New cancer drug BAY2965501 enters first human tests
NCT ID NCT05614102
First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times
Summary
This early-stage trial tests a new drug called BAY2965501, which boosts the immune system to fight cancer. It is given alone or with other drugs like pembrolizumab and chemotherapy. The study includes about 284 people with advanced solid tumors (skin, kidney, stomach, or lung cancer) that have not responded to standard treatments. The main goals are to check safety, find the best dose, and see how the drug affects tumors.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- BAY2965501 (a drug that activates T-cells to fight cancer)
- What this could lead to
- If it works, this could point toward a new immunotherapy option for advanced solid tumors that are hard to treat.
- What could go wrong
- This is a very early Phase 1 trial, so the drug may not be effective or could cause serious side effects. It is also only tested in a small number of people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Antwerp University Hospital | Oncology Department
Antwerp, Antwerp, 2650, Belgium
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Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518172, China
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000, China
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Clinica Universidad De Navarra | Madrid | Oncologia
Madrid, 28027, Spain
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Clinica Universidad De Navarra | Pamplona | Oncologia
Pamplona, Madrid, 31008, Spain
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Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
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Ghent University Hospital | Drug Research Unit Department
Ghent, East Flanders, 9000, Belgium
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Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, Greater London, SE1 9RT, United Kingdom
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Hospital Hm Nou Delfos | Oncologia
Barcelona, 08023, Spain
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Hospital Universitari Vall D Hebron | Oncologia
Barcelona, 08035, Spain
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Hospital Universitario Hm Sanchinarro | Oncologia
Madrid, 28050, Spain
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National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
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Oxford University Hospitals NHS Foundation Trust | Churchill Hospital - Oncology
Oxford, Oxfordshire, OX3 7LE, United Kingdom
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Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, SM2 5PT, United Kingdom
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START | San Antonio
San Antonio, Texas, 78229, United States
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Samsung Medical Center - Oncology Department
Seoul, 06351, South Korea
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Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
Denver, Colorado, 80218, United States
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
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Severance Hospital, Yonsei University Health System - Oncology Department
Seoul, 03722, South Korea
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Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, Zhejiang, 310016, China
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can your own immune cells beat advanced cancer?
- Tumor DNA mapping may unlock personalized cancer therapies
- Can a new drug combo shrink Hard-to-Treat tumors?
- Can a pill outsmart Tumors' defenses?
- Can a new immune drug outsmart Hard-to-Treat tumors?
- Can a protein calm the immune System's overreaction to cancer treatment?