A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors

Inclusion Criteria

• •Men or women ≥ 18 years old
• •Part 1 Dose Escalation only: advanced solid tumor refractory to standard treatment for which no standard therapy is available or the subject refuses standard therapy
• •Part 1 Dose Escalation only: Measurable or evaluable disease per RECIST guidelines
• •Part 2 Dose Expansion only: Taxane-resistant tumor (defined as refractory to or progression within 6 months of discontinuing paclitaxel or docetaxel) of prespecified histology
• •Part 2 Dose Expansion only: Measurable disease per RECIST guidelines
• •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
• •Life expectancy of \> 3 months, in the opinion of the investigator
• •Willing to provide existing and/or future paraffin-embedded tumor samples
• •Part 1 Dose Escalation: must have tumor tissue that is accessible for biopsy by fine needle aspiration (FNA) and must consent to undergo biopsies of their tumor (subjects in non-accelerated phase only)
• •Ability to take oral medications
• +29 more criteria