A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

April 21, 2026 updated by: Amgen

A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors

The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of Anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • 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
  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Hospital Universitari Vall d Hebron
  • Taiwan
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
  • United States
    • California
      • Duarte, California, United States, 91090
        • City of Hope National Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network MD Anderson Cancer Center - North
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • Health Partners Cancer Center at Regions Hospital
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Astera Cancer Care
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10032
        • Columbia University Irving Medical 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
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Upstate
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • Irving, Texas, United States, 75039
        • NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.

  2. Presence of advanced/metastatic solid tumor not amenable to curative treatment

    1. Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
    2. Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
  3. Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
  4. Disease measurable as defined by RECIST v1.1
  5. Adequate organ function as defined in the protocol.
  6. Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.

Exclusion Criteria

  1. Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
  2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
  3. Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
  4. 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)
  5. History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
  6. Prior irradiation to > 25% of the bone marrow
  7. Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Dose Exploration of Anvumetostat Combined With IDE397
Participants will receive escalating doses of Anvumetostat and IDE397 administered orally (PO) in cycles of 21 days.
Drug: IDE397
Administered PO
Drug: Anvumetostat
Administered PO
Other Names:
  • AMG 193
Experimental: Part 2: Dose Expansion of Anvumetostat Combined With IDE397
Anvumetostat and IDE397 will be administered PO in cycles of 21 days.
Drug: IDE397
Administered PO
Drug: Anvumetostat
Administered PO
Other Names:
  • AMG 193

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time Frame: Day 1 up to Day 21
Day 1 up to Day 21
Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 up to approximately 2.5 years
Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
Day 1 up to approximately 2.5 years
Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame: Day 1 up to approximately 2.5 years
Day 1 up to approximately 2.5 years
Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame: Day 1 up to approximately 2.5 years
Day 1 up to approximately 2.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1 and 2: Cmax of IDE397
Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Tmax of IDE397
Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: AUC After Single Dose of IDE397
Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: AUC After Multiple Doses of IDE397
Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1: Overall Response per RECIST 1.1
Time Frame: Day 1 up to end-of-study (EOS) (approximately 2.5 years)
Day 1 up to end-of-study (EOS) (approximately 2.5 years)
Parts 1 and 2: Disease Control Rate
Time Frame: Day 1 up to EOS (approximately 2.5 years)
Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Time to Response (TTR)
Time Frame: Day 1 up to EOS (approximately 2.5 years)
Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Duration of Response (DOR)
Time Frame: Day 1 up to EOS (approximately 2.5 years)
Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Duration of Stable Disease
Time Frame: Day 1 up to EOT (approximately 6 months)
Day 1 up to EOT (approximately 6 months)
Parts 1 and 2: Progression-free Survival (PFS)
Time Frame: Day 1 up to EOS (approximately 2.5 years)
Day 1 up to EOS (approximately 2.5 years)
Parts 1 and 2: Overall Survival (OS)
Time Frame: Day 1 up to EOS (approximately 2.5 years)
Day 1 up to EOS (approximately 2.5 years)
Part 2: Number of Participants Experiencing TEAEs
Time Frame: Day 1 up to approximately 2.5 years
Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
Day 1 up to approximately 2.5 years
Part 2: Number of Participants Experiencing SAEs
Time Frame: Day 1 up to approximately 2.5 years
Day 1 up to approximately 2.5 years
Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood
Time Frame: Baseline (Day 1) to EOT plus 30 days (approximately 7 months)
Baseline (Day 1) to EOT plus 30 days (approximately 7 months)
Part 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat
Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat
Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of Anvumetostat
Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of Anvumetostat
Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20220127

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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