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New drug AMG 436 targets tough cancers in early trial

NCT ID NCT07403721

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 8 times

Summary

This early-phase trial is testing a new drug called AMG 436, alone or with other cancer treatments, in adults with advanced solid tumors that have high microsatellite instability or mismatch repair deficiency. The main goals are to check safety, find the best dose, and see how the drug moves through the body. About 464 participants will be enrolled.

What this could mean

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

Active substance
AMG 436
What this could lead to
If successful, this could lead to a new treatment option for people with hard-to-treat cancers that have specific genetic features.
What could go wrong
This is an early phase 1 trial focused on safety and dosing, so it is unknown if AMG 436 will effectively shrink tumors or improve survival. Side effects are possible.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 464 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2028

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 99 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: * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years). * Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing. * Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing. * Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). * Eastern Cooperative Oncology Group performance (ECOG) 0-1. * Adequate organ function as defined in the protocol. Exclusion Criteria: * Participants with primary central nervous system (CNS) tumors. * Impaired cardiac function or clinically significant cardiac disease. * Major surgery within 28 days of trial day 1. * Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 21 days (in this case, enrollment may be allowed with washout from prior therapy of \< 21 days. * Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose). * Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis

As listed by the trial registrant

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

Metastatic or locally advanced solid tumors with microsatellite instability-high (msi-H) or mismatched repair deficiency (DMMR)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aichi Cancer Center

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Calvary Mater Newcastle Hospital

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • City of Hope Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • Clinica Universidad de Navarra

    RECRUITING

    Madrid, 28027, Spain

  • Community Health Network MD Anderson Cancer Center - North

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hopital Saint Antoine

    RECRUITING

    Paris, 75012, France

  • Hospital Clinic i Provincial de Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Midwestern Regional Medical Center dba City of Hope Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • New England Cancer Specialists

    RECRUITING

    Westbrook, Maine, 04092, United States

  • Next Oncology - Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

  • Sun Yat-Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • Tennessee Oncology PLLC

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China