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MDM2 Inhibitor

Alrizomadlin for Mesothelioma

Phase 2

Waitlist Available

Led By David S Schrump, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of germline BRCA1-Associated Protein-1 (BAP1) mutations

Histologically confirmed by NCI Laboratory of Pathology (LP) subclinical/early-stage mesotheliomas

Must not have

Participants with any cancers requiring front-line standard of care treatment

Clinically significant cardiovascular/cerebrovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and after every 8 treatment cycles (course 1 and course 2)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how well a new drug, alrizomadlin (APG-115), works in treating early-stage mesotheliomas in people with a specific genetic condition called BR

Who is the study for?

This trial is for individuals with early-stage mesothelioma, a type of cancer that affects the lining of the lungs, and who have BAP1 Cancer Syndrome. Participants should carry specific genetic changes known as BAP1 mutations.

What is being tested?

The study is testing alrizomadlin (APG-115) to see if it can stabilize or improve mesothelioma in patients with BAP1 Cancer Syndrome. It's a phase II trial, which means they're looking at how well the drug works and checking its safety.

What are the potential side effects?

Specific side effects are not listed here, but generally, participants will be monitored for any toxicity related to APG-115 treatment. This could include typical drug-related adverse reactions such as nausea, fatigue, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a genetic mutation in the BAP1 gene.

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My early-stage mesothelioma has been confirmed by a pathology lab.

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My disease is not severe enough for standard treatments like surgery or chemotherapy.

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I am 18 years old or older.

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My disease was confirmed through a minimally invasive procedure.

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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need first-line standard treatment for my cancer.

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I have a serious heart or brain blood vessel condition.

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I have not been on blood thinners in the last 2 weeks.

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I am not taking medication that affects CYP3A4/3A5 or P-glycoprotein.

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I am currently being treated for an infection.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and after every 8 treatment cycles (course 1 and course 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, and after every 8 treatment cycles (course 1 and course 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and after every 8 treatment cycles (course 1 and course 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine stabilization or disease improvement rates in participants with early-stage mesotheliomas arising in the context of BAP1 Cancer Syndrome (BCS) following APG-115 treatment

Secondary study objectives

To evaluate the safety of APG-115