A Study of AMG 193 in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
NCT ID: NCT05094336
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
649 participants
INTERVENTIONAL
2022-02-01
2028-06-01
Brief Summary
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The primary objective of Part 3 of this study is to evaluate the efficacy of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration
Participants with MTAP-null solid tumors will receive escalating doses of AMG 193 to estimate the MTD and/or the RP2D.
AMG 193
AMG 193: Orally via tablet
Part 1c, Phase 1: AMG 193 Monotherapy Dose Expansion
Participants will receive the identified MTD/RP2D of AMG 193 in the following cohort: MTAP-null NSCLC.
AMG 193
AMG 193: Orally via tablet
Part 2a, Phase 1: AMG 193 Dose Exploration + Docetaxel
Participants with MTAP-null NSCLC will receive escalating doses of AMG 193 + a fixed dose of docetaxel to estimate the MTD/RP2D of the combination.
AMG 193
AMG 193: Orally via tablet
Docetaxel
Docetaxel: Intravenous infusion
Part 2b, Phase 1: AMG 193 + Docetaxel Dose Expansion
Participants with MTAP-null NSCLC will receive the identified MTD/RP2D of AMG 193 + docetaxel.
AMG 193
AMG 193: Orally via tablet
Docetaxel
Docetaxel: Intravenous infusion
Part 3: AMG 193 Phase 2
Participants with MTAP-null solid tumors will receive AMG 193.
AMG 193
AMG 193: Orally via tablet
Part 1e, Phase 1: AMG 193 Monotherapy Dose Expansion
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null BTC.
AMG 193
AMG 193: Orally via tablet
Part 1f, Phase 1: AMG 193 Monotherapy Dose Expansion
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort:
MTAP-null head and neck squamous cell carcinoma (HNSCC).
AMG 193
AMG 193: Orally via tablet
Part 1g, Phase 1: AMG 193 Monotherapy Dose Expansion
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort:
MTAP-null pancreatic adenocarcinoma.
AMG 193
AMG 193: Orally via tablet
Part 1h, Phase 1: AMG 193 Monotherapy Dose Expansion
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null or lost MTAP expression solid tumors (other than lymphoma or primary brain tumor).
AMG 193
AMG 193: Orally via tablet
Part 1i, Phase 1: AMG 193 Dose Optimization
Participants will receive a randomized dose optimization evaluation of AMG 193.
AMG 193
AMG 193: Orally via tablet
Part 1j, Phase 1: AMG 193 DSPS Substudy (US Sites Only)
Participants will receive doses of AMG 193 and comparator AMG 193 test tables at different times in a fasted state.
AMG 193
AMG 193: Orally via tablet
Comparator AMG 193 Test Tablet
Comparator AMG 193 test tablet: Orally via tablet. Only participants in the DSPS group of the Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration, and Part 1j, Phase 1 arms will receive comparator AMG 193 test tablet.
Part 1k, Phase 1: AMG 193 Food Effect Substudy (US Sites Only)
Participants will receive AMG 193 once on a fasted state and once after eating a standardized high-fat, high calorie meal.
AMG 193
AMG 193: Orally via tablet
Part 1l, Phase 1: AMG 193 Monotherapy Dose Expansion
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null esophageal/gastric cancer.
AMG 193
AMG 193: Orally via tablet
Part 1m, Phase 1: AMG 193 Monotherapy Dose Expansion
Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null glioma.
AMG 193
AMG 193: Orally via tablet
Interventions
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AMG 193
AMG 193: Orally via tablet
Docetaxel
Docetaxel: Intravenous infusion
Comparator AMG 193 Test Tablet
Comparator AMG 193 test tablet: Orally via tablet. Only participants in the DSPS group of the Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration, and Part 1j, Phase 1 arms will receive comparator AMG 193 test tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
* Subject able and willing to eat a standardized high-fat, high-caloric meal
* Subject able and willing to fast for ≥ 6 hours
\- Disease measurable as defined per Modified Response Assessment in Neuro-Oncology Criteria 2.0 (mRANO 2.0)
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-504363-17
Identifier Type: OTHER
Identifier Source: secondary_id
20210023
Identifier Type: -
Identifier Source: org_study_id