Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be if
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'
Clareo Health | Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
