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Aryl Hydrocarbon Receptor Inhibitor
BAY2416964 for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of cycle 2 (- 7 days), cycle 4 (-7 days), every 9 weeks (- 7 days) from cycle 5 to cycle 10 and every 4th cycle (- 7 days) from cycle 11 onwards. each cycle is 21 days.
Awards & highlights
Study Summary
This trial is testing a new drug, BAY2416964, to see if it is safe and effective against solid tumors that can't be cured by other drugs.
Who is the study for?
This trial is for adults with advanced solid tumors that haven't responded to existing treatments. Participants need measurable disease, proper organ and bone marrow function, a life expectancy of at least 12 weeks, and an ECOG status of 0-1. They can't join if they've had severe infections recently, active autoimmune diseases treated in the last two years, certain heart conditions or brain metastases requiring steroids.Check my eligibility
What is being tested?
The study tests BAY2416964's safety and effectiveness against solid tumors untreatable by current drugs. It aims to find the highest dose patients can take without serious side effects while assessing how their bodies handle the drug. BAY2416964 blocks a protein that may help immune cells fight tumor cells.See study design
What are the potential side effects?
Specific side effects aren't listed but generally include any adverse reactions participants might experience from taking BAY2416964 as it inhibits a key protein involved in immune response to cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of cycle 2 (- 7 days), cycle 4 (-7 days), every 9 weeks (- 7 days) from cycle 5 to cycle 10 and every 4th cycle (- 7 days) from cycle 11 onwards. each cycle is 21 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of cycle 2 (- 7 days), cycle 4 (-7 days), every 9 weeks (- 7 days) from cycle 5 to cycle 10 and every 4th cycle (- 7 days) from cycle 11 onwards. each cycle is 21 days.
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 (0 - t)] (t=6,12 or 24 dependent on the dosing regimen) of BAY2416964 after single and multiple-dose in Cycle 1
Maximal plasma exposure (Cmax) for once daily (QD) dosing of BAY2416964 after single-dose and multiple-dose in Cycle 1.
Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2416964
+3 moreSecondary outcome measures
Change from baseline in AhR target gene expression in whole blood after ex-vivo stimulation
Cytokine measurements, e.g. IL-6 (immunoassay), in whole blood after ex-vivo stimulation.
Objective response rate (ORR) by RECIST 1.1
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose expansion of BAY2416964 in tumor type specificExperimental Treatment1 Intervention
Patients with NSCLC, HNSCC
Group II: Dose escalation of BAY2416964Experimental Treatment1 Intervention
Approximately 8 dose levels of BAY2416964 are planned
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY2416964
2019
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,900 Total Patients Enrolled
Media Library
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.
How many people have been granted admittance to this medical trial?
"This clinical trial, sponsored by Bayer and conducted across CHU de Québec-Hôpital de l'Enfant-Jésus in Québec, Quebec and Cross Cancer Institute in Edmonton, Alberta requires a total of 143 eligible participants."
Answered by AI
Has the FDA sanctioned BAY2416964 for public consumption?
"Our team at Power judged BAY2416964's safety to be a 1, due to the limited amount of data that has been collected on efficacy and safety during this early-stage clinical trial."
Answered by AI
Are members of the public still eligible to participate in this experiment?
"Affirmative. According to clinicaltrials.gov, enrollment for this research project is still ongoing since it was first posted on August 15th 2019 and last edited November 4th 2022. A total of 143 patients need to be recruited from 8 distinct medical sites."
Answered by AI
How many research sites are engaged in this clinical experiment?
"Currently, 8 medical centres are running this trial; these sites can be found in Québec, Edmonton and Greenville. To minimize the amount of travelling required to participate, it is best to choose a location closest to you."
Answered by AI
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