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Advanced Non-small Cell Lung CancerPhase 1NCT06221475

A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants

A Phase 1 study testing BAY2927088 coated tablet 10 mg, [14C]-BAY2927088 solution for infusion and [14C]-BAY2927088 oral solution in people with Advanced Non-small Cell Lung Cancer and EGFR Mutation, run by Bayer at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
What is being tested?
BAY2927088 coated tablet 10 mg, [14C]-BAY2927088 solution for infusion and [14C]-BAY2927088 oral solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteNetherlands
Study dates
25 Jan 2024to 8 May 2024
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 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Capable of giving signed informed consent
  • Participant must be 18 or age of legal maturity to 55 years of age inclusive, at the time of signing the informed consent
  • Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac, and neurologic examination
  • Body mass index (BMI) within the range [18 - 30] kg/m^2 (inclusive), with bodyweight above/equal to 50 kg
  • Male
  • Study participants of reproductive potential must agree to use adequate contraception when sexually active during the study period and for at least 3 months after the last dose of study intervention, and refrain from donating sperm during this period
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  • Participant must have venous access sufficient to allow blood sampling as required by the protocol
  • Participant must be willing to undergo multiple blood draws as required by the protocol
  • Participant must be willing to comply with dietary and fluid requirements during the treatment period (including abstaining from alcohol use)
  • Ability to understand and follow study-related instructions

Who cannot join

  • Existing relevant diseases of vital organs (e.g., liver diseases, heart diseases, gastrointestinal diseases, interstitial lung disease), central nervous system (for example seizures) or other organs (e.g., diabetes mellitus)
  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention will not be normal
  • Any relevant diseases within 4 weeks prior to the first study intervention administration as judged by the investigator
  • A medical history of risk factors for Torsades de pointes (e.g., family history of long QT syndrome) or other clinically significant arrhythmias as judged by the investigator
  • Known history of hypersensitivity (or known allergic reaction) to BAY2927088-related compounds, or any components of the formulation
  • History of known or suspected malignant tumors
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  • Participants with any type of psychiatric disorder, especially any mood disorders including medical history with suicidal ideation and/or suicide attempts, which may disable the participant to consent
  • Any condition which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 3 days) constipation or symptomatic prostatic hypertrophy
  • Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work or during participation in a clinical study in the period of 1 year prior to screening
  • Participant will be excluded when he participated in another study with a radiation burden of 0.1 - 1 mSv (inclusive) in the period of 1 year prior to screening; 1.1 - 2 mSv (inclusive) in the period of 2 years prior to screening; 2.1 - 3 mSv (inclusive) in the period of 3 years prior to screening, etc. (add 1 year per 1 mSv)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • ICON plc

    Groningen, 9728NZ

Other trials in Netherlands

About this study

Official title: A Two-part, Single Center, Open-label Study to Investigate the Pharmacokinetics, Metabolic Disposition, Mass Balance and Absolute Bioavailability of BAY 2927088 in Healthy Male Participants

Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body.

Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment works by blocking the mutated EGFR and HER2 protein present in NSCLC cells and may help stop the further spread of NSCLC.

Read more

BAY2927088 is under development, once it is approved, it may help treat people with NSCLC.

The participants of this study will be healthy men and will have no benefit from the administration of BAY2927088. However, the study will provide important information for the design of subsequent studies with BAY2927088 in people with NSCLC.

The participants in this study will get the non-radiolabeled and radio-labeled study treatment BAY2927088 in the form of tablets and solution by mouth and as an intravenous infusion in the arm. By radiolabeling the study treatment, researchers can track its movement and breakdown in the body of the participants. During the study, the study team will do physical examinations, take medical history, ask the participants questions about their smoking or alcohol consumption habits and other medications used, check vital signs such as blood pressure, heart rate, body temperature and the number of breaths taken per minute (respiratory rate), take blood and urine samples, do HIV (human immunodeficiency virus), hepatitis and optional COVID-19 tests per local regulations, and examine heart health using electrocardiogram (ECG).

Each study participant will go through a first test phase (screening) of up to 28 days before the start of treatment. The study will have two parts. In part 1, the study participants will take a single dose of the non-radiolabeled study treatment in the form of tablets by mouth 30 minutes following a light meal. They will then receive the radiolabeled study treatment as an intravenous infusion in the arm over 15 minutes. After 2 days of washout, the same group of participants will move on to Part 2 of the study. They will take a single dose of the radio-labeled study treatment as a solution by mouth 30 minutes after a light meal. The participants and the study team know what treatment the participants will take. The total duration of the study will be approximately 8 weeks per participant, including an in house stay of approximately 23 days and 22 nights. There will be a final examination on the last day of their in-house stay before the participants are discharged and go home.

