A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: MTAP-null Non-Small-Cell Lung Cancer, MTAP-null Solid Tumors

In brief

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).

Key facts

Study ID

NCT05975073

Run by

Amgen

People needed

53

Starts

2023-08-01

Expected to finish

2026-03-26

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
• Presence of advanced/metastatic solid tumor not amenable to curative treatment
• Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
• Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
• Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
• Disease measurable as defined by RECIST v1.1
• Adequate organ function as defined in the protocol.
• Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.

You may not qualify if…

• Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
• Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
• 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 bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
• Prior irradiation to > 25% of the bone marrow
• 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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Sarah Cannon Research Institute — Denver, Colorado, United States
• Community Health Network MD Anderson Cancer Center - North — Indianapolis, Indiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Health Partners Cancer Center at Regions Hospital — Saint Paul, Minnesota, United States
• Astera Cancer Care — East Brunswick, New Jersey, United States
• New York University Grossman School of Medicine and New York University Langone Hospitals — New York, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Prisma Health Upstate — Greenville, South Carolina, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Next Oncology — Irving, Texas, United States
• The Queen Elizabeth Hospital — Woodville South, South Australia, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Rigshospitalet — Copenhagen, Denmark
• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital Yonsei University Health System — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Hospital Universitari Vall d Hebron — Barcelona, Catalonia, Spain
• Hospital Universitario Ramon y Cajal — Madrid, Spain

Full record on ClinicalTrials.gov

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