New cancer drug BAY2965501 enters first human tests

NCT ID NCT05614102

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 284 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have measurable disease per Response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) as assessed by the local site investigator. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Participants with histologically confirmed diagnosis of a solid tumor (specifications for the different parts of the study below) will be enrolled onto this study: •Dose escalation (for monotherapy or BAY 2965501 and pembrolizumab combination cohorts): All solid cancers, except primary central nervous system cancers •Dose escalation (for BAY 2965501 with pembrolizumab and platinum-based regimen combination cohorts): All solid cancers, except primary central nervous system cancers, (including Non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), cervical, endometrial, triple negative breast cancer) that are eligible for standard of care platinum-based regimen and for whom this trial is a reasonable option for them. * The following tumor types may be recruited to the monotherapy expansion cohorts: o Non-small cell lung cancer (NSCLC) * The following tumor types may be recruited to the BAY 2965501 and pembrolizumab combination expansion cohorts: * NSCLC: participants who are treatment-naïve in the incurable disease setting. * NSCLC: Participants with metastatic NSCLC (confirmed histologically or cytologically) * Gastric/GEJ adenocarcinoma * other tumor types may be explored based on emerging data * The following tumor types will be recruited to the BAY 2965501 and pembrolizumab with platinum-based regimen combination expansion cohorts: * All solid cancers, except primary central nervous system cancers (including NSCLC, HNSCC, cervical, endometrial, triple negative breast cancer), that are eligible for standard of care platinum-based regimen Exclusion Criteria: * Previous therapy with a DGK inhibitor other than BAY 2965501 or BAY 2862789 is prohibited. Participants previously treated with BAY 2965501 or BAY 2862789 must have progressed on that DGK inhibitor (given as monotherapy and not have discontinued for toxicity) to be eligible for the combination of BAY 2965501 and pembrolizumab cohorts only. * Has received a prior therapeutic regimen containing an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or an agent directed to another co-stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher infusion-related adverse event (irAE). * Participants with new brain metastases on screening brain MRI/CT. Previously treated brain metastases that are progressive at screening compared to a brain MRI/CT at least 4 weeks earlier are also excluded. Participants with known previously treated brain metastases, which are radiologically stable compared to a CT/MRI scan at least 4 weeks earlier, clinically stable and without the requirement of steroid treatment for at least 14 days prior to the first dose of study treatment * Primary central nervous system malignancy or presence of leptomeningeal disease (i.e., positive cerebrospinal fluid cytology or unequivocal radiological or clinical evidence of leptomeningeal involvement). * Participants with gastrointestinal conditions that may compromise oral absorption such as short bowel syndrome or active tumor-related bowel obstruction with ongoing symptoms compromising absorption over last 6 months.

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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.

Advanced solid tumors

Contacts and locations

Locations

Antwerp University Hospital | Oncology Department

Antwerp, Antwerp, 2650, Belgium
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, 518172, China
Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 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, East Flanders, 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, 06351, 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, Gyeonggi-do, 13620, South Korea
Severance Hospital, Yonsei University Health System - Oncology Department

Seoul, 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

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