Trial Title:
A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults
NCT ID:
NCT04999202
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Pembrolizumab
Conditions: Keywords:
Non-small cell lung cancer (NSCLC)
Head and neck squamous cell carcinoma (HNSCC)
Urothelial Cancer
Advanced cancer
Immunotherapy
Immuno oncology
Aryl Hydrocarbon Receptor inhibitor(AhRi)
Aryl Hydrocarbon Receptor
Pembrolizumab
aPD1
Checkpoint inhibitor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BAY2416964
Description:
Oral, twice or three times daily
Arm group label:
Dose escalation of BAY2416964
Intervention type:
Drug
Intervention name:
BAY2416964
Description:
The highest dose determined safe in combination with pembrolizumab in the dose escalation
part or a lower dose. More than one dose may be explored in the dose expansion.
Arm group label:
Dose expansion of BAY2416964 in tumor type specific cohort
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered as a dose of 200 mg using a 30-minute IV infusion every 3 weeks
Arm group label:
Dose escalation of BAY2416964
Arm group label:
Dose expansion of BAY2416964 in tumor type specific cohort
Summary:
Researchers are looking for a better way to treat advanced solid cancers including head
and neck cancer, lung cancer and bladder cancer.
In some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent
immune cells from fighting tumor cells. 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.
The main aims of this study are to find for BAY 2416964 in combination with
pembrolizumab,
- how safe this drug combination is
- how it affects the body (also referred to as tolerability)
- the highest amount of BAY 2416964 that can be given in combination with
pembrolizumab without too many side effects.
The researchers will also study the action of BAY 2416964 in combination with
pembrolizumab against the cancer.
The participants in this study will get BAY 2416964 and pembrolizumab. BAY 2416964 will
be given by mouth. Pembrolizumab will be given as an intravenous (IV) infusion. An IV
infusion is given through a needle into a vein.
This study will have two parts. The first part will help find the most appropriate dose
that can be given in the second part.
Each participant of the first, so called dose escalation part, will be assigned to one
specific dose group for BAY 2416964. The amount of BAY 2416964 that is given changes
step-wise from one group to the next. The dose of pembrolizumab will always be the same.
The participants of the second, so called dose expansion part, will receive the most
appropriate dose of BAY 2416964 found in the first part.
During the study, the participants will receive the treatment in 3-week periods called
cycles. In each cycle, the participants will in general get pembrolizumab once and BAY
2416964 in a daily schedule. These 3-week cycles will be repeated throughout the trial.
The participants can take the study treatment until their cancer gets worse, until they
have medical problems, or until they leave the trial. Participants will have around 4
visits in each cycle. Some of the visits can also be done via phone.
During the study, the study doctors and their team will:
- take blood and urine samples
- check if the participants' cancer has changed in size using computed tomography
scans or magnetic resonance imaging scans of the participants' tumors
- check the participants' overall health
- ask the participants questions about how they are feeling and what adverse events
they are having.
An adverse event is any medical problem that a participant has during a study. Doctors
keep track of all adverse events that happen in studies, even if they do not think the
adverse events might be related to the study treatments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant must be ≥18 years of age inclusive, at the time of signing the informed
consent.
- Participants with following histologically or cytologically confirmed advanced solid
tumors that have progressed after treatment with all available therapies for
metastatic disease that are known to confer clinically meaningful benefit, or are
intolerant to treatment, or refuse standard treatment.
- Dose Escalation: all solid tumor types
- Tumor type-specific Expansion cohorts:
- NSCLC
- HNSCC with primary location in oropharynx, oral cavity, hypopharynx or
larynx
- Urothelial Cancer
- Participants must have progressed on treatment with an anti-PD-1/L1 monoclonal
antibody (mAb) administered either as monotherapy, or in combination with other
checkpoint inhibitors or other therapies.
- Have measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion Criteria:
- Severe (Common terminology criteria for adverse events (CTCAE) v.5 Grade ≥ 3)
infections within 4 weeks before the first study intervention administration
- Active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy
- Has active Central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that
required steroids or has current pneumonitis/interstitial lung disease.
- Cardiac disease as specified in the protocol
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Altamonte Springs
Zip:
32701
Country:
United States
Facility:
Name:
Florida Cancer Specialists & Research Institute
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Facility:
Name:
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Address:
City:
Detroit
Zip:
48202
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Texas Oncology- Austin Midtown
Address:
City:
Austin
Zip:
78705
Country:
United States
Facility:
Name:
Virginia Cancer Specialists, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Sperimentazioni Cliniche
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Address:
City:
Milano
Zip:
20133
Country:
Italy
Facility:
Name:
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
Address:
City:
Milano
Zip:
20141
Country:
Italy
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Facility:
Name:
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Facility:
Name:
Belfast City Hospital
Address:
City:
Belfast
Zip:
BT12 7AB
Country:
United Kingdom
Facility:
Name:
Freeman Hospital
Address:
City:
Newcastle
Zip:
NE7 7DN
Country:
United Kingdom
Start date:
August 30, 2021
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Bayer
Agency class:
Industry
Source:
Bayer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04999202
https://clinicaltrials.bayer.com/
