Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05858164
Registration number
NCT05858164
Ethics application status
Date submitted
5/05/2023
Date registered
15/05/2023
Titles & IDs
Public 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
Query!
Scientific title
An Open-label, Phase 1, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics, and Tumor Response Profile of the Diacylglycerol Kinase Alpha Inhibitor (DGKai) BAY 2862789 in Participants With Advanced Solid Tumors
Query!
Secondary ID [1]
0
0
2024-510998-26-00
Query!
Secondary ID [2]
0
0
22231
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
0
0
Query!
Non-small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - BAY2862789
Experimental: Dose Escalation - Participants will take BAY2862789 oral doses.
Experimental: Dose Expansion - Participants will take BAY2862789 oral doses. Dose Expansion starts after Dose Escalation.
Treatment: Drugs: BAY2862789
Oral administration, solution or tablets
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The number and severity of treatment-emergent adverse events (TEAEs)
Query!
Assessment method [1]
0
0
Adverse events (AEs) will be considered treatment-emergent if they have started or worsened after first administration of study treatment up to 90 days after the last administration of study treatment.
Query!
Timepoint [1]
0
0
Up to 90 days after the last administration of the study treatment
Query!
Primary outcome [2]
0
0
Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the Dose Escalation part of the study
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to 21 days after the first administration of the study treatment
Query!
Primary outcome [3]
0
0
Recommended phase 2 dose (RP2D)
Query!
Assessment method [3]
0
0
The RP2D will be defined in the expansion part based on multiple parameters (i.e., safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy). The final decision about the RP2D will be made by the Sponsor in consultation with the Investigators at the end of the expansion part.
Query!
Timepoint [3]
0
0
Up to 2 years
Query!
Primary outcome [4]
0
0
Maximum concentration (Cmax) BAY2862789 after single-dose
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Query!
Primary outcome [5]
0
0
Maximum concentration (Cmax) BAY2862789 after multiple-dose
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Pre-dose and up to 24 hours after Day 16 in Cycle 1
Query!
Primary outcome [6]
0
0
Area under the curve (AUC) BAY2862789 after single-dose
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Query!
Primary outcome [7]
0
0
Area under the curve (AUC) BAY2862789 after multiple-dose
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Pre-dose and up to 24 hours after Day 16 in Cycle 1
Query!
Secondary outcome [1]
0
0
Objective response rate (ORR)
Query!
Assessment method [1]
0
0
ORR is defined as the proportion of participants whose best overall response is either a confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) (investigator assessed).
Query!
Timepoint [1]
0
0
Up to 2 years
Query!
Secondary outcome [2]
0
0
Disease control rate (DCR)
Query!
Assessment method [2]
0
0
DCR is defined as the percentage of participants whose best overall response was either CR, PR, or SD, considering the requirement for confirmation of CR and PR.
CR stands for complete response. PR stands for partial response. SD stands for stable disease.
Query!
Timepoint [2]
0
0
Up to 2 years
Query!
Secondary outcome [3]
0
0
Duration of response (DOR)
Query!
Assessment method [3]
0
0
DOR is defined as the time from the first documented objective response of PR or CR, whichever occurs earlier, to disease progression or death (if death occurs before progression is documented).
PR stands for partial response. CR stands for complete response.
Query!
Timepoint [3]
0
0
Up to 2 years
Query!
Secondary outcome [4]
0
0
Progression-free survival (PFS) at 6 months
Query!
Assessment method [4]
0
0
PFS is defined as the time from the start of study treatment to the date of first observed disease progression by investigator assessment or death due to any cause, if death occurs before progression is documented.
Query!
Timepoint [4]
0
0
Up to 6 months
Query!
Secondary outcome [5]
0
0
Overall survival (OS) at 12 months
Query!
Assessment method [5]
0
0
OS is defined as the time from the start of study treatment to death due to any cause.
Query!
Timepoint [5]
0
0
Up to 12 months
Query!
Secondary outcome [6]
0
0
Activation of effector T memory cells
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to 2 years
Query!
Secondary outcome [7]
0
0
Ex vivo stimulated short-term activation of Interleukin 2 (IL2) and interferon-gamma
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to 2 years
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Factorial
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/08/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
2/03/2027
Query!
Actual
Query!
Sample size
Target
102
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
The Kinghorn Cancer Centre - Medical Oncology Department - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Princess Alexandra Hospital Australia - QLD
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
4102 - QLD
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Connecticut
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Michigan
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Mississippi
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New York
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Texas
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Utah
Query!
Country [8]
0
0
China
Query!
State/province [8]
0
0
Hubei
Query!
Country [9]
0
0
China
Query!
State/province [9]
0
0
Jilin
Query!
Country [10]
0
0
Israel
Query!
State/province [10]
0
0
Jerusalem
Query!
Country [11]
0
0
Israel
Query!
State/province [11]
0
0
Tel Aviv
Query!
Country [12]
0
0
Japan
Query!
State/province [12]
0
0
Chiba
Query!
Country [13]
0
0
Korea, Republic of
Query!
State/province [13]
0
0
Chungcheongbugdo
Query!
Country [14]
0
0
Korea, Republic of
Query!
State/province [14]
0
0
Gyeongsangnam-do
Query!
Country [15]
0
0
Korea, Republic of
Query!
State/province [15]
0
0
Seoul Teugbyeolsi
Query!
Country [16]
0
0
Korea, Republic of
Query!
State/province [16]
0
0
Seoul
Query!
Country [17]
0
0
Spain
Query!
State/province [17]
0
0
Barcelona
Query!
Country [18]
0
0
Spain
Query!
State/province [18]
0
0
Malaga
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bayer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05858164
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Bayer Clinical Trials Contact
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
(+)1-888-84 22937
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05858164