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New combo targets Hard-to-Treat cancers with missing gene

NCT ID NCT05975073

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new two-drug combination (anvumetostat and IDE397) in 53 adults with advanced solid tumors that lack a gene called MTAP. The goal was to find a safe dose and see if the drugs shrink tumors, especially in lung cancer. Participants had cancers that had stopped responding to standard treatments.

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

53 people

The number who actually took part.

Started

Aug 2023

Finished

Mar 2026

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 years and older

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 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.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

MTAP-null non-small-cell lung cancer MTAP-null solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816, United States

  • City of Hope National Medical Center

    Duarte, California, 91090, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Community Health Network MD Anderson Cancer Center - North

    Indianapolis, Indiana, 46250, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55102, United States

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • 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

  • Next Oncology

    Irving, Texas, 75039, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Prisma Health Upstate

    Greenville, South Carolina, 29605, United States

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218, United States

  • 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

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011, Australia

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States