AzTrials
AzTrials

Thoracic TumorsPhase 1NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

A Phase 1 study testing Anvumetostat, Carboplatin and Paclitaxel in people with Thoracic Tumors and Non-small Cell Lung Cancer, run by Amgen at 83 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Thoracic Tumors, Non-small Cell Lung Cancer
What is being tested?
Anvumetostat, Carboplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
83 sitesin 20 countries
Study dates
17 Sep 2024to 30 Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subprotocol A, B, and C
  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  • Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before Anvumetostat dosing.
  • Homozygous MTAP-deletion
  • Able to swallow and retain PO administered study treatment.
  • Disease measurable as defined by RECIST v1.1.
Show all 17Show fewer
  • Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.
  • Arm A (Anvumetostat + carboplatin + paclitaxel + pembrolizumab):
  • Predominantly squamous histology.
  • Arm B (Anvumetostat + carboplatin + pemetrexed + pembrolizumab):
  • Predominantly non-squamous histology.
  • Arm C (Anvumetostat + pembrolizumab):
  • PD-L1 positive.
  • Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.
  • Subprotocol C
  • Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
  • Brain lesion meeting RANO-BM criteria for measurable disease.

Who cannot join

  • Subprotocol A, B, and C
  • Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
  • Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
  • History of solid organ transplant.
  • Major surgery within 28 days of first dose of Anvumetostat.
  • Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
Show all 9Show fewer
  • Radiation therapy within 28 days of first dose.
  • Subprotocol A
  • Autoimmune disease or immunodeficiency disease as defined in the protocol'

Trial locations and contacts

83 sites in 20 countries.

83 sites in 20 countries

United States26 sites

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Roswell Park Cancer Institute

    Buffalo, New York, 32224

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75246

  • US Oncology Research Investigational Products Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • City of Hope National Medical Center

    Duarte, California, 91010

  • City of Hope Orange County Lennar Foundation Cancer Center

    Duarte, California, 91010

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031

  • Oncology Consultants Cancer Center

    Houston, Texas, 77030

  • Saint Lukes Hospital of Kansas City

    Kansas City, Missouri, 64111

  • University of Tennessee Medical Center Knoxville

    Knoxville, Tennessee, 37920

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Translational Research in Oncology US Inc, Trio Central Pharmacy

    Los Angeles, California, 90095

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203

  • New York University Grossman School of Medicine

    New York, New York, 10016

  • Perlmutter Cancer Center at New York University Langone Hospital----Long Island

    New York, New York, 10016

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • University of California Irvine

    Orange, California, 92868-3217

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • HealthPartners Institute

    Saint Paul, Minnesota, 55102

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Upstate University Hospital

    Syracuse, New York, 13210

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702

Other trials in United States

China7 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Brazil5 sites

  • Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Cipo - Centro Integrado de Pesquisa em Oncologia

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Fund Faculdade Regional Med Sao Jose Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Beneficencia Portuguesa de Sao Paulo - Bp

    São Paulo, São Paulo, 01509-900

  • Instituto Cancer Sao Paulo Icesp

    São Paulo, 01246-000

Other trials in Brazil

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Gliwice, 44-102

  • Futuremeds spolka z ograniczona odpowiedzialnoscia

    Krakow, 31-501

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, 20-701

Other trials in Poland

France4 sites

  • Institut Bergonie

    Bordeaux, 33000

  • Hopital de la Timone

    Marseille, 13005

  • Institut de Cancerologie de l Ouest Rene Gauducheau

    Saint-Herblain, 44805

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy4 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Alessandria, 15100

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • IRCCS Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    Verona, 37126

Other trials in Italy

Japan4 sites

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

Other trials in Japan

Argentina3 sites

  • Instituto Argentino de Diagnóstico y Tratamiento

    Ciudad Automona de Buenos Aires, Buenos Aires, C1117ABC

  • Cemic

    Ciudad Autonoma Buenos Aires, C1431FWO

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT

Other trials in Argentina

Germany3 sites

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69126

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Greece3 sites

  • Alexandra Hospital

    Athens, 11528

  • General Hospital Of Thessaloniki Papageorgiou

    Thessaloniki, 56429

  • European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

Spain3 sites

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

Turkey (Türkiye)3 sites

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, 01370

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06230

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

Other trials in Turkey (Türkiye)

