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ACTIVE NOT RECRUITING
NCT05975073
PHASE1/PHASE2

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2023-08-01

Completion Date

2026-04-01

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Anvumetostat

Administered PO

DRUG

IDE397

Administered PO

Locations (27)

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

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan