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ACTIVE NOT RECRUITING

NCT05094336

PHASE1/PHASE2

A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of Anvumetostat alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the efficacy of Anvumetostat in adult participants with metastatic or locally advanced MTAP-null solid tumors.

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

329

Start Date

2022-02-01

Completion Date

2028-05-29

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Advanced MTAP-null Solid Tumors

Interventions

DRUG

Anvumetostat

Anvumetostat: Orally via tablet

DRUG

Docetaxel

Docetaxel: Intravenous infusion

DRUG

Comparator Anvumetostat Test Tablet

Comparator Anvumetostat test tablet: Orally via tablet. Only participants in the DSPS group of the Part 1a, Phase 1: Anvumetostat Monotherapy Dose Exploration, and Part 1j, Phase 1 arms will receive comparator Anvumetostat test tablet.

Inclusion Criteria: * Participant has provided informed consent/assent before initiation of any study specific activities/procedures. * Age ≥ 18 years. * Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) (Parts 1a, 1j, 1k, and 2a only) and/or methylthioadenosine phosphorylase (MTAP) (null) in the tumor tissue or blood (Parts 1a to 1k, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1k, Parts 2a and 2b). * Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation. * Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product. * Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Note: except participants enrolling to Part 1m. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Adequate hematopoietic function per local laboratory * Adequate renal function per local laboratory * Adequate glucose control per local laboratory (Part 1 only) * Adequate liver function per local laboratory * Adequate coagulation parameters * Adequate pulmonary function * Adequate cardiac function * Minimum life expectancy of 12 weeks as per investigator judgement. * Archived tumor tissue (formalin-fixed, paraffin-embedded \[FFPE\] sample collected within 5 years) or an archival block must be available. * For Part 1f (MTAP-null or lost MTAP expression HNSCC): Must be willing to undergo tumor biopsy. * For Part 1a: Must be willing to undergo tumor biopsy, before start of treatment (archival sample acceptable if obtained with 6 months of enrollment and subject has not received any other treatment since sample was obtained) and while on treatment. * For DSPS study (Part 1j): Must be willing to participate in DSPS substudy (US sites only). Food Effect Substudy (Part 1k): Specific Inclusion Criteria * Subject able and willing to eat a standardized high-fat, high-caloric meal * Subject able and willing to fast for ≥ 6 hours Specific Inclusion Criteria for subjects with glioma (Part 1m only) \- Disease measurable as defined per Modified Response Assessment in Neuro-Oncology Criteria 2.0 (mRANO 2.0) Exclusion Criteria: * Spinal cord compression or untreated brain metastases or leptomeningeal disease. * History of other malignancy within the past 2 years * Any evidence of current interstitial lung disease * Active infection * Evidence of active severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection. * History of arterial thrombosis * Myocardial infarction and/or symptomatic congestive heart failure. * Gastrointestinal tract disease * History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess * History of solid organ transplant. * Diagnosis of Congenital Short QT Syndrome. * Major surgery * Anti-tumor therapy within 28 days of study day 1. * Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor. * Prior treatment with docetaxel (Part 2 only) * Prior irradiation to 25% of the bone marrow. * Therapeutic or palliative radiation therapy within 2 weeks of study day 1. * Live vaccine therapy within 4 weeks before study drug administration. * Use of therapeutic anti-coagulation for treatment of active thromboembolic events. * Use of prescription medications that are known strong inducers of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1 * Unresolved toxicity from prior anti-cancer therapy * Currently receiving treatment in another investigational device or drug study. * Known positive test for Human Immunodeficiency Virus (HIV). * Positive hepatitis B surface antigen * positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR) * Female participants of childbearing potential unwilling to use protocol specified method of contraception

Locations (75)

City of Hope National Medical Center

Duarte, California, United States

California Research Institute

Glendale, California, United States

Fomat Medical Research

Oxnard, California, United States

University of California at SF

San Francisco, California, United States

D and H Cancer Research Center

Margate, Florida, United States

Boca Raton Clinical Research Medical Center Inc

Tamarac, Florida, United States

Goshen Health Systems

Goshen, Indiana, United States

Indiana University

Indianapolis, Indiana, United States

Community Health Network MD Anderson Cancer Center - North

Indianapolis, Indiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

American Oncology Partners, PA

Bethesda, Maryland, United States

Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Northwell Health Monter Cancer Center

Lake Success, New York, United States

New York University Grossman School of Medicine and New York University Langone Hospitals

New York, New York, United States

Duke University

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

Sarah Cannon Research Institute

Dallas, Texas, United States

Center for Oncology and Blood Disorders

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Lumi Research

Kingwood, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Virginia Cancer Specialists PC

Fairfax, Virginia, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Epworth Healthcare

East Melbourne, Victoria, Australia

Peter MacCallum Cancer Centre

Parkville, Victoria, Australia

Medizinische Universitaet Graz

Graz, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Cross Cancer Institute

Edmonton, Alberta, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Centre Georges Francois Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Hopitaux Universitaires Pitie Salpetriere - Charles Foix

Paris, France

Gustave Roussy

Villejuif, France

Universitaetsklinikum Halle - Saale

Halle, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

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

Istituto Oncologico della Svizzera Italiana

Bellinzona, Switzerland

Inselspital Bern

Bern, Switzerland

Hopitaux Universitaires de Geneve

Geneva, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Universitaetsspital Zuerich

Zurich, Switzerland

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan District, Taiwan

Sarah Cannon Research Institute UK

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

Clinical Research Directory

A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (75)