A First-in-human Study to Learn How Safe the Study Treatment BAY2965501 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, and How it Acts on Different Tumors in Part

• Status: Recruiting
• Trial end date: 2026-08-10

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 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,

• the degree to which medical problems caused by BAY2965501 can be tolerated (also called tolerability),

• what maximum amount can be given, and

• how it moves into, through and out of the body.

To answer this, the researchers will look at:

• the number and severity of medical problems participants have after taking BAY2965501 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 first part, called dose escalation, is done to find the most appropriate dose that can be given in the second part. For this, each participant will receive one of the increasing doses of BAY2965501. They will take BAY2965501 daily by mouth.

All participants in the second part, called dose expansion, will receive the most appropriate dose from the first part daily as tablet by mouth. Participants in both parts of the study, will take the study treatment until the tumor gets worse (also known as 'disease progression'), the participants have medical problems, until they leave the study, or until the study is terminated.

Each participant will be in the study for several months, including a screening phase of up to 28 days, few months of treatment depending on the participant's benefit, and a follow up phase after the end of treatment. The following approximate numbers of visits to the study site are planned: two during the screening phase, six in the first treatment month, one to three per month in the following periods.

Participants in part 2 will be assigned to one of four groups depending on cancer characteristics.

Study procedures described below may vary between these groups.

During the study, the study team will:

• take blood and urine samples

• do physical examinations

• check vital signs such as blood pressure, heart rate, body temperature

• examine heart health using ECG (electrocardiogram)

• check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan

• take tumor samples (if required)

The treatment period ends with a visit no later than 7 days after the last BAY2965501 dose. About 30 and 90 days after the last dose and every 12 weeks thereafter, the study team will check the participants' health and any changes in cancer. This follow-up period ends with worsening of the cancer, start of new anti-cancer therapy, or until the participant leaves the study. In addition, the study doctors and their team will contact the participant every 12 weeks to learn about the participant's survival. This ends no later than 12 months after the last participant started treatment or by the end of the study, whichever comes first.

If the study participant benefits from treatment, continuation of treatment with BAY2965501 beyond the duration of this study might be possible.

• Phase: Phase 1

Details

• Lead Sponsor: Bayer