Vepdegestrant for Liver Function Study

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Prohibited medications

Disqualifiers: Drug absorption issues, Hepatic dysfunction, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the body processes a new medicine called vepdegestrant, focusing on participants with varying liver function levels. It compares the medicine's effects in individuals with normal liver function to those with liver impairment. Participants will take a single oral dose and remain in a clinic for about 11 days. The study seeks females who cannot have children or males weighing over 110 pounds, with either healthy liver function or stable liver impairment. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new medicine.

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

A previous study found vepdegestrant to be generally safe. Most side effects were mild, with common issues including minor stomach problems. However, some patients experienced serious liver-related side effects, such as increased liver enzyme levels, indicating potential liver damage. Despite these concerns, vepdegestrant is already approved for certain types of breast cancer, suggesting it is usually well-tolerated and considered safe for use in those cases. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for liver conditions, which often focus on managing symptoms and preventing further damage, Vepdegestrant is being explored for its potential to directly improve liver function. Researchers are excited about Vepdegestrant because it may offer a new mechanism of action that targets specific pathways involved in liver function. This could be particularly beneficial for patients with varying degrees of hepatic impairment, offering a more tailored approach to treatment. If successful, Vepdegestrant may provide a novel therapeutic option that enhances liver health more effectively than existing therapies.

What evidence suggests that vepdegestrant might be an effective treatment for liver function?

Studies have shown that vepdegestrant, a drug that breaks down estrogen receptors, can be effective for certain cancers. Specifically, in patients with advanced breast cancer, research indicates that vepdegestrant extended the time patients lived without their cancer worsening by about 2.9 months compared to fulvestrant. This provided patients with more time before cancer progression. Additionally, vepdegestrant helped maintain quality of life for longer and delayed symptom worsening. These findings suggest vepdegestrant could be an effective treatment, especially for cancers that rely on estrogen to grow. In this trial, researchers are studying vepdegestrant in different groups based on liver function to assess its effects on participants with varying degrees of hepatic impairment. ^{2 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

My BMI is between 17.5 and 38, and I weigh more than 110 pounds.

I am in good health based on recent medical exams and tests.

My liver function is moderately or severely impaired.

Exclusion Criteria

I have liver problems caused by a current liver disease, confirmed by medical tests.

I do not have any condition that affects how my body absorbs medicine.

I do not have any serious health conditions except mild, untreated seasonal allergies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of vepdegestrant

1 day

1 visit (in-person)

Observation

Participants are monitored for pharmacokinetics of vepdegestrant

11 days

Continuous stay at the clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vepdegestrant

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 1 Intervention

participants with severe hepatic impairment

Group II: Group 2 Experimental Treatment 1 Intervention

participants with moderate hepatic impairment

Group III: Group 1 Experimental Treatment 1 Intervention

participants with normal hepatic function

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Arvinas Estrogen Receptor, Inc.

Industry Sponsor

Trials

19

Recruited

2,400+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11396746/

Stability Evaluation and Pharmacokinetic Profiling of ... - PMC

The matrix effect, recovery, and process efficiency of vepdegestrant and IS in mouse and rat plasma were evaluated using LQC, MQC, and HQC, and ...

2.

nejm.org

nejm.org/doi/10.1056/NEJMoa2505725

Vepdegestrant, a PROTAC Estrogen Receptor Degrader, ...

Results. A total of 624 patients underwent randomization; 313 were assigned to receive vepdegestrant, and 311 to receive fulvestrant. Among the ...

3.

bpspubs.onlinelibrary.wiley.com

bpspubs.onlinelibrary.wiley.com/doi/10.1002/bcp.70198

Effect of vepdegestrant, a PROTAC oestrogen receptor ...

Most recently, vepdegestrant (200 mg QD) demonstrated significantly longer progression-free survival (the primary efficacy endpoint) than the ...

4.

ir.arvinas.com

ir.arvinas.com/news-releases/news-release-details/patient-reported-outcomes-veritac-2-clinical-trial-support/

Patient-Reported Outcomes from VERITAC-2 Clinical Trial ...

Data demonstrated that vepdegestrant maintained patients' quality of life for statistically significantly longer and delayed worsening of ...

5.

onclive.com

onclive.com/view/veritac-2-pro-data-support-potential-of-vepdegestrant-in-esr1-mutated-er-advanced-breast-cancer

VERITAC-2 PRO Data Support Potential of Vepdegestrant ...

Vepdegestrant maintained QOL and reduced risk of symptom deterioration vs fulvestrant in ESR1-mutated ER-positive, HER2-negative advanced ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11524203/

VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ER ...

VERITAC-2 is an open-label, randomized, global, multicenter, Phase III study comparing the efficacy and safety of vepdegestrant with fulvestrant in adults with ...

7.

ir.arvinas.com

ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-approval-veppanu-vepdegestrant-treatment/

Press Release Details

The Phase 3 VERITAC-2 clinical trial (NCT05654623) is a global, randomized, open-label trial evaluating the efficacy and safety of vepdegestrant ...

8.

chemistry-europe.onlinelibrary.wiley.com

chemistry-europe.onlinelibrary.wiley.com/doi/10.1002/cmdc.202501111

Insights Into Vepdegestrant (ARV‐471): The First‐in‐Class ...

Overall, the preclinical safety package indicates a favorable therapeutic index, with near-complete ERα degradation and robust antitumor ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06206837

NCT06206837 | A Study to Learn About Vepdegestrant ...

The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can ...