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NCT05614102 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Advanced Solid Tumors, sponsored by Bayer.
- Active
- Registry status
- Phase 1
- Development phase
- 284
- Enrollment target
- 20
- Study locations
NCT05614102: Active Phase 1 study of Advanced Solid Tumors, sponsored by Bayer.
NCT05614102 is a Phase 1 study of Advanced Solid Tumors that is active but no longer recruiting, run by Bayer. The registered enrollment target is 284 participants, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05614102, a Phase 1 study of Advanced Solid Tumors, is active but no longer recruiting, sponsored by Bayer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 284 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT05614102 still lists
NCT05614102 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (44% higher).
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.
NCT05614102 names 20 study sites across 12 states, led by Other, Colorado, Pennsylvania.
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.
What interventions are being tested in trial NCT05614102?
The interventions under investigation include: Pembrolizumab (DRUG), BAY2965501 (DRUG), Platinum-based Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT05614102?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05614102's enrollment target sits among peer trials
284 31st of 144 higher than 114 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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