The study doctors and their team will contact the participant to learn about the participant's health until the participant completes the study.

Being tested
BAY2927088 coated tablet 10 mg, [14C]-BAY2927088 solution for infusion, [14C]-BAY2927088 oral solution
Keywords
NSCLC, TKI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY2927088 coated tablet 10 mgDrug

    4 coated tablets (10 mg) per single dose 30 min after a light meal

  • [14C]-BAY2927088 solution for infusionDrug

    IV infusion 15 min ending at 2 hours oral post-dose

  • [14C]-BAY2927088 oral solutionDrug

    After a light meal

Study groups in NCT06221475
Study groupRoleWhat they receive
Healthy male participants from NetherlandsExperimentalIn Part 1, participants will receive a single dose of 40 mg of BAY2927088 as oral tablets on Study Day 1 approximately 30 min after a light meal, they will then receive a single dose of a microtracer not exceeding 100 ug of [14C]-BAY2927088 and 37 kilo becquerel (kBq) [1000 nano Curie (nCi)] of 14C will be administered intravenously (IV) as a 15 min infusion ending at the expected median time to maximum concentration (tmax) for the tablet (2 hours oral post-dose). After 2 days of washout, participants will move on to Part 2. In Part 2, on Study Day 1 approximately 30 min after a light meal, all enrolled participants will receive a single dose of 40 mg BAY2927088 containing approximately 3.7 MBq (100 µCi) [14C]-BAY 2927088 administered as an oral solution
Receives: Drug: BAY2927088 coated tablet 10 mg; Drug: [14C]-BAY2927088 solution for infusion; Drug: [14C]-BAY2927088 oral solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. For Part 1: Absolute bioavailability (F) as percent F (%F) after oral administration as oral to IV ratio of AUC/D (Area under the concentration curve per dose)

    Measured: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose

  2. For Part 1: AUC of BAY2927088 and [14C]-BAY2927088

    Measured: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose

  3. For Part 1: AUC/D of BAY2927088 and [14C]-BAY2927088

    Measured: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose

  4. For Part 1: Cmax (maximum concentration) of BAY2927088 and [14C]-BAY2927088

    Measured: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose

  5. For Part 1: Cmax/D of BAY2927088 and [14C]-BAY2927088

    Measured: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose

  6. For Part 2: Amount of BAY2927088 and its metabolites excreted in urine (%AEur), in feces (%AEfec), and in vomit as a percent of the dose (%AEvom, if applicable)

    Based on radioactivity excreted in urine and feces, and vomit as a percentage of the dose to assess mass balance of total radioactivity

    Measured: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose

  7. For Part 2: AUC of total radioactivity in plasma and whole blood. (AUC(0-tlast) will be used as primary parameter if mean AUC(tlast-∞) >20% of AUC)

    Measured: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose

  8. For Part 2: Cmax of total radioactivity in plasma and whole blood

    Measured: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose

  9. For Part 2: AUC of BAY2927088 in plasma. (AUC[0-tlast] will be used as primary parameter if mean AUC[tlast-∞] >20% of AUC)

    Measured: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose

  10. For Part 2: Cmax of BAY2927088 in plasma

    Measured: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose

Secondary outcomes (1)

  1. Number of participants with treatment-emergent adverse events (TEAE) and severity of treatment-emergent adverse events

    Measured: From dosing up to 15 days after last dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study start25 Jan 2024
  3. Primary completion5 Apr 2024
  4. Study completion8 May 2024

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm open-label, single dose study in healthy male participants
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06221475
Sponsor's protocol ID
22249
Other IDs
2022-502771-38-00
Status last verified
May 2024
First submitted
15 Jan 2024
Last updated
28 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY2927088 coated tablet 10 mg, [14C]-BAY2927088 solution for infusion and [14C]-BAY2927088 oral solution in people with Advanced Non-small Cell Lung Cancer and EGFR Mutation, run by Bayer at 1 site in Netherlands.

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 10 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 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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?

For Part 1: Absolute bioavailability (F) as percent F (%F) after oral administration as oral to IV ratio of AUC/D (Area under the concentration curve per dose) (time frame: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06221475.

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 28 Jun 2024.

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