Advanced Solid TumorsPhase 1NCT05858164
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
A Phase 1 study testing BAY2862789 in people with Advanced Solid Tumors and Non-small Cell Lung Cancer, run by Bayer at 16 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Non-small Cell Lung Cancer
- What is being tested?
- BAY2862789
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 7 Aug 2023to 26 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Provision of archival tumor sample at baseline is mandatory for all participants in escalation, and expansion cohorts.
- Participants must be willing to undergo mandatory paired biopsies of tumor (pre- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
South Korea5 sites
Chungbuk National University Hospital | Hematology and Oncology
Chungcheongbuk-do, North Chungcheong, 28644
Gyeongsang National University Hospital | Oncology
Jinju, Gyeongsangnam-do, 52727
Seoul National University Hospital | Oncology
Jongno -Gu, Seoul, 03080
Asan Medical Center | Oncology
Seoul, 05505
Seoul St Mary's Hospital | Oncology
Seoul, 06591
United States3 sites
AdventHealth medical Group Oncology Research at Celebration
Celebration, Florida, 34747
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, Michigan, 48202
START | San Antonio
San Antonio, Texas, 78229
Australia2 sites
The Kinghorn Cancer Centre - Medical Oncology Department
Darlinghurst, New South Wales, 2010
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 4102
China2 sites
Jilin Cancer Hospital
Changchun, Jilin, 130000
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, 430030
Israel2 sites
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001
Tel- Aviv Sourasky Medical Center - Nephrology
Tel Aviv, 6423906
Spain2 sites
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, 08035
Hospital Universitario Virgen De La Victoria | Oncologia
Málaga, 29010
About this study
Official title: An Open-label, Phase 1, First-in-human, Dose Escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics, and Tumor Response Profile of the Diacylglycerol Kinase Alpha Inhibitor (DGKαi) BAY 2862789 in Participants With Advanced Solid Tumors
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.
Read more
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 dose escalation will be done to find the most appropriate dose that can be given. For this, each participant will receive one of the increasing doses of Bay 2862789. More groups might be investigated based on new data that emerges. For this, each participant will receive one of the increasing doses of BAY2862789.
Participants in 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.
- Conditions
- Advanced Solid Tumors, Non-small Cell Lung Cancer
- Being tested
- BAY2862789
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2862789Drug
Oral administration, solution or tablets
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants will take BAY2862789 oral doses. Receives: Drug: BAY2862789 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of treatment-emergent adverse events (TEAEs)
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.
Measured: Up to 90 days after the last administration of the study treatment
Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the Dose Escalation part of the study
Measured: Up to 21 days after the first administration of the study treatment
Recommended Dose for Expansion (RDE)
RDE: as determined by safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) and efficacy data
Measured: Up to 2 years
Maximum concentration (Cmax) BAY2862789 after single-dose
Measured: from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Maximum concentration (Cmax) BAY2862789 after multiple-dose
Measured: Pre-dose and up to 24 hours after Day 16 in Cycle 1
Area under the curve (AUC) BAY2862789 after single-dose
Measured: from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Area under the curve (AUC) BAY2862789 after multiple-dose
Measured: Pre-dose and up to 24 hours after Day 16 in Cycle 1
Secondary outcomes (7)
Objective response rate (ORR)
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).
Measured: Up to 2 years
Disease control rate (DCR)
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.
Measured: Up to 2 years
Duration of response (DOR)
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.
Measured: Up to 2 years
Progression-free survival (PFS) at 6 months
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.
Measured: Up to 6 months
Overall survival (OS) at 12 months
OS is defined as the time from the start of study treatment to death due to any cause.
Measured: Up to 12 months
Activation of effector T memory cells
Measured: Up to 2 years
Ex vivo stimulated short-term activation of Interleukin 2 (IL2) and interferon-gamma
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start7 Aug 2023
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858164
- Sponsor's protocol ID
- 22231
- Other IDs
- 2024-510998-26-00
- Status last verified
- 1 Oct 2025
- First submitted
- 5 May 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, First-in-human, Dose Escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics, and Tumor Response Profile of the Diacylglycerol Kinase Alpha Inhibitor (DGKαi) BAY 2862789 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05858164
- Acronym / sponsor ID
- 22231
- Conditions
- Advanced Solid Tumors, Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 dose escalation will be done to find the most appropriate dose that can be given. For this, each participant will receive one of the increasing doses of Bay 2862789. More groups might be investigated based on new data that emerges. For this, each participant will receive one of the increasing doses of BAY2862789.
Participants in 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: BAY2862789Participants will take BAY2862789 oral doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY2862789Oral administration, solution or tablets | Drug | Dose Escalation |
Primary outcome
The number and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 90 days after the last administration of the study treatment
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.
Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the Dose Escalation part of the study
Time frame: Up to 21 days after the first administration of the study treatment
Recommended Dose for Expansion (RDE)
Time frame: Up to 2 years
RDE: as determined by safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) and efficacy data
Maximum concentration (Cmax) BAY2862789 after single-dose
Time frame: from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Maximum concentration (Cmax) BAY2862789 after multiple-dose
Time frame: Pre-dose and up to 24 hours after Day 16 in Cycle 1
Area under the curve (AUC) BAY2862789 after single-dose
Time frame: from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Area under the curve (AUC) BAY2862789 after multiple-dose
Time frame: Pre-dose and up to 24 hours after Day 16 in Cycle 1
7 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Progression-free survival (PFS) at 6 months
Time frame: Up to 6 months
Overall survival (OS) at 12 months
Time frame: Up to 12 months
Activation of effector T memory cells
Time frame: Up to 2 years
Ex vivo stimulated short-term activation of Interleukin 2 (IL2) and interferon-gamma
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2862789 in people with Advanced Solid Tumors and Non-small Cell Lung Cancer, run by Bayer at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea, United States, Australia, China, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and severity of treatment-emergent adverse events (TEAEs) (time frame: Up to 90 days after the last administration of the study treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.