Study of AMG 650 in Adult Participants With Advanced Solid Tumours

Titre officiel

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

Sommaire:

Évaluation de l’innocuité et de la tolérabilité d’AMG 650 chez des participants adultes et détermination de la dose maximale tolérée (DMT) ou de la dose recommandée pour la phase II (DRP2).

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov