The primary purpose of the phase 1 part of the study is to estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, RP2D) and to confirm the safety and tolerability of the RP2D. The dose escalation part of the study will be conducted at multiple sites and test increasing doses and dosing schedules of AMG 701. This will be followed by Phase 1b dose confirmation and Phase 2 dose expansion parts to gain further efficacy and safety experience with AMG 701. The safety of subjects will be monitored by intensive assessments of vital signs, electrocardiograms, physical examinations, and laboratory tests.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.