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New targeted drug shows promise for rare genetic cancer

NCT ID NCT05094336

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called anvumetostat, alone or with chemotherapy (docetaxel), in adults with advanced solid tumors that lack the MTAP gene. The goal is to find the safest dose and see if it shrinks tumors. About 329 people will take part across multiple phases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anvumetostat (a targeted drug) and docetaxel (chemotherapy)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced cancers that lack the MTAP gene.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work or may cause serious side effects. Results may not apply to all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

329 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Biliary Tract Neoplasms Esophageal Neoplasms gastric neoplasm glioma non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced MTAP-null solid tumors

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • American Oncology Partners, PA

    Bethesda, Maryland, 20817, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Boca Raton Clinical Research Medical Center Inc

    Tamarac, Florida, 33321, United States

  • California Research Institute

    Glendale, California, 91204, United States

  • Center for Oncology and Blood Disorders

    Houston, Texas, 77030, United States

  • Centre Georges Francois Leclerc

    Dijon, 21000, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400044, China

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Community Health Network MD Anderson Cancer Center - North

    Indianapolis, Indiana, 46250, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • D and H Cancer Research Center

    Margate, Florida, 33063, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Epworth Healthcare

    East Melbourne, Victoria, 3002, Australia

  • Fomat Medical Research

    Oxnard, California, 93030, United States

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Goshen Health Systems

    Goshen, Indiana, 46526, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)

    Detroit, Michigan, 48202, United States

  • Hopitaux Universitaires Pitie Salpetriere - Charles Foix

    Paris, 75013, France

  • Hopitaux Universitaires de Geneve

    Geneva, 1211, Switzerland

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500, Switzerland

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500, Belgium

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007, Switzerland

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305, Taiwan

  • Lumi Research

    Kingwood, Texas, 77339, United States

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028, China

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

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

    New York, New York, 10016, United States

  • Northwell Health Monter Cancer Center

    Lake Success, New York, 11042, United States

  • Peter MacCallum Cancer Centre

    Parkville, Victoria, 3050, Australia

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories, Hong Kong

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong, Hong Kong

  • Roswell Park Cancer Institute

    Buffalo, New York, 32224, United States

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls, South Dakota, 54104, United States

  • Sarah Cannon Research Institute

    Dallas, Texas, 75230, United States

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123, China

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433, China

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Universitaetsklinikum Halle - Saale

    Halle, 06120, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Ulm

    Ulm, 89081, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078, Germany

  • Universitaetsspital Zuerich

    Zurich, 8091, Switzerland

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California at SF

    San Francisco, California, 94158, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19106, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908, United States

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031, United States

  • Washington University

    St Louis, Missouri, 63110, United States