Trial Title:
A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors
NCT ID:
NCT05614102
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Pembrolizumab
Conditions: Keywords:
Solid tumors
Non-small cell lung cancer
NSCLC
Gastroesophageal junction adenocarcinoma
GEJ adenocarcinoma
Renal cell carcinoma
RCC
Melanoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BAY2965501
Description:
Daily oral application
Arm group label:
Dose escalation of BAY2965501
Arm group label:
Dose expansion of BAY2965501
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
In combination group 200mg as infusion every 3 weeks
Arm group label:
Dose escalation of BAY2965501+pembrolizumab
Arm group label:
Dose expansion of BAY2965501 +pembrolizumab
Summary:
Researchers are looking for a better way to treat people who have advanced solid tumors.
Advanced solid tumors are types of cancer that may have spread to nearby tissue, lymph
nodes, and/or to distant parts of the body and that are unlikely to be cured or
controlled with currently available treatments. This study focuses on certain types of
skin cancer, kidney cancer, stomach cancer, and lung cancer.
The study treatment BAY2965501 is currently under development as monotherapy or in
combination with a drug named pembrolizumab for the treatment of people with advanced
solid tumors.
BAY2965501 blocks an enzyme in T-cells to activate them. T-cells are a type of immune
cell that are known to have an anti-cancer effect and BAY2965501 is a potential new
immunotherapy.
The main purpose of this first-in-human study is to learn:
- how safe different doses of BAY2965501 are when given as a single drug or in
combination,
- the degree to which medical problems caused by BAY2965501 when given as a single
drug or in combination, can be tolerated (also called tolerability),
- what maximum amount can be given as a single drug or in combination, and
- how it moves into, through and out of the body as a single drug or in combination.
To answer this, researchers will look at:
- the number and severity of medical problems participants have after taking
BAY2965501 as a single drug or in combination for each dose level. These medical
problems are also referred to as adverse events.
- the (average) total level of BAY2965501 in the blood (also called AUC) after intake
of single and multiple doses
- the (average) highest level of BAY2965501 in the blood (also called Cmax) after
intake of single and multiple doses Doctors keep track of all medical problems that
participants have during the study, even if they do not think the medical problem
might be related to the study treatment.
In addition, the researchers want to know if and how the participants' tumors change
after taking BAY2965501.
The study will have two parts. The first part, called dose escalation, is done to find
the most appropriate dose that can be given in the second part. For this, participants
will be assigned to receive one of the planned doses and schedules of BAY2965501 as
single drug or participants will be assigned to one of the increasing doses of BAY2965501
in combination with 200mg pembrolizumab. All participants will take BAY2965501 by mouth.
Additionally, in the combination group, pembrozilumab will be given.
In the second part, called dose expansion, all participants in the single drug group will
receive up to 2 of the most appropriate doses of BAY2965501 from the 1st part as tablet
by mouth. The participants in the combination group will receive the most appropriate
dose of BAY2965501 from the first part.
Participants in both parts of the study, will take the study treatment until the tumor
gets worse (also known as 'disease progression'), or until the participants have medical
problems. In general, the study treatment is planned for a maximum of 35 cycles.
Each participant will be in the study for several months, including a screening phase of
up to 28 days, few months of treatment depending on the participant's benefit, and a
follow up phase after the end of treatment. The following approximate numbers of visits
to the study site are planned: two during the screening phase, six in the first treatment
month, one to three per month in the following periods.
Participants in part two will be assigned to one of 3 groups depending on cancer
characteristics.
Study procedures described below may vary between these groups.
