MesotheliomaPhase 2NCT06654050
Alrizomadlin (APG-115) in Subjects With BAP1 Cancer Syndrome and Early-Stage Mesothelioma
A Phase 2 study testing alrizomadlin in people with Mesothelioma and Malignant Mesothelioma (MM), run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Mesothelioma, Malignant Mesothelioma (MM), Early-stage Mesothelioma
- What is being tested?
- alrizomadlin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to 16 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of germline BRCA1-Associated Protein-1 (BAP1) mutations.
- Histologically confirmed by NCI Laboratory of Pathology (LP) subclinical/early-stage mesotheliomas.
- Participants with other early-stage BAP1-associated malignancies in addition to subclinical, early-stage mesotheliomas are eligible for the study.
- The extent of the disease (Tx by clinical staging criteria) must be insufficient to warrant approved front-line standard of care (SOC) therapies (surgery, chemotherapy, immunotherapy). Participants with clinical T1 tumors are eligible for protocol if they have been offered and have refused front-line SOC therapy.
- Age >=18 years.
- Evaluable disease as confirmed by minimally invasive (videoscopic) assessment (thoracoscopy and/or laparoscopy with biopsy).
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- Willingness to undergo pre- and post-treatment minimally invasive thoracoscopy and/orlaparoscopy to assess treatment response.
- Willingness to co-enroll on 20-C-0106 (Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients with BAP1 Tumor Predisposition Syndrome) and 06-C-0014 (Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic) to enable collection/processing of tumor, blood and normal pleura).
- ECOG performance status <=1
- Adequate pulmonary reserve evidenced by forced expiratory volume (FEV)1 and diffusing capacity of the lungs for carbon monoxide (DLCO) >=35% predicted on screening pulmonary function testing (PFTs).
- Oxygen saturation >=92% on room air by pulse oximetry at screening.
- Adequate renal, hepatic, and hematopoietic function as defined below:
- leukocytes >= 3,000/micro L
- absolute neutrophil count >=1,500/micro L (without transfusion or cytokine support within 2 months prior to study treatment initiation)
- absolute lymphocyte count > 800/micro L
- platelets >= 100,000/micro L and < 1,200,000/micro L
- prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN)
- total bilirubin < 1.5 X institutional ULN OR direct bilirubin <= 1 ULN for participants with total bilirubin >= 1.5 ULN serum albumin >=2.0 mg/dL
- aspartate aminotransferase (AST) <=2.5 X institutional ULN
- alanine aminotransferase (ALT) <= 2.5 X institutional ULN
- estimated glomerular filtration rate (eGFR) >=60 mL/min/1.73 m2.
- Individuals of child-bearing potential (IOCBP) and those able to father a child must agree to use an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization) from the study entry and up to 3 months after the last dose of APG-115.
- Nursing (i.e., breastfeeding/chest feeding) participants must be willing to discontinue nursing from study treatment initiation through 4 weeks after the last dose of the study drug.
- The ability of a participant to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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
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- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase II Study of Alrizomadlin (APG-115) in Subjects With BAP1 Cancer Syndrome and Early-Stage Mesothelioma
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.
Read more
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.
Read the detailed description
Background:
- Mutations involving BRCA1-Associated Protein-1 (BAP1), a nuclear deubiquitinase involved in epigenetic regulation of gene expression, DNA repair, and cellular energetics, have emerged as one of the most common somatic mutations in malignant mesotheliomas.
- Germline mutations involving BAP1 predispose individuals to mesotheliomas and a variety of other malignancies including melanomas, as well as lung, renal, gastric, breast, and hepatobiliary carcinomas.
- The cancer penetrance of germline BAP1 mutations is nearly 100%, and most patients develop multiple synchronous or metachronous neoplasms.
- Mesotheliomas are the most common malignancies diagnosed in subjects with BAP1 Cancer Syndrome (BCS), previously known as BAP1 Cancer Predisposition Syndrome (CPDS).
- Although clinically evident mesotheliomas arising in the context of germline BAP1 mutations tend to be more indolent than more common, sporadic mesotheliomas, the natural history of early-stage mesotheliomas in subjects with BAP1 BCS is unknown.
- Presently there are no established guidelines for the treatment of subclinical malignancies in subjects with BAP1 BCS.
- Ubiquitin-like with plant homeodomain and ring finger domains 1 (UHRF1) is a master regulator of DNA methylation and genome integrity in normal cells.
- Up-regulation of UHRF1 during malignant transformation induces widespread epigenomic perturbations including global DNA hypomethylation and paradoxical site-specific DNA hypermethylation of tumor suppressor genes.
- Dysregulation of DNA methylation induces genomic instability and enhances growth as well as invasion and metastatic potential of cancer cells and promotes an immunosuppressive tumor micro-environment (TME).
- Up-regulation of UHRF1 is an early event during mesothelioma development, and UHRF1 over-expression is associated with markedly decreased survival in mesothelioma patients.
- Biochemical inhibition of UHRF1 expression inhibits the growth of mesothelioma cells invitro and in-vivo.
