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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
Must not have
History of pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
Severe infections (CTCAE v.5 Grade ≥ 3) within 4 weeks before the first study intervention administration
Timeline
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

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
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I am 18 years old or older.
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My advanced cancer has not responded to, or I cannot tolerate, all known beneficial treatments.
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My cancer has worsened despite treatment with specific immune therapy.
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My cancer is either lung, head and neck, or bladder cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had lung inflammation that needed steroids.
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I have not had a severe infection in the last 4 weeks.
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I have an immune system disorder or am on medication that weakens my immune system.
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I have not needed treatment for an autoimmune disease in the last 2 years.
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My cancer has spread to my brain or the lining around my brain.

Timeline

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
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY2416964
2019
Completed Phase 1
~80
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,251 Previous Clinical Trials
25,336,869 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
~8 spots leftby Mar 2025
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