CompletedPhase 1 / Phase 2NCT05975073

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).

Checked against the public recordLast updated Apr 22, 2026 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations27
SponsorAmgen
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Amgen
Interventions being studied
Drug: Anvumetostat; Drug: IDE397
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria 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. Exclusion Criteria 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 exclusion criteria as defined in the protocol. 4. 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) 5. History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry. 6. Prior irradiation to \> 25% of the bone marrow 7. Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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