Zanzalintinib for Liver Disease

Recruiting at 1 trial location

Overseen By Exelixis Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Exelixis

Disqualifiers: Cardiac events, Organ transplant, Encephalopathy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called zanzalintinib to observe its behavior in the body when taken by individuals with moderate liver dysfunction, compared to healthy individuals. Researchers aim to understand how the body processes the drug through a single dose. Individuals with stable liver issues for over six months and no recent severe symptoms may qualify. Healthy individuals matching the age and smoking status of those with liver issues can also participate. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that zanzalintinib has been studied for safety in humans, but detailed information from past studies remains limited. In another study, researchers tested zanzalintinib for safety when combined with another drug in patients with a specific type of colorectal cancer, providing some safety data, though not detailed here.

This current study is in the early phase, so detailed safety information might be limited. Early phase trials focus on understanding how the body processes the treatment and checking for immediate side effects. As this is an early phase trial, researchers are carefully monitoring and assessing zanzalintinib's safety in humans.

Overall, while earlier research has shown some promising signs, the complete safety profile of the treatment is still under development. Participants should know that ongoing monitoring is part of the trial process to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for liver disease, which often include medications like antivirals or corticosteroids, Zanzalintinib offers a novel approach by targeting specific pathways related to liver function. Researchers are excited about Zanzalintinib because it has a unique mechanism of action that may improve liver health more effectively and quickly than current options. Additionally, its oral administration makes it more convenient for patients compared to more invasive treatments. This combination of a new target and easier delivery method is why Zanzalintinib holds promise as an innovative option for those with liver disease.

What evidence suggests that zanzalintinib might be an effective treatment for liver disease?

Research has shown that zanzalintinib might help treat liver problems. In earlier studies, patients with advanced liver cancer had positive results with zanzalintinib. They experienced longer periods without cancer progression and lived longer overall when zanzalintinib was combined with other treatments. In this trial, participants will receive a single oral dose of zanzalintinib to understand how the drug works in the body. These early results are encouraging for its potential effectiveness. ^{1 4 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Exelixis

Are You a Good Fit for This Trial?

This trial is for adults with moderate liver dysfunction (Child-Pugh Class B) due to chronic, stable hepatic insufficiency with features of cirrhosis. Participants should not have donated blood recently and must match the age, sex, and smoking status ratios of others in the study. They need normal bone marrow function and no significant medical issues aside from liver impairment.

Inclusion Criteria

My bone marrow is functioning well.

I don't have any major health issues apart from my current condition.

I smoke 10 or fewer cigarettes a day and can limit it further during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of zanzalintinib tablet on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zanzalintinib

Trial Overview The study tests how a single dose of Zanzalintinib behaves in the body (its pharmacokinetics) among people with moderate liver problems compared to those with healthy livers. It aims to understand differences in drug processing due to liver function.

How Is the Trial Designed?

Group I: Moderate HI Experimental Treatment 1 Intervention

Participants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1.

Group II: Matched Healthy Control Active Control 1 Intervention

Matched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1.

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07042919

Zanzalintinib in Second Line and Beyond for the Treatment ... Giving zanzalintinib may be safe, tolerable, and/or effective in treating patients with advanced liver cancer. SECONDARY OBJECTIVES: I.

2. ir.exelixis.com ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-phase-1b2-stellar-001

Press Release - Exelixis, Inc. Both progression-free survival (PFS) and overall survival (OS) were numerically improved by the addition of atezolizumab to zanzalintinib.

3. clinconnect.io clinconnect.io/trials/NCT06962332

Pharmacokinetics (PK) and Safety of Zanzalintinib in The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06962332

Study Details | NCT06962332 | Pharmacokinetics (PK) and ... The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11485978/

STELLAR-303: randomized phase III study of zanzalintinib ... In the phase Ib REGONIVO study, treatment with regorafenib plus nivolumab resulted in objective responses in 9 of 25 (36%) patients with mCRC, but among the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06962332?intr=xl092&rank=9

Pharmacokinetics (PK) and Safety of Zanzalintinib in ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06962332/pharmacokinetics-pk-and-safety-of-zanzalintinib-in-participants-with-moderate-hepatic-impairment-hi

Pharmacokinetics (PK) and Safety of Zanzalintinib in ... The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver ...

8. go.drugbank.com go.drugbank.com/conditions/DBCOND0166870

Hepatic Impairment (HI) (DBCOND0166870) Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI). Zanzalintinib. treatment, 1, recruiting. NCT04332432. A ...