To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
AMG 650 administered orally as a tablet.
The Angeles Clinic and Research Institute, West Los Angeles Office
Los Angeles, California, United States
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 12 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 24 months
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 24 months
Number of Participants with Treatment-related Adverse Events
Time frame: Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement
Time frame: Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement
Time frame: Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Time frame: Up to 24 months
Objective Response Rate (ORR)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Progression-free Survival (PFS)
Time frame: Up to 24 months
Clinical Benefit Rate (CBR)
Time frame: Up to 24 months
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Time to Response (TTR)
Time frame: Up to 24 months
Time to Progression (TTP)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Maximum Plasma Concentration (Cmax) of AMG 650
Time frame: Up to 24 months
Time to Maximum Plasma Concentration (Tmax) of AMG 650
Time frame: Up to 24 months
Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650
Time frame: Up to 24 months