Sevabertinib for Liver Dysfunction

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bayer

Must not be taking: CYP3A4 inducers/inhibitors, Anti-coagulants

Disqualifiers: Uncontrolled diseases, GI disorders, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body processes a new cancer drug, sevabertinib, in people with liver problems compared to those with healthy livers. Researchers seek participants with moderate liver issues (consistent with cirrhosis) and healthy volunteers with normal liver function. The information gathered will help determine if cancer patients with liver disease require different doses of sevabertinib. Participants will take a single dose and stay in a research clinic for 5 days to monitor drug absorption and any side effects. This study is crucial for ensuring that cancer treatments are safe and effective for patients with liver conditions. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot use strong or moderate CYP3A4 inducers or inhibitors, certain drugs affecting absorption, supplements, herbal remedies, anti-coagulants, or recreational drugs. If you are on opioids or benzodiazepines, you must withhold them from 12 hours before to 12 hours after taking the study drug.

Is there any evidence suggesting that sevabertinib is likely to be safe for humans?

Studies have shown that sevabertinib is generally tolerable for patients. In research involving individuals with advanced lung cancer and HER2 mutations, the treatment proved manageable. While some side effects occurred, they were not too severe for most participants.

Researchers continue to study sevabertinib, particularly in individuals with liver problems. This focus is crucial because liver issues can affect how the body processes medicine. The trial is in an early stage, so researchers are still assessing its safety. Early studies often aim to understand side effects and determine the right dose.

Sevabertinib has shown promise in treating certain cancers, but it remains under investigation. Those considering joining a trial will receive close monitoring to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sevabertinib is unique because it targets liver dysfunction differently than standard treatments like supportive care, lifestyle changes, or medications that manage symptoms. Unlike these options, Sevabertinib acts specifically on the molecular pathways involved in liver impairment, potentially offering a more targeted approach. Researchers are excited because this could lead to improved outcomes for patients with moderate hepatic impairment by directly addressing the underlying causes rather than just alleviating symptoms.

What evidence suggests that sevabertinib might be an effective treatment for cancers with HER2 mutations?

Studies have shown that sevabertinib can help treat cancers with specific genetic changes, such as HER2 mutations. In one study with previously untreated patients, 71% responded well to the drug, with some experiencing complete cancer remission. This trial will examine how liver problems affect the drug's processing in the body. Participants will be divided into two groups: those with moderate hepatic impairment and those with normal hepatic function. Early findings suggest sevabertinib effectively targets certain cancer cells, making it a promising option for people with these specific cancer types. Understanding how the drug works in individuals with liver issues will help ensure its safety and effectiveness for more patients. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This study is for adults with moderate liver problems (Child-Pugh B) and healthy volunteers matched by age, sex, and weight. Participants will take a single dose of the experimental cancer drug Sevabertinib to see how liver disease affects its processing in the body.

Inclusion Criteria

My weight is at least 50 kg and my BMI is between 18 and 40.

Signed Informed Consent Form (ICF)

I am not pregnant, breastfeeding, and cannot become pregnant.

Exclusion Criteria

Consumption of specified foods within 2 weeks prior to study intervention administration

Special diets preventing standard meals during the study

Positive alcohol or drug screening tests

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 20 mg dose of sevabertinib and stay in the research clinic for 5 days for pharmacokinetic assessment and monitoring

1 week

5 days in-clinic stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Follow-up visits to ensure continued health and safety

What Are the Treatments Tested in This Trial?

Interventions

• Sevabertinib

Trial Overview The trial tests how a single oral dose of Sevabertinib is absorbed, metabolized, and eliminated in people with moderate liver impairment compared to those with normal liver function. Researchers aim to determine if dosage adjustments are necessary for patients with liver issues.

How Is the Trial Designed?

Group I: Arm B: Normal Hepatic Function Experimental Treatment 1 Intervention

Approximately 10 matched control participants for Arm A with normal hepatic function

Group II: Arm A: Moderate Hepatic Impairment Experimental Treatment 1 Intervention

Approximately 10 participants with moderate impaired hepatic function (Child-Pugh B) to achieve approximately 8 evaluable participants

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. clinicaltrials.bayer.com clinicaltrials.bayer.com/study/22988

Liver Diseases || Pharmacokinetics || Drug Metabolism A study evaluating how moderate liver impairment affects the absorption, distribution, metabolism, and elimination of sevabertinib after a single oral dose.

2. withpower.com withpower.com/trial/phase-1-pharmacokinetics-6-2025-3b65f

Sevabertinib for Liver Dysfunction This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).

3. clinconnect.io clinconnect.io/trials/NCT07102095

A Study Evaluating How Moderate Liver Impairment Affects This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10358256/

Systemic treatment in patients with Child–Pugh B liver ... Overall survival in patients with HCC and moderate liver dysfunction treated with sorafenib has been found to be only approximately 3–5 months.

5. cancernetwork.com cancernetwork.com/view/sevabertinib-monotherapy-elicits-durable-responses-in-her2-mutant-nsclc

Sevabertinib Monotherapy Elicits Durable Responses in ... In cohort F, which enrolled patients who were treatment-naïve (n = 73), the ORR by BICR was 71% (95% CI, 59%-81%), with 4% achieving CRs, 67% ...

6. onclive.com onclive.com/view/sevabertinib-induces-durable-response-in-advanced-her2-mutant-nsclc

Sevabertinib Induces Durable Response in Advanced ... Treatment with the oral TKI showed promising responses among 2 subgroups of patients with advanced, HER2-mutant non–small cell lung cancer.

7. mdanderson.org mdanderson.org/newsroom/research-newsroom/esmo-2025--oral-drug-demonstrates-promising-anti-tumor-activity-.h00-159780390.html

ESMO 2025: Oral drug demonstrates promising anti-tumor ... The oral targeted therapy sevabertinib led to tumor reduction and manageable side effects in patients with HER2-mutant non-small cell lung ...