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Experimental cancer drug AMG 199 tested in patients with stomach, colon, and pancreatic tumors

NCT ID NCT04117958

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested an experimental drug called AMG 199 in adults with advanced stomach, gastroesophageal junction, colorectal, or pancreatic cancers that have a specific protein (MUC17). The main goals were to check safety and find the best dose. The study was stopped early, so results are limited.

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

58 people

The number who actually took part.

Started

Jan 2020

Finished

Jun 2023

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: Key Inclusion Criteria: • Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma positive for MUC17. Subjects should have been refractory to or have relapsed after two or more prior lines of standard systemic therapy that included a platinum, a fluoropyrimidine, nivolumab (in combination with a platinum and a fluoropyrimidine), either a taxane or irinotecan, and an approved vascular endothelial growth factor receptor (VEGFR) antibody/tyrosine kinase inhibitor (TKI). OR • Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable colorectal cancer positive for MUC17. Subjects should have been refractory to or have relapsed after at least two and up to five prior lines of standard systemic therapy. Therapy should have included an approved vascular endothelial growth factor (VEGF) antibody (if clinically appropriate) and epidermal growth factor receptor (EGFR) antibody (if kirsten rat sarcoma \[KRAS\]/ neuroblastoma RAS viral oncogene homolog \[NRAS\]/ v-Raf murine sarcoma viral oncogene homolog B1 \[BRAF\] wild type tumor). OR * Subjects with histologically or cytologically confirmed unresectable or metastatic pancreatic ductal adenocarcinoma positive for MUC17. Subjects should have been refractory to or have relapsed after at least one and up to three prior lines of standard systemic therapy. * Gastric adenocarcinoma and GEJ adenocarcinoma: Subjects eligible for human epidermal growth factor receptor 2 (HER2) directed therapy, prior systemic therapy should have an approved HER2 targeting antibody approved for treatment of gastric cancer. For subjects with microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) tumors a prior line of treatment should have included an approved programmed cell death protein-1 (PD-1) blocking antibody. OR * Colorectal cancer: For subjects with MSI H or dMMR tumors a prior line of treatment should have included an approved PD-1-blocking antibody. For subjects with BRAF V600E mutation positive tumors a prior line of treatment should have included a BRAF inhibitor. * Subjects may also be included if the aforementioned therapeutic options were medically not appropriate for them. In these cases, the reason(s) why required prior therapies for solid tumors were medically not appropriate should be documented in the subject's electronic case report form (eCRF). Subjects may also be included if the aforementioned therapeutic options have not been available or accessible for them. * For dose expansion only: Subjects with at least one measurable lesion ≥ 10mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study. Exclusion Criteria: Key Exclusion Criteria: * Any anticancer therapy or immunotherapy within 4 weeks of start of first dose. * Central nervous system (CNS) metastases, leptomeningeal, or spinal cord compression. * Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy. Subjects may be included if the treatment is discontinued more than 3 months prior to the first dose of AMG 199, there is a low likelihood of relapse from the autoimmune disorder, AND there is agreement between the investigator and the Amgen Medical Monitor.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm gastric adenocarcinoma gastric neoplasm gastroesophageal junction adenocarcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

MUC17-positive solid tumors

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Amsterdam UMC - location VUmc

    Amsterdam, 1081 HV, Netherlands

  • Asan Medical Center

    Seoul, 138-736, South Korea

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Klinikum der Universitaet Muenchen Campus Grosshadern

    München, 81377, Germany

  • Klinikum rechts der Isar

    München, 81675, Germany

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Universitaetsklinikum Hamburg Eppendorf Onkologisches Zentrum

    Hamburg, 20246, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • University of California at Irvine Medical Center

    Orange, California, 92868, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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