A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of Anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 22, 2026 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Amgen
- Interventions being studied
- Drug: Anvumetostat; Drug: IDE397
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Evidence of homozygous loss of MTAP (null) and/or MTAP deletion. 2. Presence of advanced/metastatic solid tumor not amenable to curative treatment 1. Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists 2. Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy. 3. Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product 4. Disease measurable as defined by RECIST v1.1 5. Adequate organ function as defined in the protocol. 6. Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.
1. Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor. 2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease. 3. Cardiovascular and pulmonary
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of Hope National Medical CenterDuarte, California
- Sarah Cannon Research InstituteDenver, Colorado
- Community Health Network MD Anderson Cancer Center - NorthIndianapolis, Indiana
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Health Partners Cancer Center at Regions HospitalSaint Paul, Minnesota
- Astera Cancer CareEast Brunswick, New Jersey
- New York University Grossman School of Medicine and New York University Langone HospitalsNew York, New York
- Columbia University Irving Medical CenterNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Duke UniversityDurham, North Carolina
- Prisma Health UpstateGreenville, South Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 22, 2026. Always confirm current availability with the study team.