BAY3375968 alone and in combination with pembrolizumab that can be given in part 2. For this, the participants will receive one specific dose of several increasing BAY3375968 doses tested in part 1. Dose escalation of BAY3375968 alone will be done prior to the dose escalation of the combination with a fixed dose of pembrolizumab.
The participants of part 2 (dose expansion), will receive the best dose of BAY3375968 alone or in combination with pembrolizumab found in part 1. This part of the study focuses on certain cancer types of the lung, breast, head and neck cancer, gastric cancer and melanoma.
The total duration of the study will be approximately 4 years and 7 months. Each participant in the study will visit the study site twice before starting their treatment. Once the treatment starts, the frequency of visits is 5 times per week in the first treatment week and 1 to 3 times per month in later treatment periods. Another visit will be scheduled for the participants within 30 days after the last treatment in the study.
During the study, the study team will:
- take blood and urine samples
- do physical and vital signs examinations
- examine heart health using ECG and Echocardiogram
- check the tumor status and if the participants' cancer has grown and/or spread using imaging techniques
- take tumor samples
- ask questions about the impact of the disease on the participants' general well-being and activities of daily life.
About 90 days after the participants receive their last treatment and discontinued the study, the doctors will check the participants' health. In case a new anticancer therapy has been started, medical problems will be recorded via a phone call.
The study team will continue to check the participants' cancer status about every 12 weeks until their cancer gets worse, the start of a new anti-cancer therapy, or withdrawal of consent. In addition, every 6 months for up to 24 months after the last participant left the study the study team will check the participants' survival and subsequent anticancer treatment by phone until the end of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose escalation - Arm 1A | Experimental | Drug: BAY3375968Dose escalation of BAY3375968 as monotherapy |
| Dose escalation - Arm 1B | Experimental | Drug: BAY3375968, Drug: PembrolizumabDose escalation of BAY 3375968 in combination with pembrolizumab |
| Dose expansion - Arm 2A | Experimental | Drug: BAY3375968BAY3375968 monotherapy-mode-of-action (monotherapy-MoA) expansion in subjects with one of the following tumor types: NSCLC, TNBC, HNSCC, or melanoma. The tumors should have primary (ICI-refractory) or secondary (ICI-relapsed) resistance to prior ICI-therapy. The final decision on the enrolled tumor type is at the discretion of the Sponsor. |
| Dose expansion - Arm 2B | Experimental | Drug: BAY3375968, Drug: PembrolizumabDisease-specific combination expansion with separate cohorts in ICI-relapsed tumor types (NSCLC, TNBC, HNSCC, gastric cancer, or melanoma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Capable of giving signed informed consent.
- Has received, been intolerant to, or been ineligible for all treatment options proven to confer clinical benefit.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.
- Adequate renal and liver function.
Key exclusion criteria (19 listed)
- A known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Primary central nervous system malignancy.
- Major surgery ≤ 28 days before start of study treatment.
- Any unresolved toxicity of Grade ≥ 2, not otherwise specified in other eligibility criteria, from previous anticancer treatment, except for alopecia and skin pigmentation.
- Uncontrolled intercurrent illness requiring systemic treatment or solid organ transplant.
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 |
|---|---|---|
| BAY3375968Also: Lanerkitug (INN)Intravenous (IV) infusion | Drug | Dose escalation - Arm 1A, Dose escalation - Arm 1B, Dose expansion - Arm 2A, Dose expansion - Arm 2B |
| PembrolizumabIV infusion | Drug | Dose escalation - Arm 1B, Dose expansion - Arm 2B |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) categorized by severity
Time frame: First administration of study treatment up to 90 days after the last dose of study treatment
Maximum tolerated dose (MTD) or Maximum administered dose (MAD)
Time frame: Up to 21 days
Number of participants experiencing dose-limiting toxicity (DLTs) at each dose level in the dose-escalation part of the study
Time frame: Up to 21 days
Recommended dose for expansion (RDE)
Time frame: Approximately 34 months
Peak plasma concentration after drug administration (Cmax) of BAY3375968
Time frame: Up to 21 days after first drug administration
Area under the concentration-time curve (AUC) of BAY3375968
Time frame: Up to 21 days after first drug administration
4 secondary outcomes
Objective response rate (ORR)
Time frame: From start of treatment up to end of safety follow-up (90 days (±7 days) after the last administration of study treatment)
Fold change in serum IFN (Interferon)-γ in on-treatment compared with baseline serum samples
Time frame: Approximately 60 months
Fold change in intratumor CD8+ T cell/Treg ratio in on-treatment compared with baseline tumor biopsies
Time frame: Approximately 60 months
Recommended Phase 2 dose (RP2D)
Time frame: Approximately 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 38856863Roider HG, Hoff S, Tseng SY, Berndt S, Trautwein M, Filarsky K, Gritzan U, Camps J, Nadler WM, Grudzinska-Goebel J, Ellinger P, Pesch T, Soon CF, Geyer M, Gluske K, Stelte-Ludwig B, Gorjanacz M. Selective depletion of tumor-infiltrating regulatory T cells with BAY 3375968, a novel Fc-optimized anti-CCR8 antibody. Clin Exp Med. 2024 Jun 10;24(1):122. doi: 10.1007/s10238-024-01362-8.
- 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.clinicalstudydatarequest.com 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 Study sponsors 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.
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY3375968 and Pembrolizumab in people with Advanced Solid Tumors, run by Bayer at 26 sites in 8 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 11 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Belgium, China, France, Spain and 3 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with treatment-emergent adverse events (TEAEs) categorized by severity (time frame: First administration of study treatment up to 90 days after the last dose of study treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05537740, which also lists 1 linked publication.
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 7 Jul 2026.