← Back to Search

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 tests a new drug, BAY 2416964, combined with pembrolizumab to treat advanced cancers like head and neck, lung, and bladder cancer. BAY 2416964 helps the immune system fight cancer by blocking a protein that hinders immune cells. The study aims to find the safest and most effective dose of this combination.

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).
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.
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
Select...
I am 18 years old or older.
Select...
My advanced cancer has not responded to, or I cannot tolerate, all known beneficial treatments.
Select...
My cancer has worsened despite treatment with specific immune therapy.
Select...
My cancer is either lung, head and neck, or bladder cancer.
Select...
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:
Select...
I have or had lung inflammation that needed steroids.
Select...
I have not had a severe infection in the last 4 weeks.
Select...
I have an immune system disorder or am on medication that weakens my immune system.
Select...
I have not needed treatment for an autoimmune disease in the last 2 years.
Select...
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2416964
The incidence of TEAEs including TESAEs
Secondary study objectives
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468
40%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
SORE THROAT
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg

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
Pembrolizumab
2017
Completed Phase 2
~2070
BAY2416964
2019
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,260 Previous Clinical Trials
25,309,398 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
~6 spots leftby Mar 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.
Back to top