Status and phase
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The primary objectives of this study are to:
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Age ≥ 18 years at the time of signing informed consent.
Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have relapsed after and/or are refractory to or ineligible for established and available therapies with known clinical benefit at time of pre-screening:
Eastern Cooperative Oncology Group Performance status 0 or 1.
Life expectancy of > 3 months, in the opinion of the investigator.
At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note: this lesion should be avoided for the required biopsies on the study.
Participants must be willing to undergo 1 or more biopsies as follows:
Note: Where slides are accepted, samples must consist of a minimum of 11 (21 preferred) freshly-cut, serially, sectioned, unstained slides. A formalin-fixed, paraffin embedded block is preferred if available, but in lieu of a block, unstained slides or fresh wet tissue is acceptable.
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
535 participants in 2 patient groups
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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