Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
Running, not enrolling · Phase 1
Conditions studied: Thoracic Tumors, Non-small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06333951
- Run by
- Amgen
- People needed
- 49
- Starts
- 2024-09-17
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Subprotocol A, B, and C
- Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
- 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'
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- City of Hope Orange County Lennar Foundation Cancer Center — Duarte, California, United States
- Translational Research in Oncology US Inc, Trio Central Pharmacy — Los Angeles, California, United States
- University of California Irvine — Orange, California, United States
- University of California Los Angeles — Santa Monica, California, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States
- HealthPartners Institute — Saint Paul, Minnesota, United States
- Saint Lukes Hospital of Kansas City — Kansas City, Missouri, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- New York University Grossman School of Medicine — New York, New York, United States
- Perlmutter Cancer Center at New York University Langone Hospital----Long Island — New York, New York, United States
- Upstate University Hospital — Syracuse, New York, United States
- Hightower Clinical — Oklahoma City, Oklahoma, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- University of Tennessee Medical Center Knoxville — Knoxville, Tennessee, United States
- United States Oncology Regulatory Affairs Corporate Office — Nashville, Tennessee, United States
- Texas Oncology - Dallas Fort Worth — Dallas, Texas, United States
- US Oncology Research Investigational Products Center — Dallas, Texas, United States
- Oncology Consultants Cancer Center — Houston, Texas, United States
- Texas Oncology Northeast Texas — Tyler, Texas, United States
- Virginia Cancer Specialists PC — Fairfax, Virginia, United States
- Comprehensive Blood and Cancer Center — Bakersfield, California, United States
Full record on ClinicalTrials.gov
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