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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Provision of archival tumor sample at baseline is mandatory for all participants in escalation, and expansion cohorts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new way to treat advanced solid tumors, including a particular type of lung cancer (non-small cell lung cancer, NSCLC), to see if it is safe and effective.
Who is the study for?
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.Check my eligibility
What is being tested?
BAY2862789 is being tested for safety at various doses, tolerability, maximum dose levels, and how it affects the body and tumors. It's a first-in-human study involving two parts: finding an appropriate dose then expanding that dose to more participants as a tablet until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
Possible side effects of BAY2862789 include adverse events ranging from mild to serious such as organ inflammation, allergic reactions requiring hospitalization or causing disability. Participants' health will be closely monitored throughout the study for any treatment-related medical problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I can provide a sample of my tumor for the study.
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I am 18 years old or older.
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I have a solid tumor cancer, not including brain cancer.
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My cancer can be measured by standard health scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the curve (AUC) BAY2862789 after multiple-dose
Area under the curve (AUC) BAY2862789 after single-dose
Maximum concentration (Cmax) BAY2862789 after multiple-dose
+4 moreSecondary outcome measures
Activation of effector T memory cells
Disease control rate (DCR)
Duration of response (DOR)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Participants will take BAY2862789 oral doses. Dose Expansion starts after Dose Escalation.
Group II: Dose EscalationExperimental Treatment1 Intervention
Participants will take BAY2862789 oral doses.
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Who is running the clinical trial?
BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,675 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer that is growing or was treated in the last 3 years.I am fully active or restricted in physically strenuous activity but can do light work.I have new brain metastases found on a recent MRI/CT scan.My tumor was tested for specific genetic changes as per guidelines.I can provide a sample of my tumor for the study.I have lung inflammation or scarring.I agree to have two tumor biopsies for the study.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last 14 days.I am able to understand and sign the consent form.I have a solid tumor and no other treatment options are suitable for me.I stopped a cancer treatment due to a severe side effect.I haven't had cancer treatment or investigational drugs in the last 4 weeks.I have recovered from any side effects of previous radiation therapy and do not need steroids.I am 18 years old or older.I have not had a blood transfusion in the last 2 weeks.I have received a transplant from another person.I have been treated with a DGK inhibitor before.I have not received a live vaccine in the last 30 days.I have a brain tumor or cancer in the lining of my brain and spinal cord.I have a gut condition affecting how my body absorbs medicine.My organs are functioning well.I am currently being treated for an infection.I have a solid tumor cancer, not including brain cancer.My cancer can be measured by standard health scans.I have NSCLC and have been treated with PD1/L-1 and platinum chemotherapy. I do not have EGFR or ALK mutations.You have an ongoing autoimmune disease, like inflammatory bowel disease, that needed strong medication in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
- Group 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project still open to new participation?
"This clinical trial, first posted on May 16th 2023 and last updated on the 5th of May 2023, is no longer accepting participants. Nonetheless, there are an abundance of 1893 medical studies presently recruiting patients for their trials."
Answered by AI
Are there any other healthcare facilities in this state executing the research project?
"At the moment, this clinical trial is accessible from 6 different sites. These locations include Jackson, Houston and San Antonio in addition to 3 other cities. It's best for participants to select the closest centre available so as to minimize their commuting requirements."
Answered by AI
Has dose escalation been given the green light by regulatory agencies?
"To ensure the safety of individuals, our team at Power assigned Dose Escalation a score of 1 on its scale due to limited evidence supporting both efficacy and safety."
Answered by AI
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