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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
NCT05537740 · View on ClinicalTrials.gov ↗
Study 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. 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 i
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG BAY3375968
Study Locations (20)
Other
- Antwerp University Hospital | Oncology Department — Antwerp
- Ghent University Hospital | Drug Research Unit Department — Ghent
- Universitair Ziekenhuis Leuven | Gasthuisberg Campus - General Medical Oncology — Leuven
- CHU de Liège — Liège
- LinYi Cancer Hospital (Linyi Tumor Hospital) — Linyi
- National University Hospital Medical Centre — Singapore
- National Cancer Center Singapore - Oncology Department — Singapore
- OncoCare Cancer Centre | Gleneagles Medical Centre — Singapore
Guangdong
- Guangdong Provincial People's Hospital — Guangzhou
- The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou
Illinois
- The University of Chicago Medical Center - Hyde Park - Hematology & Oncology — Chicago
North Carolina
- UNC Hospitals - UNC Lineberger Comprehensive Cancer Center — Chapel Hill
Texas
- START | San Antonio — San Antonio
Utah
- South Texas Accelerated Research Therapeutics | START Rocky Mountain Region — West Valley City
Ontario
- Princess Margaret Cancer Centre - Oncology Department — Toronto
Jilin
- Jilin Cancer Hospital — Changchun
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2022-10-11 |
| Est. Completion | 2027-05-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05537740
The ClinicalTrials.gov registry entry for NCT05537740 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05537740 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Guangdong, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05537740 about?
NCT05537740 is a clinical study titled "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". 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....
What is the current status of trial NCT05537740?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 129 participants. The study started on 2022-10-11. Estimated completion is 2027-05-04.
What conditions does trial NCT05537740 study?
This clinical trial studies the following conditions: Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05537740?
The interventions under investigation include: Pembrolizumab (DRUG), BAY3375968 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05537740?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05537740 being conducted?
This trial has 20 study locations across Illinois, North Carolina, Texas, Utah, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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