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AhR Inhibitor

BAY 2416964 + Pembrolizumab for 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
Participant must be ≥18 years of age inclusive, at the time of signing the informed consent
Participants with histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease known to confer clinically meaningful benefit, or are intolerant to treatment, or refuse standard treatment
Screening 3 weeks
Treatment Varies
Follow Up at the end of cycle 2 (-7 days, each cycle is 21 days), cycle 4 (-7 days) and at the end of every third cycle (-7 days) from cycle 5 onwards
Awards & highlights

Study Summary

This trial is looking for a new way to treat cancer by using a drug to block a protein called Aryl Hydrocarbon Receptor (AhR). The study drug, BAY 2416964, is a small molecule which blocks the AhR allowing the body to use its immune response against the cancer cells. Researchers think that BAY 2416964 given together with a cancer treatment called pembrolizumab may help shrink tumors in people with cancer.

Who is the study for?
Adults with advanced solid tumors, including specific types of lung, bladder, and head and neck cancer that have worsened after standard treatments or who cannot tolerate such treatments. Participants must be over 18 years old with an ECOG performance status of 0 to 1 (indicating they are fully active or restricted in physically strenuous activity but ambulatory).Check my eligibility
What is being tested?
The trial is testing BAY 2416964 combined with pembrolizumab for safety, tolerability, the maximum safe dose level, how it affects the body and its effectiveness against cancer. The study has two parts: dose escalation to find the right dose and dose expansion using this determined dose.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to pembrolizumab's action on the immune system as well as any typical drug-related adverse events like nausea, fatigue or allergic reactions. Specific side effects related to BAY 2416964 are not detailed but will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 18 years old or older.
My advanced cancer has not responded to, or I cannot tolerate, all known beneficial treatments.
My cancer has worsened despite treatment with specific immune therapy.
My cancer is either lung, head and neck, or bladder cancer.
I am fully active or restricted in physically strenuous activity but can do light work.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of cycle 2 (-7 days, each cycle is 21 days), cycle 4 (-7 days) and at the end of every third cycle (-7 days) from cycle 5 onwards
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 2 (-7 days, each cycle is 21 days), cycle 4 (-7 days) and at the end of every third cycle (-7 days) from cycle 5 onwards for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2416964
The incidence of TEAEs including TESAEs
The severity of TEAEs including TESAEs
Secondary outcome measures
AUC(0-t) (t depend on the dosing regimen) of BAY2416964 after multiple-dose in Cycle 1
AUC(0-t) (t depend on the dosing regimen) of BAY2416964 after single-dose in Cycle 1
Cmax of BAY2416964 after multiple-dose in Cycle 1
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
Back pain
Shortness of Breath
Abdominal pain
Kidney Injury and/or Infection
Weight Loss
Malnutrition, Hypercalcemia and Weakness
Intractable pain, back pain, hip pain
Activated partial thromboplastin time prolonged
Pleural effusion
Atrial fibrillation with rapid ventricular response
Respiratory failure
Skin rash
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose expansion of BAY2416964 in tumor type specific cohortExperimental Treatment2 Interventions
To determine the RP2D of BAY2416964 in combination therapy with pembrolizumab. Participants will be enrolled in up to 3 tumor type-specific cohorts including relapsed/refractory non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and urothelial cancer.
Group II: Dose escalation of BAY2416964Experimental Treatment2 Interventions
Six dose levels of BAY 2416964 (as determined in the first in human mono-therapy study of BAY2416964) are planned in combination with standard dose Pembrolizumab.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1
Completed Phase 2

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,233 Previous Clinical Trials
25,326,270 Total Patients Enrolled

Media Library

Solid Tumors Research Study Groups: Dose escalation of BAY2416964, Dose expansion of BAY2416964 in tumor type specific cohort
Solid Tumors Clinical Trial 2023: BAY2416964 Highlights & Side Effects. Trial Name: NCT04999202 — Phase 1
BAY2416964 (AhR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04999202 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what disease states is BAY2416964 typically used to offer relief?

"BAY2416964 is a common medication for cancer treatment, and it has been found to be effective in the management of unresectable melanoma, microsatellite instability high (MSI-H), as well as disease progression after chemotherapy."

Answered by AI

How many venues are managing this experiment?

"The 6 participating medical centres are located in Austin, Detroit and Nashville among others. It is advisable to choose the clinic closest to you when signing up for this trial so as to reduce travel burden."

Answered by AI

Are recruiting efforts for this research endeavor ongoing?

"According to the information provided by clinicaltrials.gov, this research is currently looking for participants. The initial posting took place on August 30th 2021 and the most recent update was made November 14th 2022."

Answered by AI

Has any other research explored BAY2416964?

"Currently, there are 961 clinical trials underway researching BAY2416964. Of those studies, 122 have progressed to Phase 3. Although the majority of experiments related to this drug are conducted in Houston, Texas - across 35 743 different sites - investigations for BAY2416964 can be found all over the world."

Answered by AI

Does BAY2416964 pose any health risks to humans?

"The safety of BAY2416964 is rated at 1 due to the limited data available for this Phase 1 trial, which does not yet provide sufficient information about efficacy and security."

Answered by AI

What is the enrollment count for this trial at present?

"Affirmative, according to clinicaltrials.gov the medical trial that commenced on August 30th 2021 is actively enrolling. 78 participants are sought from 6 sites for this research study."

Answered by AI

Who else is applying?

What site did they apply to?
Henry Ford Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
~12 spots leftby Mar 2025