BAY2862789 for Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
Researchers are looking for a better way to treat people who have advanced solid tumors including a specific kind of lung cancer (non-small cell lung cancer, NSCLC). Advanced solid tumors are types of cancer that 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. 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 (dose) 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 risk, 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 blood (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 (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) 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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain treatments like systemic anti-cancer therapy or investigational agents within 4 weeks before starting the trial. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug BAY2862789 for non-small cell lung cancer?
The research highlights the role of GLK (also known as MAP4K3) in promoting lung cancer metastasis and recurrence, suggesting that targeting this pathway could be beneficial. Although not directly about BAY2862789, these findings imply that inhibiting GLK might help reduce cancer spread and improve outcomes in non-small cell lung cancer.12345
Eligibility Criteria
Adults with advanced solid tumors, including non-small cell lung cancer (NSCLC), who have tried all beneficial treatments or find them unsuitable. They must be in good physical condition, agree to use contraception for 6+ months post-treatment, and provide tumor samples. NSCLC patients should've had PD1/L-1 and platinum therapy; those with certain mutations are ineligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BAY2862789 in a dose escalation format to determine the maximum tolerated dose and assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with health checks and cancer status assessments
Open-label extension (optional)
Participants may continue treatment with BAY2862789 if they benefit from it, beyond the main study duration
Treatment Details
Interventions
- BAY2862789
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD