Brief Summary
Researchers are looking for a better way to treat people who have advancedat a late stage, far along solid tumors including a specific kind of lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (non-small cell lung cancer, NSCLC).
Advanced solid tumors are types of cancer that have spread to nearby tissuea group of cells that work together to perform a function, lymph nodessmall bean-shaped structures that filters harmful substances from lymph fluid, and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments.
BAY2862789 works by blocking an enzyme in T-cells, thereby activating them. T-cells are a type of immune cell that are known to have an anti-cancer effect.
The main purpose of this first-in-human study is to learn:
- how safe different doses of BAY2862789 are,
- the degree to which medical problems caused by BAY2862789 can be tolerated (also called tolerability),
- what maximum amount (dosethe amount of medication taken) can be given, and
- how BAY2862789 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 BAY2862789 for each dose level. These medical problems are also referred to as adverse events. An adverse event is considered “serious” when it leads to death, puts the participants’ lives at riskthe possibility that something bad will happen, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important.
- the (average) total level of BAY2862789 in the bloodthe red bodily fluid that transports oxygen and other nutrients around the body (also called AUC) after intake of single and multiple doses.
- the (average) highest level of BAY2862789 in the blood (also called Cmax) after intake of single and multiple doses.
Doctors and their team 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 BAY2862789.
The dose escalation will be done to find the most appropriate dose that can be given. For this, each participant will receive one of the increasing doses of Bay 2862789. More groups might be investigated based on new data that emerges. For this, each participant will receive one of the increasing doses of BAY2862789.
Participants in the study will take the study treatment until their tumor gets worse (also known as ‘disease progression’), until they 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 test (screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.
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 cancer status using CT (computed tomography) or MRI (magnetic resonance imaging)a type of medical imaging that uses radiowaves, a strong magnet and computer technology to create detailed images of the body and, if needed, bone scans
- take tumor samples (if required)
- pregnancy test
The treatment period ends with a visit no later than 7 days after the last BAY2862789 dose. The study doctors and their team will check the participants’ health and any changes in cancer about 30 and 90 days after the last dose and every 12 weeks thereafter. This follow-up period ends if the cancer worsens, if a new anti-cancer treatment is started, 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 BAY2862789 beyond the duration of this study might be possible.
Inclusion Criteria:
- Capable of giving signed informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- Be ≥18 years of age on day of signing informed consent.
- Have measurable disease per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) as assessed by the local site investigator.
- Have an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 to 1.
- Participants with a histologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of a solid tumor that have exhausted available treatments known to be beneficial for this tumor type or for whom these treatments are not acceptable and for whom this trial is a reasonable option for them, will be enrolled onto this study. Appropriate molecular profiling of tumors should have been performed according to local national guidelines prior to trial entry. Specifications for the different parts of the study are below:– Dose escalation: All solid cancers, except primary central nervous system cancers.
- Provision of archival tumor sample at baseline is mandatory for all participants in escalation, and expansion cohorts.
- Participants must be willing to undergo mandatory paired biopsies of tumor (pre- and on- treatment).
- Have adequate organ function.
- Agree to use contraception during the treatment period and for at least 6 months after the last dose of study treatment.