Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    100
  • sponsor
    Amgen
Updated on 15 June 2022

Summary

To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Details
Condition Advanced Solid Tumors
Treatment AMG 256
Clinical Study IdentifierNCT04362748
SponsorAmgen
Last Modified on15 June 2022

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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