Trial Title:
A First-in-human Study to Learn How Safe the Study Treatment BAY2862789 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, and How it Acts on Different Tumors in Participants With Advanced Solid Tumors
NCT ID:
NCT05858164
Condition:
Advanced Solid Tumors
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BAY2862789
Description:
Oral administration, solution or tablets
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Summary:
Researchers are looking for a better way to treat people who have advanced solid tumors
including a specific kind of lung cancer (non-small cell lung cancer, NSCLC).
Advanced solid tumors are types of cancer that 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.
BAY2862789 works by blocking an enzyme in T-cells, thereby activating them. T-cells are a
type of immune cell that are known to have an anti-cancer effect.
The main purpose of this first-in-human study is to learn:
- how safe different doses of BAY2862789 are,
- the degree to which medical problems caused by BAY2862789 can be tolerated (also
called tolerability),
- what maximum amount (dose) can be given, and
- how BAY2862789 moves into, through and out of the body.
To answer this, the researchers will look at:
- the number and severity of medical problems participants have after taking
BAY2862789 for each dose level. These medical problems are also referred to as
adverse events. An adverse event is considered "serious" when it leads to death,
puts the participants' lives at risk, requires hospitalization, causes disability,
causes a baby being born with medical problems or is otherwise medically important.
- the (average) total level of BAY2862789 in the blood (also called AUC) after intake
of single and multiple doses.
- the (average) highest level of BAY2862789 in the blood (also called Cmax) after
intake of single and multiple doses.
Doctors and their team 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 BAY2862789.
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 of the study. For this,
each participant will receive one of the increasing doses of BAY2862789.
All participants in the second part of the study, called dose expansion, will receive the
most appropriate dose identified from the first part of the study, as tablet by mouth.
Participants in both parts of the study, will take the study treatment until their tumor
gets worse (also known as 'disease progression'), until they have medical problems, until
they leave the study, or until the study is terminated.
Each participant will be in the study for several months, including a test (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.
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 cancer status using CT (computed tomography) or MRI (magnetic resonance
imaging) and, if needed, bone scans
- take tumor samples (if required)
- pregnancy test
The treatment period ends with a visit no later than 7 days after the last BAY2862789
dose. The study doctors and their team will check the participants' health and any
changes in cancer about 30 and 90 days after the last dose and every 12 weeks thereafter.
This follow-up period ends if the cancer worsens, if a new anti-cancer treatment is
started, 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.
If the study participant benefits from treatment, continuation of treatment with
BAY2862789 beyond the duration of this study might be possible.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Capable of giving signed informed consent
- Be ≥18 years of age on day of signing informed consent.
- Have measurable disease per Response Evaluation Criteria in Solid Tumours 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 a histologically confirmed diagnosis of a solid tumor that have
exhausted available treatments known to be beneficial for this tumor type or for
whom these treatments are not acceptable and for whom this trial is a reasonable
option for them, will be enrolled onto this study. Appropriate molecular profiling
of tumors should have been performed according to local national guidelines prior to
trial entry. Specifications for the different parts of the study are below:
-- Dose escalation: All solid cancers, except primary central nervous system
cancers.
- Non-small cell lung cancer (NSCLC): Participants with NSCLC must have received an
approved PD1/L-1 containing regimen and platinum chemotherapy, as applicable.
Participants with known targetable genomic aberrations should have received
available targeted drugs deemed appropriate by the investigator. (apart from NSCLC
participants with endothelial growth factor receptor [EGFR] or alkaline phosphatase
[ALK] mutations who will not be eligible).
- Provision of archival tumor sample at baseline is mandatory for all participants in
escalation, and expansion cohorts.
- Participants recruited to expansion cohorts must be willing to undergo mandatory
paired biopsies of tumor (re and on treatment).
- Have adequate organ function.
- Agree to use contraception during the treatment period and for at least 6 months
after the last dose of study treatment.
Exclusion Criteria:
- Had an allogeneic tissue/solid organ transplant.
- Previous therapy with a diacylglycerol kinase (DGK) inhibitor
- Has received a prior therapeutic regimen containing an anti-programmed cell death
protein 1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or
anti-programmed cell death 1 ligand 2 (anti PD-L2) agent or an agent directed to
another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137) and was discontinued from
that treatment regimen due to a Grade 3 or higher immune related adverse event
(irAE) or any toxicity that was life-threatening.
- Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks or 5 half-lives, whatever is shorter, prior to treatment. Growth
factor treatments such as granulocyte colony-stimulating factor (G-CSF) must have
been discontinued 4 weeks prior to entering the study.
- Participants must have recovered from previous radiation-related toxicities, not
require corticosteroids, and not have had radiation pneumonitis.
- Participants cannot have had a blood transfusion within 2 weeks of starting therapy.
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose
of study treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior to the first dose
of study drug.
- Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years.
- Participants with new brain metastases on screening brain magnetic resonance
imaging/computed tomography (MRI/CT).
- Primary central nervous system malignancy or presence of leptomeningeal disease.
- 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.
- Has an active autoimmune disease including inflammatory bowel disease that has
required systemic treatment in past 2 years.
- Current pneumonitis / interstitial lung disease.
- Has an active infection requiring systemic therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale Smilow Cancer Hospital Phase I Unit
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Withdrawn
Facility:
Name:
AdventHealth medical Group Oncology Research at Celebration
Address:
City:
Celebration
Zip:
34747
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Mississippi Medical Center | Shafi Group
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Weill Cornell Medical College
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Withdrawn
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
START | San Antonio
Address:
City:
San Antonio
Zip:
78229-3307
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics | START Rocky Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Withdrawn
Facility:
Name:
The Kinghorn Cancer Centre - Medical Oncology Department
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Princess Alexandra Hospital Australia
Address:
City:
QLD
Zip:
4102
Country:
Australia
Status:
Recruiting
Facility:
Name:
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Hadassah Hebrew University Hospital Ein Kerem
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel-Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju-si
Zip:
52727
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
3080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Address:
City:
Seoul
Zip:
137-701
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Institut Català d'Oncologia Hospitalet
Address:
City:
Hospitalet de Llobregat
Zip:
08907
Country:
Spain
Status:
Not yet 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:
Instituto de Investigacion Biomedica de Malaga (IBIMA) - sede Hospital Universitario Virgen de la Victoria (HUVV)
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Start date:
August 7, 2023
Completion date:
March 2, 2027
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/NCT05858164
https://clinicaltrials.bayer.com/study/22231/
