New drug AMG 256 tested in patients with hard-to-treat cancers
NCT ID NCT04362748
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new drug called AMG 256 in 34 adults with advanced solid tumors that could not be cured by standard treatments. The main goals were to check the drug's safety and find the best dose for future studies. Researchers monitored side effects and how the drug moved through the body.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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34 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Sep 2023
- Lead sponsor
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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
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age ≥ 18 years at the time of signing informed consent. * Life expectancy of \> 3 months, in the opinion of the investigator. * Participant must have histologically or cytologically proven metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation for which: * No standard therapy exists, or * Standard therapy has failed, not available, or * In the investigator's opinion, standard therapy does not result in meaningful clinical benefit. * 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. Exclusion Criteria: * Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease. * History of other malignancy within the past 2 years, with the following Exceptions: * Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Adequately treated cervical carcinoma in situ without evidence of disease. * Adequately treated breast ductal carcinoma in situ without evidence of disease. * Prostatic intraepithelial neoplasia without evidence of prostate cancer. * Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ. * History of solid organ transplantation. * Major surgery within 28 days of study day 1. * Live vaccine therapy within 4 weeks prior to study day 1. * Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. * Active infection requiring oral or intravenous therapy. * Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or cardiac arrhythmia requiring medication. * History of severe allergic reactions or severe acute hypersensitivity reaction. * Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of AMG 256. * Female participants of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 3 months after the last dose of AMG 256. * Female participants of childbearing potential with a positive pregnancy test assessed within 48 hours prior to day 1 of treatment by a serum pregnancy test. * Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 5 months after the last dose of AMG 256. * Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 5 months after the last dose of AMG 256. * Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of AMG 256. * Participant has known sensitivity to any of the products or components to be administered during dosing. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participants safety or interfere with the study evaluation, procedures or completion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chris OBrien Lifehouse
Camperdown, New South Wales, 2050, Australia
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City of Hope National Medical Center
Duarte, California, 91010, United States
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Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
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Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
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Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
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Indiana University
Indianapolis, Indiana, 46202, United States
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Monash Medical Centre
Clayton, Victoria, 3168, Australia
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St Vincents Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
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Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Washington University
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors