🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05094336
Active, not recruiting Phase 1/2

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

NCT05094336 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 1/2
Started
2022-02-01
Last updated
2026-05-28

Condition(s) studied

Advanced MTAP-null Solid Tumors

Investigational drug(s) / intervention(s)

AnvumetostatDocetaxelComparator Anvumetostat Test Tablet

Anvumetostat: Anvumetostat: Orally via tablet

Docetaxel: Docetaxel: Intravenous infusion

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (75)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California
California Research Institute Glendale California
Fomat Medical Research Oxnard California
University of California at SF San Francisco California
D and H Cancer Research Center Margate Florida
Boca Raton Clinical Research Medical Center Inc Tamarac Florida
Goshen Health Systems Goshen Indiana
Indiana University Indianapolis Indiana
Community Health Network MD Anderson Cancer Center - North Indianapolis Indiana
University of Maryland Medical Center Baltimore Maryland
American Oncology Partners, PA Bethesda Maryland
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion) Detroit Michigan
Washington University St Louis Missouri
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
Roswell Park Cancer Institute Buffalo New York
Northwell Health Monter Cancer Center Lake Success New York
New York University Grossman School of Medicine and New York University Langone Hospitals New York New York
Duke University Durham North Carolina
University Hospitals Cleveland Medical Center Cleveland Ohio
University of Pennsylvania Philadelphia Pennsylvania
Thomas Jefferson University Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Sanford Oncology Clinic and Pharmacy Sioux Falls South Dakota
Sarah Cannon Research Institute Dallas Texas
Center for Oncology and Blood Disorders Houston Texas
University of Texas MD Anderson Cancer Center Houston Texas
Lumi Research Kingwood Texas
South Texas Accelerated Research Therapeutics San Antonio Texas
University of Virginia Cancer Center Charlottesville Virginia
Virginia Cancer Specialists PC Fairfax Virginia
Chris OBrien Lifehouse Camperdown New South Wales
Epworth Healthcare East Melbourne Victoria
Peter MacCallum Cancer Centre Parkville Victoria
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

+ 35 more sites — see the full list on the official registry below.

More Amgen trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05094336 on ClinicalTrials.gov ↗ ← All trials in the USA