Study of AMG 650 in Adult Participants With Advanced Solid Tumours

Official Title

A Phase 1, Multicentre, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumours

Summary:

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).

Trial Description

Primary Outcome:

• Number of Participants with Dose Limiting Toxicities (DLTs)
• Number of Participants with Treatment-emergent Adverse Events (TEAEs)
• Number of Participants with Serious Adverse Events (SAEs)
• Number of Participants with Treatment-related Adverse Events
• Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement
• Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement
• Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests

• Objective Response Rate (ORR)
• Duration of Response (DOR)
• Progression-free Survival (PFS)
• Clinical Benefit Rate (CBR)
• Time to Response (TTR)
• Time to Progression (TTP)
• Overall Survival (OS)
• Maximum Plasma Concentration (Cmax) of AMG 650
• Time to Maximum Plasma Concentration (Tmax) of AMG 650
• Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650

View this trial on ClinicalTrials.gov