A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Parts 1 and 2: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) — 28 days
- Parts 1 and 2: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) — Up to approximately 3 years
Adverse events (AEs) are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs. Serious AEs (SAEs) are defined as any event that meets at least 1 of the following serious criteria: * Results in death (fatal) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event - Part 3: Objective Response Rate (ORR) — Up to approximately 3 years
Trial sites (75)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Japan
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 Japan