Australia2 sites

  • Orange Health Service

    Orange, New South Wales, 2800

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Austria2 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

Other trials in Austria

Hong Kong2 sites

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories

Other trials in Hong Kong

South Korea2 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Taiwan2 sites

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Belgium1 site

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

Other trials in Belgium

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Netherlands1 site

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

Other trials in Netherlands

About this study

Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

Being tested
Anvumetostat, Carboplatin, Paclitaxel, Pembrolizumab, Pemetrexed
Keywords
Oncology, Methylthioadenosine phosphorylase, AMG 193, PRMT5 inhibitor, MTAP, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06333951
Study groupRoleWhat they receive
Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm AExperimentalParticipants with MTAP-deleted NSCLC will receive a regimen of Anvumetostat orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV)
Receives: Drug: Anvumetostat; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pembrolizumab
Subprotocol A: NSCLC Arm BExperimentalParticipants with MTAP-deleted NSCLC will receive a regimen of Anvumetostat PO and carboplatin, pemetrexed, and pembrolizumab IV
Receives: Drug: Anvumetostat; Drug: Carboplatin; Drug: Pembrolizumab; Drug: Pemetrexed
Subprotocol A: NSCLC Arm CExperimentalParticipants with MTAP-deleted NSCLC will receive a combination of Anvumetostat PO and pembrolizumab IV
Receives: Drug: Anvumetostat; Drug: Pembrolizumab
Subprotocol B: NSCLC With KRasG12C MutationExperimentalParticipants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of Anvumetostat and sotorasib PO
Receives: Drug: Anvumetostat; Drug: Sotorasib
Subprotocol C: NSCLC With Brain MetastasesExperimentalParticipants with MTAP-deleted NSCLC with brain metastases will receive Anvumetostat PO
Receives: Drug: Anvumetostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose Limiting Toxicities (DLT)

    Measured: Up to approximately 21 days

  2. Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

    TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

    Measured: Up to approximately 3 years

  3. Number of Participants Experiencing Serious Adverse Events (SAE)

    An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to approximately 3 years

Secondary outcomes (13)

  1. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: Up to approximately 3 years

  2. Disease Control (DC) per RECIST v1.1

    Measured: Up to approximately 3 years

  3. Duration of Response (DOR) per RECIST v1.1

    Measured: Up to approximately 3 years

  4. Time to Response (TTR) per RECIST v1.1

    Measured: Up to approximately 3 years

  5. Overall Survival (OS) per RECIST v1.1

    Measured: Up to approximately 3 years

  6. Progression-free Survival (PFS) per RECIST v1.1

    Measured: Up to approximately 3 years

  7. Maximum Plasma Concentration (Cmax) of Anvumetostat

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 days)

  8. Time to Maximum Plasma Concentration (tmax) of Anvumetostat

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 days)

  9. Area Under the Plasma Concentration-time Curve (AUC) of Anvumetostat

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 days)

  10. Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM )

    Measured: Up to approximately 3 years

  11. Intracranial Disease Control (IDC) per RANO-BM

    Measured: Up to approximately 3 years

  12. Intracranial Duration of Response (IDOR) per RANO-BM

    Measured: Up to approximately 3 years

  13. Time to Intracranial Radiation Therapy per RANO-BM

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start17 Sep 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333951
Sponsor's protocol ID
20230167
Status last verified
May 2026
First submitted
21 Mar 2024
Last updated
28 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anvumetostat, Carboplatin and Paclitaxel in people with Thoracic Tumors and Non-small Cell Lung Cancer, run by Amgen at 83 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, China, Brazil, Poland, France and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose Limiting Toxicities (DLT) (time frame: Up to approximately 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06333951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in