- UHRF1 expression can be repressed by mdm2 inhibitors which activate p53 signaling. In addition to direct effects on cancer cells, mdm2 inhibitors can reprogram TMEs thereby promoting more effective antitumor immune responses.
- APG-115 is an oral, highly potent, mdm2 inhibitor that is in clinical development.
- Conceivably APG-115 therapy can arrest or delay the progression of subclinical/early stage mesotheliomas in subjects with BAP1 BCS.
Objective:
-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
Eligibility:
- History of germline BRCA1-Associated Protein-1 (BAP1) mutations.
- Histologically confirmed subclinical/early-stage mesotheliomas.
- The extent of the disease must be insufficient to warrant approved front-line standard-of care therapies (surgery, chemotherapy, immunotherapy).
- Age >= 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <=1.
- Willingness to undergo pre- and post-treatment, minimally invasive thoracoscopy, and/or laparoscopy to assess treatment response.
- Adequate cardiac, renal, hepatic, and hematopoietic function.
Design:
- Participants with subclinical, early-stage mesotheliomas will undergo baseline imaging studies followed by minimally invasive thoracoscopy and/or laparoscopy to document the extent of the disease and obtain biopsies for pharmacodynamic (PD) endpoints.
- Participants will start oral APG-115 at a fixed dose and schedule (150 mg on Days 1, 3, 5,7, 9, 11, and 13 of a 21-day cycle) and will continue this regimen for 8 cycles.
- After eight cycles, participants will undergo repeat imaging and minimally invasive thoracoscopy and/or laparoscopy to determine treatment response and obtain tissue for response endpoints.
- Participants with stable disease or disease regression will be offered an additional 8 cycles of APG-115 treatment.
- Approximately 13 participants will be administered investigational therapy on this protocol.
- Conditions
- Mesothelioma, Malignant Mesothelioma (MM), Early-stage Mesothelioma, Subclinical Mesothelioma, BRCA1-Associated Protein-1 (BAP1) Mutations, Early-stage BAP1-associated Malignancies
- Being tested
- alrizomadlin
- Keywords
- BRCA1-Associated Protein-1 (BAP1), BAP1 Cancer Syndrome (BCS), BAP1 Cancer Predisposition Syndrome (CPDS), ring finger domains 1 (UHRF1), mdm2 inhibitors (MDM2 inhibitors), p53, DNA methyltransferases 1 (DNMT1), peripheral immune subsets
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alrizomadlinDrug
Alrizomadlin (APG-115) oral tablets (150 mg) taken every other day on Days 1, 3, 5, 7, 9, 11, and 13 of every cycle (1 cycle=21 days) for 8 cycles (i.e., Course 1). Individuals with stable or responding disease may receive an additional 8 cycles (i.e., Course 2). Maximum (total) of 2 treatment courses.
| Study group | Role | What they receive |
|---|---|---|
| 1/ Arm 1 | Experimental | APG-115 Receives: Drug: alrizomadlin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Fraction of evaluable participants who are able to have stabilization or improvement of disease will be reported along with a 95% confidence interval. Response rates will be calculated as the percent of participants whose best response is a stabilization or improvement of disease.
Measured: baseline, and after every 8 treatment cycles (Course 1 and Course 2)
Secondary outcomes (1)
To evaluate the safety of APG-115
Safety and tolerability of the agents will be evaluated by reviewing the AEs and reporting events as required. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and probable association with the study regimen.
Measured: starts at initiation of study drug, assessed Days 1 of every cycle, and through 30 days (safety visit) after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start16 Mar 2026
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Why it stopped: The study is being withdrawn due to the CRADA with the company not being finalized
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David S Schrump, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654050
- Sponsor's protocol ID
- 10001605
- Other IDs
- 001605-C
- Status last verified
- Mar 2026
- First submitted
- 22 Oct 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Alrizomadlin (APG-115) in Subjects With BAP1 Cancer Syndrome and Early-Stage Mesothelioma
- ClinicalTrials.gov ID
- NCT06654050
- Acronym / sponsor ID
- 10001605
- Conditions
- Mesothelioma, Malignant Mesothelioma (MM), Early-stage Mesothelioma, Subclinical Mesothelioma, BRCA1-Associated Protein-1 (BAP1) Mutations, Early-stage BAP1-associated Malignancies
- Keywords
- BRCA1-Associated Protein-1 (BAP1), BAP1 Cancer Syndrome (BCS), BAP1 Cancer Predisposition Syndrome (CPDS), ring finger domains 1 (UHRF1), mdm2 inhibitors (MDM2 inhibitors), p53, DNA methyltransferases 1 (DNMT1), peripheral immune subsets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is being withdrawn due to the CRADA with the company not being finalized
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Mutations involving BRCA1-Associated Protein-1 (BAP1), a nuclear deubiquitinase involved in epigenetic regulation of gene expression, DNA repair, and cellular energetics, have emerged as one of the most common somatic mutations in malignant mesotheliomas.
- Germline mutations involving BAP1 predispose individuals to mesotheliomas and a variety of other malignancies including melanomas, as well as lung, renal, gastric, breast, and hepatobiliary carcinomas.
