癌研連線CancerLink
Active, not recruiting NCT06333951

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

Non-Small Cell Lung CancerPhase 1Stage IIIStage IVKRASPD-L1

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

Conditions: Thoracic Tumors, Non-small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

  • Subprotocol A, B, and C
  • 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.
  • Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.
  • Arm A (Anvumetostat + carboplatin + paclitaxel + pembrolizumab):
  • \- Predominantly squamous histology.
  • Arm B (Anvumetostat + carboplatin + pemetrexed + pembrolizumab):
  • \- Predominantly non-squamous histology.
  • Arm C (Anvumetostat + pembrolizumab):
  • \- PD-L1 positive.
  • Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.
  • Subprotocol C
  • Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
  • Brain lesion meeting RANO-BM criteria for measurable disease.

Exclusion Criteria

  • Subprotocol A, B, and C
  • 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.
  • Subprotocol A
  • \- Autoimmune disease or immunodeficiency disease as defined in the protocol'

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.