Inavolisib for Liver Disease

Recruiting at 3 trial locations

Overseen By Reference Study ID Number: GP45942 https://forpatients.roche.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Opioids

Disqualifiers: Diabetes, Tuberculosis, Alcoholism, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, inavolisib, to assess its behavior in the body and its safety for individuals with liver problems. It will compare results among three groups: those with moderate liver issues, those with severe liver issues, and healthy individuals with normal liver function. Suitable candidates include those with ongoing liver problems causing cirrhosis but not cancer or recent severe disease changes. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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

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

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

Research has shown that inavolisib has been tested for safety in earlier studies. In one study, 98.8% of patients taking inavolisib experienced at least one side effect, but these were usually mild to moderate. No specific evidence links inavolisib to liver problems or allergic reactions, which is reassuring for those concerned about serious side effects.

Since this trial is in the early stages (Phase 1), researchers are still closely monitoring the treatment's safety. However, testing in other studies suggests that inavolisib might be well-tolerated. These findings offer some reassurance about its safety for those considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for liver disease that often focus on managing symptoms or slowing disease progression, inavolisib is unique because it targets specific cellular pathways directly involved in the disease's progression. Inavolisib is a PI3K inhibitor, which means it works by blocking an enzyme involved in cell growth and survival, potentially reducing liver damage more effectively than current options. Researchers are excited about inavolisib because this targeted approach could lead to more precise and possibly faster-acting treatments, offering hope for better outcomes in patients with varying degrees of liver function.

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

Research has shown that inavolisib may help treat certain cancers. Studies have found it can reduce the risk of cancer progression by 57% in some patients. While inavolisib may temporarily raise liver enzyme levels, it has not been linked to serious liver damage. This treatment targets a specific protein that aids cancer cell growth. Although limited information exists on its use for liver disease, its mechanism suggests potential benefits. Participants in this trial will receive a single oral dose of inavolisib, with different cohorts based on hepatic function to evaluate its effects. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with stable liver disease, specifically those with moderate to severe hepatic impairment. They must have a BMI between 18 and 40 kg/m^2, weigh at least 45 kg, test negative for HIV and hepatitis B & C (unless they've cleared the virus), and agree to use contraception. Women cannot be pregnant or breastfeeding. Healthy participants with normal liver function are also needed for comparison.

Inclusion Criteria

I have long-term, stable liver problems with signs of cirrhosis.

I have tested negative for HIV.

My BMI is between 18 and 40, and I weigh at least 45 kg.

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 inavolisib on Day 1

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics after receiving the dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inavolisib

Trial Overview The study is testing how a single oral dose of Inavolisib behaves in the body (its pharmacokinetics) among people with different levels of liver health. It will compare results from those with moderate or severe liver problems to healthy individuals to assess safety and tolerability.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1

Group II: Cohort 2 Experimental Treatment 1 Intervention

Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1

Group III: Cohort 1 Experimental Treatment 1 Intervention

Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/n/livertox/Inavolisib/

Inavolisib - LiverTox - NCBI Bookshelf - NIH Inavolisib is associated with transient elevations in serum aminotransferase levels during therapy but has not been linked to episodes of clinically apparent ...

2. itovebi-hcp.com itovebi-hcp.com/efficacy/trial-information.html

INAVO120 Clinical Trial Information | Itovebi™ (inavolisib) INAVO120: A phase 3, randomized, double-blind, placebo-controlled, multicenter, global study evaluating the efficacy and safety of Itovebi (inavolisib) + ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03006172

Study Details | NCT03006172 | To Evaluate the Safety, ... This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a ...

4. gene.com gene.com/media/press-releases/15065/2025-05-31/new-data-show-genentechs-itovebi-signifi

Genentech: Press Releases | Saturday, May 31, 2025 The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative ...

5. roche.com roche.com/media/releases/med-cor-2024-10-31

New England Journal of Medicine publishes landmark ... Results showed the Itovebi-based regimen reduced the risk of disease worsening or death (progression-free survival [PFS]) by 57% compared to palbociclib and ...

6. cancernetwork.com cancernetwork.com/view/inavolisib-based-therapy-boosts-progression-free-survival-in-breast-cancer

Inavolisib-Based Therapy Boosts Progression-Free ... In the safety analysis group, 98.8% of patients in the inavolisib group and 100.0% in the placebo group experienced at least 1 AE. AEs led to ...

7. gene.com gene.com/media/press-releases/15042/2024-10-30/new-england-journal-of-medicine-publishe

Genentech: Press Releases | Wednesday, Oct 30, 2024 Results showed the Itovebi-based regimen reduced the risk of disease worsening or death (progression-free survival [PFS]) by 57% compared to ...