- The cancer penetrance of germline BAP1 mutations is nearly 100%, and most patients develop multiple synchronous or metachronous neoplasms.
- Mesotheliomas are the most common malignancies diagnosed in subjects with BAP1 Cancer Syndrome (BCS), previously known as BAP1 Cancer Predisposition Syndrome (CPDS).
- Although clinically evident mesotheliomas arising in the context of germline BAP1 mutations tend to be more indolent than more common, sporadic mesotheliomas, the natural history of early-stage mesotheliomas in subjects with BAP1 BCS is unknown.
- Presently there are no established guidelines for the treatment of subclinical malignancies in subjects with BAP1 BCS.
- Ubiquitin-like with plant homeodomain and ring finger domains 1 (UHRF1) is a master regulator of DNA methylation and genome integrity in normal cells.
- Up-regulation of UHRF1 during malignant transformation induces widespread epigenomic perturbations including global DNA hypomethylation and paradoxical site-specific DNA hypermethylation of tumor suppressor genes.
- Dysregulation of DNA methylation induces genomic instability and enhances growth as well as invasion and metastatic potential of cancer cells and promotes an immunosuppressive tumor micro-environment (TME).
- Up-regulation of UHRF1 is an early event during mesothelioma development, and UHRF1 over-expression is associated with markedly decreased survival in mesothelioma patients.
- Biochemical inhibition of UHRF1 expression inhibits the growth of mesothelioma cells invitro and in-vivo.
- UHRF1 expression can be repressed by mdm2 inhibitors which activate p53 signaling. In addition to direct effects on cancer cells, mdm2 inhibitors can reprogram TMEs thereby promoting more effective antitumor immune responses.
- APG-115 is an oral, highly potent, mdm2 inhibitor that is in clinical development.
- Conceivably APG-115 therapy can arrest or delay the progression of subclinical/early stage mesotheliomas in subjects with BAP1 BCS.
Objective:
-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
Eligibility:
- History of germline BRCA1-Associated Protein-1 (BAP1) mutations.
- Histologically confirmed subclinical/early-stage mesotheliomas.
- The extent of the disease must be insufficient to warrant approved front-line standard-of care therapies (surgery, chemotherapy, immunotherapy).
- Age >= 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <=1.
- Willingness to undergo pre- and post-treatment, minimally invasive thoracoscopy, and/or laparoscopy to assess treatment response.
- Adequate cardiac, renal, hepatic, and hematopoietic function.
Design:
- Participants with subclinical, early-stage mesotheliomas will undergo baseline imaging studies followed by minimally invasive thoracoscopy and/or laparoscopy to document the extent of the disease and obtain biopsies for pharmacodynamic (PD) endpoints.
- Participants will start oral APG-115 at a fixed dose and schedule (150 mg on Days 1, 3, 5,7, 9, 11, and 13 of a 21-day cycle) and will continue this regimen for 8 cycles.
- After eight cycles, participants will undergo repeat imaging and minimally invasive thoracoscopy and/or laparoscopy to determine treatment response and obtain tissue for response endpoints.
- Participants with stable disease or disease regression will be offered an additional 8 cycles of APG-115 treatment.
- Approximately 13 participants will be administered investigational therapy on this protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/ Arm 1 | Experimental | Drug: alrizomadlinAPG-115 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- History of germline BRCA1-Associated Protein-1 (BAP1) mutations.
- Histologically confirmed by NCI Laboratory of Pathology (LP) subclinical/early-stage mesotheliomas.
- Participants with other early-stage BAP1-associated malignancies in addition to subclinical, early-stage mesotheliomas are eligible for the study.
- The extent of the disease (Tx by clinical staging criteria) must be insufficient to warrant approved front-line standard of care (SOC) therapies (surgery, chemotherapy, immunotherapy). Participants with clinical T1 tumors are eligible for protocol if they have been offered and have refused front-line SOC therapy.
- Age >=18 years.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alrizomadlinAlrizomadlin (APG-115) oral tablets (150 mg) taken every other day on Days 1, 3, 5, 7, 9, 11, and 13 of every cycle (1 cycle=21 days) for 8 cycles (i.e., Course 1). Individuals with stable or responding disease may receive an additional 8 cycles (i.e., Course 2). Maximum (total) of 2 treatment courses. | Drug | 1/ Arm 1 |
Primary outcome
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
Time frame: baseline, and after every 8 treatment cycles (Course 1 and Course 2)
Fraction of evaluable participants who are able to have stabilization or improvement of disease will be reported along with a 95% confidence interval. Response rates will be calculated as the percent of participants whose best response is a stabilization or improvement of disease.
1 secondary outcome
To evaluate the safety of APG-115
Time frame: starts at initiation of study drug, assessed Days 1 of every cycle, and through 30 days (safety visit) after the last study drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Schrump, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alrizomadlin in people with Mesothelioma and Malignant Mesothelioma (MM), run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: baseline, and after every 8 treatment cycles (Course 1 and Course 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.