New cancer drug BAY2965501 enters first human tests

NCT ID NCT05614102

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

melanoma neoplasm non-small cell lung carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Antwerp University Hospital | Oncology Department

    Antwerp, 2650, Belgium

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, 518172, China

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100000, China

  • Clinica Universidad De Navarra | Madrid | Oncologia

    Madrid, 28027, Spain

  • Clinica Universidad De Navarra | Pamplona | Oncologia

    Pamplona, Madrid, 31008, Spain

  • Freeman Hospital

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

  • Ghent University Hospital | Drug Research Unit Department

    Ghent, 9000, Belgium

  • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

    London, Greater London, SE1 9RT, United Kingdom

  • Hospital Hm Nou Delfos | Oncologia

    Barcelona, 08023, Spain

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035, Spain

  • Hospital Universitario Hm Sanchinarro | Oncologia

    Madrid, 28050, Spain

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • Oxford University Hospitals NHS Foundation Trust | Churchill Hospital - Oncology

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Royal Marsden NHS Trust (Surrey)

    Sutton, Surrey, SM2 5PT, United Kingdom

  • START | San Antonio

    San Antonio, Texas, 78229, United States

  • Samsung Medical Center - Oncology Department

    Seoul, 135-710, South Korea

  • Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's

    Denver, Colorado, 80218, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620, South Korea

  • Severance Hospital, Yonsei University Health System - Oncology Department

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

    Hangzhou, Zhejiang, 310016, China

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States