Alrizomadlin (APG-115) in Subjects With BAP1 Cancer Syndrome and Early-Stage Mesothelioma

Withdrawn before enrolling · Phase 2

Conditions studied: Mesothelioma, Malignant Mesothelioma (MM), Early-stage Mesothelioma, Subclinical Mesothelioma, BRCA1-Associated Protein-1 (BAP1) Mutations, Early-stage BAP1-associated Malignancies

In brief

Background: Mesothelioma is a rare cancer typically caused by exposure to asbestos and related fibers. Most people with mesothelioma survive less than 5 years after diagnosis. About 3000 people in the United States die from this disease each year. People with inherited mutations in the BAP1 gene \[called BAP1 Cancer Syndrome (BCS)\] are more likely to develop mesothelioma and other cancers such as melanomas and renal cell carcinomas without asbestos exposure. Almost all people with BCS develop multiple cancers, of which mesothelioma is the most commonly observed. Objective: To test a study drug (APG-115) in participants with BAP1 Cancer Syndrome (BCS) and early-stage mesothelioma. Eligibility: People aged 18 years and older with germline BAP1 mutations and early-stage mesothelioma that does not yet need standard treatment are eligible for protocol enrollment. Participants will be required to also enroll in NIH protocols 20-C-0106 and 06-C-0014 which allow for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies. Design: Participants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. A procedure using a flexible tube with a camera and light will be inserted into the participant s chest and abdomen through a small cut to look at the tumors and to collect a tissue sample (biopsy). APG-115 capsules are taken by mouth. Participants will take the drug at home every other day for the first 13 days of the 21-day treatment cycles. On the first day of each cycle, researchers will call or email participants to check on their health. Participants will have blood tests 2 times a week during the first 2 cycles; after that, the blood tests will be weekly. These blood tests can be done at a local medical facility or at the NIH Clinical Center. Participants may continue treatment for up to 16 cycles. Imaging scans, biopsy, and other tests will be repeated after 8 and 16 cycles.

Key facts

Study ID: NCT06654050
Run by: National Cancer Institute (NCI)
People needed: 0
Starts: 2026-03-16
Expected to finish: 2026-03-16
Last updated by the study team: 2026-03-17

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Participants with any cancers requiring front-line standard of care treatment.
Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke within 6 months prior to study treatment initiation, myocardial infarction within 6 months prior to study treatment initiation unless revascularized post infarction and cleared by cardiology consultants.
Unstable angina, congestive heart failure (New York Heart Association Classification Class >= II (https://manual.jointcommission.org/releases/TJC2016A/DataElem0439.html#:\~:text=Class%20II%20%2D%20Mild%20symptoms%20(mild,Class%20IV%20%2D%20Severe%20limitations.), serious cardiac arrhythmia, clinically significant bleeding or clinically significant pulmonary embolism at screening.
QTcF interval > than the 470 ms.
Therapeutic anticoagulation within 2 weeks prior to study treatment initiation. Note: Oral agents and Lovenox, etc., are monitored by factor 10 levels, not PT or partial thromboplastin time (PTT).
Participants receiving inhibitors or inducers of CYP3A4/3A5 as well as participants receiving P-glycoprotein inhibitors within 2 weeks prior to study treatment initiation treatment initiation
(https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm#table2-2,table3-3,table5-2,
Positive Hepatitis A (HAV) serological test, positive Hepatitis B (HBV) serological test, or positive Hepatitis C (HCV) serological test with detected quantitative HCV RNA at screening.
Participants seropositive for human immunodeficiency virus (HIV) infection.
Active infections requiring systemic therapy.
Immunosuppressive medications within 4 weeks prior to study treatment initiation except non-systemic corticosteroids.
Positive beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in individuals of childbearing potential at screening.
Uncontrolled intercurrent illness evaluated by medical history and physical exam or situation that is not stable (e.g., recent hospitalization, Emergency Room visit or undergoing medication changes) that would potentially increase in risk of participant.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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