What side effects are associated with this type of intervention?

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy often causes side effects such as nausea, vomiting, hair loss, and fatigue. Targeted therapies, which include drugs like tyrosine kinase inhibitors, can lead to side effects like diarrhea, liver problems, and skin rashes. Immunotherapy, which boosts the body's immune response against cancer, can cause immune-related side effects such as inflammation of healthy tissues, leading to conditions like colitis, pneumonitis, and dermatitis. For treatments similar to Aryl Hydrocarbon Receptor Inhibition, specific side effects are not well-documented, but they may include immune-related adverse effects given their mechanism of action.

What prior FDA approvals exist?

The FDA has approved various treatments for solid tumors, including targeted therapies and immunotherapies. Targeted therapies such as tyrosine kinase inhibitors (e.g., erlotinib for non-small cell lung cancer) and PARP inhibitors (e.g., olaparib for ovarian and breast cancers) have been significant. Immunotherapies, including checkpoint inhibitors like pembrolizumab and nivolumab, have also been approved for multiple solid tumors, enhancing the body's immune response against cancer cells. While specific Aryl Hydrocarbon Receptor inhibitors like BAY2416964 are still under investigation, these existing therapies highlight the ongoing advancements in targeted and immune-based cancer treatments.

What other types of research exist?

Promising novel alternatives to BAY2416964 for solid tumor patients include: 1) Pembrolizumab plus chemotherapy, which has shown efficacy in metastatic non-small-cell lung cancer (KEYNOTE-189 trial). 2) PARP inhibitors like Veliparib, which have demonstrated effectiveness in BRCA-associated metastatic breast cancer. 3) Niraparib, another PARP inhibitor, which has shown activity in metastatic castration-resistant prostate cancer with HRR gene alterations (MAGNITUDE trial). 4) Olaparib, combined with abiraterone, which has shown significant prolongation in radiographic progression-free survival in metastatic castration-resistant prostate cancer (PROPEL trial).

← Back to Search

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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 more

Secondary 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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

BAY2416964 works by inhibiting the Aryl Hydrocarbon Receptor (AhR), a protein that plays a role in immune cell response to tumor cells, thereby enhancing the body's immune response against the tumor. Common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells; targeted therapy, which blocks specific molecules involved in tumor growth and progression; and immunotherapy, which boosts the body's immune system to fight cancer. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment strategy, potentially improving outcomes and minimizing side effects.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Disparity between Inter-Patient Molecular Heterogeneity and Repertoires of Target Drugs Used for Different Types of Cancer in Clinical Oncology.Targeting the androgen receptor in the management of castration-resistant prostate cancer: rationale, progress, and future directions.

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,247 Previous Clinical Trials

25,333,507 Total Patients Enrolled

Media Library

BAY2416964 (Aryl Hydrocarbon Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04069026 — Phase 1

~14 spots leftby Jun 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.