A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumours With a Specific KRAS Mutation (CodeBreak 100)

Official Title

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumours With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreak 100)

Summary:

Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumours. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumours.

Trial Description

Primary Outcome:

• Number of Participants With Abnormal Laboratory Values
• Number of subjects with clinically significant changes in vital signs.
• Number of subjects with changes on ECG.
• Objective response rate (ORR) assessed by RECIST 1.1 criteria of AMG 510 as monotherapy in subjects with KRAS p.G12C mutated advanced tumours

• Plasma concentration (Cmax)
• Time to achieve Cmax (tmax)
• Area under the plasma concentration-time curve (AUC)
• Duration of overall response
• Progression-free survival
• Duration of stable disease

View this trial on ClinicalTrials.gov