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NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Amgen
~49 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:AnvumetostatCarboplatinPaclitaxelPembrolizumabPemetrexedSotorasib

At a glance

Recruiting sites
0 of 83 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Dose Limiting Toxicities (DLT)
Measured over Up to approximately 21 days
+2 more outcomes measured

Conditions

Thoracic Tumors
Non-small Cell Lung Cancer

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Lung Non-Small Cell CarcinomaThoracic NeoplasmGTPase KRasMTAP GeneProgrammed Cell Death 1 Ligand 1

Where it's being run

83 sites across 46 states
California6
Poland5
New York4
Texas4
France4
Italy4
Germany3
Greece3

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before Anvumetostat dosing.
Homozygous MTAP-deletion
Able to swallow and retain PO administered study treatment.
Disease measurable as defined by RECIST v1.1.
Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
Brain lesion meeting RANO-BM criteria for measurable disease.

Exclusion

Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
History of solid organ transplant.
Major surgery within 28 days of first dose of Anvumetostat.
Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
Radiation therapy within 28 days of first dose.

What this trial measures

  • Number of Participants Experiencing Dose Limiting Toxicities (DLT)Up to approximately 21 days
  • Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)Up to approximately 3 years

    TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

  • Number of Participants Experiencing Serious Adverse Events (SAE)Up to approximately 3 years

    An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.