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A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors
NCT05614102 · 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 types of cancer 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. This study focuses on certain types of skin cancer, kidney cancer, stomach cancer, and lung cancer. The study treatment BAY2965501 is currently under development as monotherapy or in combination for the treatment of people with advanced solid tumors. BAY2965501 blocks an enzyme in T-cells to activate them. T-cells are a type of immune cell that are known to have an anti-cancer effect and BAY2965501 is a potential new immunotherapy. The main purpose of this first-in-human study is to learn: • how safe different doses of BAY2965501 are when given as a single drug or in combination, • the degree to which medical problems caused by BAY2965501 when given as a single drug or in combination, can be tolerated (also called tolerability), • what maximum amount can be given as a single drug or in combination, and • how it moves into, through and out of the body as a single drug or in combination. To answer this, researchers will look at: • the number and severity of medical problems participants have after taking BAY2965501 as a single drug or in combination for each dose level. These medical problems are also referred to as adverse events. • the (average) total level of BAY2965501 in the blood (also called AUC) after intake of single and multiple doses • the (average) highest level of BAY2965501 in the blood (also called Cmax) after intake of single and multiple doses Doctors keep track of all medical problems that participants have during the study, even if they do not think the medical problem might be related to the study treatment. In addition, the researchers want to know if and how the participants' tumors change after taking BAY2965501. The study will have two parts. The
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG BAY2965501
- DRUG Platinum-based Chemotherapy
Study Locations (20)
Other
- Antwerp University Hospital | Oncology Department — Antwerp
- Ghent University Hospital | Drug Research Unit Department — Ghent
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen
- Samsung Medical Center - Oncology Department — Seoul
- Hospital Hm Nou Delfos | Oncologia — Barcelona
- Hospital Universitari Vall D Hebron | Oncologia — Barcelona
- Clinica Universidad De Navarra | Oncologia — Madrid
- Hospital Universitario Hm Sanchinarro | Oncologia — Madrid
Colorado
- Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's — Denver
Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh
Texas
- START | San Antonio — San Antonio
Zhejiang
- Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department — Hangzhou
Chiba
- National Cancer Center Hospital East — Kashiwa
Gyeonggido
- Seoul National University Bundang Hospital — Seongnam-si
Seoul Teugbyeolsi
- Severance Hospital, Yonsei University Health System - Oncology Department — Seoul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2022-11-04 |
| Est. Completion | 2027-09-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05614102
The ClinicalTrials.gov registry entry for NCT05614102 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 284 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 3 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: NCT05614102 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Colorado, Pennsylvania. 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 NCT05614102 about?
NCT05614102 is a clinical study titled "A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors 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 types of cancer 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 treatmen...
What is the current status of trial NCT05614102?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 284 participants. The study started on 2022-11-04. Estimated completion is 2027-09-09.
What conditions does trial NCT05614102 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 NCT05614102?
The interventions under investigation include: Pembrolizumab (DRUG), BAY2965501 (DRUG), Platinum-based Chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05614102?
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 NCT05614102 being conducted?
This trial has 20 study locations across Colorado, Pennsylvania, Texas, Zhejiang, Chiba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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