During the study, the study team will:
- take blood and urine samples
- do physical examinations
- check vital signs such as blood pressure, heart rate, body temperature
- examine heart health using ECG (electrocardiogram)
- check if the participants' cancer has grown and/or spread using CT (computed
tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan
- take tumor samples (if required)
The treatment period ends with a visit no later than 7 days after the last BAY2965501
dose in the single drug and combination group. About 30 and 90 days after the last dose
and every 12 weeks thereafter, the study team will check the participants' health and any
changes in cancer. This follow-up period ends with worsening of the cancer, start of new
anti-cancer therapy, or until the participant leaves the study. In addition, the study
doctors and their team will contact the participant every 12 weeks to learn about the
participant's survival. This ends no later than 12 months after the last participant
started treatment or by the end of the study, whichever comes first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have measurable disease per Response evaluation criteria in solid tumors version 1.1
(RECIST 1.1) as assessed by the local site investigator.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Participants with histologically confirmed diagnosis of a solid tumor
(specifications for the different parts of the study below) will be enrolled onto
this study:
• Dose escalation: All solid cancers, except primary central nervous system cancers
- The following tumor types will be recruited to the monotherapy expansion cohorts:
- Non-small cell lung cancer (NSCLC)
- Gastric/Gastroesophageal Junction (GEJ) adenocarcinoma
- The following tumor types will be recruited to the BAY 2965501 and pembrolizumab
combination expansion cohorts:
- NSCLC: participants with tumors that are TPS score ≥50% PDL-1 high (based on
local historical testing) and are eligible for standard of care anti-PD(L)-1
monotherapy in the first line incurable treatment setting.
- NSCLC
- Gastric/GEJ adenocarcinoma
Exclusion Criteria:
- Previous therapy with a DGK inhibitor is prohibited for monotherapy cohorts
(participants previously treated with BAY 2965501 or BAY 2862789 must have
progressed on that DGK inhibitor (and not discontinued for toxicity) to be eligible
for combination).
- Has received a prior therapeutic regimen containing an anti-PD-1, anti-PD-L1, or
anti PD-L2 agent or an agent directed to another co-stimulatory or co-inhibitory
T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that
treatment due to a Grade 3 or higher infusion-related adverse event (irAE).
- Participants with new brain metastases on screening brain MRI/CT. Previously treated
brain metastases that are progressive at screening compared to a brain MRI/CT at
least 6 weeks earlier are also excluded. Participants with known previously treated
brain metastases, which are radiologically stable compared to a CT/MRI scan at least
6 weeks earlier, clinically stable and without the requirement of steroid treatment
for at least 14 days prior to the first dose of study treatment may be eligible.
- Primary central nervous system malignancy or presence of leptomeningeal disease
(i.e., positive cerebrospinal fluid cytology or unequivocal radiological or clinical
evidence of leptomeningeal involvement).
- Participants with gastrointestinal conditions that may compromise oral absorption
such as short bowel syndrome or active tumor-related bowel obstruction with ongoing
symptoms compromising absorption over last 6 months.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute at HealthONE
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
MedStar Georgetown University Hospital
Address:
City:
Washington
Zip:
20007-2113
Country:
United States
Status:
Withdrawn
Facility:
Name:
UF Health Cancer Center
Address:
City:
Gainesville
Zip:
32610-3633
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
START | San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Tranquil Clinical Research
Address:
City:
Webster
Zip:
77598
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Antwerp University Hospital | Oncology Department
Address:
City:
Antwerpen
Zip:
2650
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Institut Jules Bordet - Clinique D'Oncology
Address:
City:
Bruxelles
Zip:
1070
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Ghent University Hospital | Drug Research Unit Department
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Recruiting
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Address:
City:
Shenzhen
Zip:
518172
Country:
China
Status:
Not yet recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Completed
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
3080
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
135-710
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
START | Barcelona
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron - Institut d'Oncologia - Grupo de Tumores Toracicos y Cancer de Cabeza y Cuello
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro Location
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Universidad de Navarra - Centro de Investigacion Medica Aplicada (CIMA)
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Churchill Hospital
Address:
City:
Oxford
Zip:
OX3 7LJ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Marsden NHS Trust (Surrey)
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Freeman Hospital
Address:
City:
Newcastle
Zip:
NE7 7DN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
November 4, 2022
Completion date:
August 10, 2026
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/NCT05614102
https://clinicaltrials.bayer.com/study/21948
