BAY2862789
DrugOral administration, solution or tablets
NCT Number: NCT05858164
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
The Kinghorn Cancer Centre - Medical Oncology Department, Darlinghurst, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-- Dose escalation: All solid cancers, except primary central nervous system cancers.
Exclusion criteria
Oral administration, solution or tablets
Time frame: Up to 90 days after the last administration of the study treatment
Adverse events (AEs) will be considered treatment-emergent if they have started or worsened after first administration of study treatment up to 90 days after the last administration of study treatment.
Time frame: Up to 21 days after the first administration of the study treatment
Time frame: Up to 2 years
RDE: as determined by safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) and efficacy data
Time frame: from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Time frame: Pre-dose and up to 24 hours after Day 16 in Cycle 1
Time frame: from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Time frame: Pre-dose and up to 24 hours after Day 16 in Cycle 1
Time frame: Up to 2 years
ORR is defined as the proportion of participants whose best overall response is either a confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) (investigator assessed).
Time frame: Up to 2 years
DCR is defined as the percentage of participants whose best overall response was either CR, PR, or SD, considering the requirement for confirmation of CR and PR.
CR stands for complete response. PR stands for partial response. SD stands for stable disease.
Time frame: Up to 2 years
DOR is defined as the time from the first documented objective response of PR or CR, whichever occurs earlier, to disease progression or death (if death occurs before progression is documented).
PR stands for partial response. CR stands for complete response.
Time frame: Up to 6 months
PFS is defined as the time from the start of study treatment to the date of first observed disease progression by investigator assessment or death due to any cause, if death occurs before progression is documented.
Time frame: Up to 12 months
OS is defined as the time from the start of study treatment to death due to any cause.
Time frame: Up to 2 years
Time frame: Up to 2 years
Bayer
Industry
An Open-label, Phase 1, First-in-human, Dose Escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics, and Tumor Response Profile of the Diacylglycerol Kinase Alpha Inhibitor (DGKαi) BAY 2862789 in Participants With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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