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New drug AMG 305 tested in patients with advanced cancers

NCT ID NCT05800964

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested a new drug called AMG 305 in 37 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check the drug's safety and find the best dose for future studies. Participants received the drug and were monitored for side effects and how the drug moved through their bodies.

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

37 people

The number who actually took part.

Started

Jun 2023

Finished

Jan 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 to 100 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.

Key Inclusion Criteria: * Participant has provided informed consent to the main study prior to initiation of any study specific activities/procedures * Male or female participants age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participants with histologically or cytologically documented selected solid tumor diseases. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy * For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study * Life expectancy \> 3 months * Adequate organ function Key Exclusion Criteria: * Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression * History of other malignancy within the past 2 years * Ongoing or active infection (including chronic or localized) * Any pleural effusion or pericardial effusion within 4 weeks or ascites requiring recurrent drainage procedures or other medical intervention within 2 weeks prior to the first dose of the investigational products. * Known interstitial lung disease * Positive test for human immunodeficiency virus (HIV) * Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR) * History of non-infectious/immune-checkpoint inhibitor related pneumonitis that required corticosteroids, or current or suspected pneumonitis that cannot be ruled out by imaging at screening. * Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors (TKI) within 4 weeks of administration of the first dose of AMG 305; checkpoint inhibitor therapy within 3 months of the first dose of AMG 305; or other immunotherapies/monoclonal antibodies within 3 weeks of administration of the first dose of AMG 305. * Has had a major surgery within 4 weeks of administration of a first dose of study treatment * Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease) * Live and/or live-attenuated vaccines received within 28 days (or longer, if required locally) prior to the first dose of AMG 305 * Participants with unresolved toxicities from prior anti-tumor therapies to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or better, with the exception of alopecia and grade 2 peripheral neuropathy, which has been unchanged within the last 2 months and there is agreement to allow by both the investigator and sponsor * Currently receiving treatment in another investigational device or drug study * Female participants of childbearing potential or male participants unwilling to use protocol specified method of contraception * Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant while on study * History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Freeman Hospital

    Newcastle, NE7 7DN, United Kingdom

  • Gustave Roussy

    Villejuif, 94805, France

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Madrid Sanchinarro

    Madrid, 28050, Spain

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059, France

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • New York University Cancer Institute

    New York, New York, 10016, United States

  • Next Oncology

    San Antonio, Texas, 78229, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1, Canada

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Universitaetsklinikum Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078, Germany

  • University College London Hospital

    London, W1T 7HA, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.