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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced MTAP-null Solid Tumors
• Intervention / Treatment: Drug: Docetaxel; Drug: Anvumetostat; Drug: Comparator Anvumetostat Test Tablet

• Study Type: Interventional
• Enrollment (Actual): 329
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris OBrien Lifehouse
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Epworth Healthcare
    • Parkville, Victoria, Australia, 3050
      • Peter MacCallum Cancer Centre
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitaet Graz
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg
• Belgium
  • Brussels, Belgium, 1200
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis - Campus Virga Jesse
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400044
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
    • Fuzhou, Fujian, China, 350028
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai Municipality, China, 200123
      • Shanghai East Hospital
• France
  • Dijon, France, 21000
    • Centre Georges François Leclerc
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Paris, France, 75013
    • Hopitaux Universitaires Pitie Salpetriere - Charles Foix
  • Villejuif, France, 94805
    • Gustave Roussy
• Germany
  • Halle, Germany, 06120
    • Universitaetsklinikum Halle - Saale
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
  • Würzburg, Germany, 97078
    • Universitaetsklinikum Wuerzburg
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital, The University of Hong Kong
  • Shatin, New Territories, Hong Kong
    • Prince of Wales Hospital, Chinese University of Hong Kong
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
• South Korea
  • Seongnam-si, Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Istituto Oncologico della Svizzera Italiana
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Geneva, Switzerland, 1211
    • Hopitaux universitaires de Geneve
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital Sankt Gallen
  • Zurich, Switzerland, 8091
    • Universitaetsspital Zuerich
• Taiwan
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
• United Kingdom
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute UK
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Glendale, California, United States, 91204
      • California Research Institute
    • Oxnard, California, United States, 93030
      • Fomat Medical Research
    • San Francisco, California, United States, 94158
      • University of California at SF
  • Florida
    • Margate, Florida, United States, 33063
      • D and H Cancer Research Center
    • Tamarac, Florida, United States, 33321
      • Boca Raton Clinical Research Medical Center Inc
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Health Systems
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network MD Anderson Cancer Center - North
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Bethesda, Maryland, United States, 20817
      • American Oncology Partners, PA
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
  • New York
    • Buffalo, New York, United States, 32224
      • Roswell Park Cancer Institute
    • Lake Success, New York, United States, 11042
      • Northwell Health Monter Cancer Center
    • New York, New York, United States, 10016
      • New York University Grossman School of Medicine and New York University Langone Hospitals
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19106
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 54104
      • Sanford Oncology Clinic and Pharmacy
  • Texas
    • Dallas, Texas, United States, 75230
      • Sarah Cannon Research Institute
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Center for Oncology and Blood Disorders
    • Kingwood, Texas, United States, 77339
      • Lumi Research
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Cancer Center
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1a, Phase 1: Anvumetostat Monotherapy Dose Exploration; Participants with MTAP-null solid tumors will receive escalating doses of Anvumetostat to estimate the MTD and/or the RP2D.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1c, Phase 1: Anvumetostat Monotherapy Dose Expansion; Participants will receive the identified MTD/RP2D of Anvumetostat in the following cohort: MTAP-null NSCLC.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 2a, Phase 1: Anvumetostat Dose Exploration + Docetaxel; Participants with MTAP-null NSCLC will receive escalating doses of Anvumetostat + a fixed dose of docetaxel to estimate the MTD/RP2D of the combination.	Drug: Docetaxel; Docetaxel: Intravenous infusion; Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 2b, Phase 1: Anvumetostat + Docetaxel Dose Expansion; Participants with MTAP-null NSCLC will receive the identified MTD/RP2D of Anvumetostat + docetaxel.	Drug: Docetaxel; Docetaxel: Intravenous infusion; Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 3: Anvumetostat Phase 2; Participants with MTAP-null solid tumors will receive Anvumetostat.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1e, Phase 1: Anvumetostat Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null BTC.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1f, Phase 1: Anvumetostat Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null head and neck squamous cell carcinoma (HNSCC).	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1g, Phase 1: Anvumetostat Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null pancreatic adenocarcinoma.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1h, Phase 1: Anvumetostat Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null or lost MTAP expression solid tumors (other than lymphoma or primary brain tumor).	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1i, Phase 1: Anvumetostat Dose Optimization; Participants will receive a randomized dose optimization evaluation of Anvumetostat.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1j, Phase 1: Anvumetostat DSPS Substudy (US Sites Only); Participants will receive doses of Anvumetostat and comparator Anvumetostat test tables at different times in a fasted state.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193; 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.
Experimental: Part 1k, Phase 1: Anvumetostat Food Effect Substudy (US Sites Only); Participants will receive Anvumetostat once on a fasted state and once after eating a standardized high-fat, high calorie meal.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1l, Phase 1: Anvumetostat Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null esophageal/gastric cancer.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193
Experimental: Part 1m, Phase 1: Anvumetostat Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null glioma.	Drug: Anvumetostat; Anvumetostat: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; AMG 193

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Up to approximately 3 years
Part 3: Objective Response Rate (ORR)		Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2 Only: Maximal Plasma Concentration (Cmax) of Docetaxel		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Part 2 Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Docetaxel		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Part 2 Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Docetaxel		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Parts 1 and 2: ORR		Up to approximately 3 years
Parts 1, 2 and 3: Disease Control Rate (DCR)		Up to approximately 3 years
Parts 1, 2 and 3: Duration of Response (DoR)		Up to approximately 3 years
Parts 1, 2 and 3: Time to Response (TTR)		Up to approximately 3 years
Parts 1, 2 and 3: Duration of Disease Control (DC)		Up to approximately 3 years
Parts 1, 2 and 3: Progression-Free Survival (PFS)		Up to approximately 3 years
Parts 1, 2 and 3: Overall Survival (OS)		Up to approximately 5 years
Part 3 Only: Number of Participants Who Experience TEAE	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, ECGs and clinical laboratory tests will be recorded as TEAEs. 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	Up to approximately 3 years
Parts 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Parts 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Parts 1 and 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Anvumetostat		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Part 1a Only: Maximal Plasma Concentration (Cmax) of Anvumetostat		Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat		Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Anvumetostat		Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Maximal Plasma Concentration (Cmax) of Comparator Anvumetostat Test Tablet		Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Comparator Anvumetostat Test Tablet		Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Comparator Anvumetostat Test Tablet		Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1k Only: Cmax of Anvumetostat during fasted state		Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Tmax of Anvumetostat during fasted state		Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: AUC of Anvumetostat during fasted state		Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Cmax of Anvumetostat during fed state		Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Tmax of Anvumetostat during fed state		Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: AUC of Anvumetostat during fed state		Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Glioma; Gastric cancer; Non-small cell lung cancer; Pancreatic adenocarcinoma; Esophageal cancer; Metastatic MTAP-null solid tumors; Advanced MTAP-null solid tumors; Head and neck squamous cell carcinoma; Biliary Tract Cancer (BTC)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Lung Diseases; Head and Neck Neoplasms; Biliary Tract Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Esophageal Diseases; Lung Neoplasms; Carcinoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Stomach Neoplasms; Biliary Tract Neoplasms; Esophageal Neoplasms; Glioma; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel
• Other Study ID Numbers: 20210023; 2023-504363-17 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No