NCT05858164
Who may be able to join
Who might be able to join this trial:
- You must be 18 years of age or older at the time of signing the consent form.
- You must be able to understand and sign a consent form agreeing to take part in the trial.
- You must have a solid tumor cancer (not a brain or spinal cord cancer) that can be measured on a scan, as assessed by the trial team.
- You must be well enough to carry out daily activities with little to no limitation (as measured by a standard health scale used by doctors — confirm with trial site).
- You must have a solid tumor cancer that has been confirmed by a tissue sample (biopsy), and your cancer must have either stopped responding to available treatments, or those treatments are not suitable for you.
- Your tumor must have been tested using appropriate genetic or molecular tests before joining, in line with your country's guidelines.
- You must provide a stored tissue sample from your tumor at the start of the trial.
- You must be willing to have two biopsies (tissue samples taken from your tumor) — one before treatment starts and one during treatment.
- Your kidneys, liver, and other organs must be working well enough to take part (confirm with trial site).
- You must agree to use contraception during treatment and for at least 6 months after your last dose of the study treatment.
Who may not be able to join:
- You have previously received an organ or tissue transplant from another person.
- You have previously been treated with a type of drug called a DGK inhibitor (confirm with trial site).
- You previously received certain immunotherapy drugs (such as PD-1, PD-L1, or PD-L2 blockers, or similar treatments targeting the immune system) and had to stop because of a severe or life-threatening reaction related to your immune system.
- You have received cancer treatment (including experimental treatments) within the past 4 weeks, or within 5 half-lives of the drug — whichever is shorter, or certain growth-factor medicines within the past 4 weeks.
- You are still experiencing side effects from previous radiotherapy (radiation treatment), are taking steroid medicines to manage those effects, or have had radiation-related lung problems.
- You have had a blood transfusion within the 2 weeks before starting treatment.
- You have received a live vaccine within 30 days before your first dose of the study drug.
- You are currently taking part in, or have recently taken part in, another clinical trial using an experimental drug or device within the past 4 weeks.
- You have a condition that weakens your immune system, or you are taking steroid or other immune-suppressing medicines regularly within 7 days before starting the study drug.
- You have another cancer (separate from the one being treated in this trial) that is still growing or has needed treatment within the last 3 years.
- You have new cancer spread to the brain found on a scan at the start of the trial.
- Your cancer started in the brain or spinal cord, or has spread to the lining of the brain or spinal cord.
- You have a digestive condition (such as short bowel syndrome or a blockage in your bowel) that may affect how your body absorbs medicines taken by mouth, with ongoing symptoms in the last 6 months.
- You have an active autoimmune disease (such as inflammatory bowel disease) that has needed medical treatment in the past 2 years.
- You currently have lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease).
- You have an active infection that requires treatment with medicines given throughout your body (such as antibiotics given by drip or tablet).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
The number and severity of treatment-emergent adverse events (TEAEs); Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the Dose Escalation part of the study; Recommended Dose for Expansion (RDE); Maximum concentration (Cmax) BAY2862789 after single-dose; Maximum concentration (Cmax) BAY2862789 after multiple-dose; Area under the curve (AUC) BAY2862789 after single-dose; Area under the curve (AUC) BAY2862789 after multiple-dose
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.