A Study of MK-1084 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With KRASG12C Mutant Advanced Solid Tumours (MK-1084-001)

Official Title

A Phase 1, Open-Label, Multicentre Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and in Combination With Pembrolizumab in Subjects With KRASG12C Mutant Advanced Solid Tumours

Summary:

This is a study evaluating the efficacy, safety, and pharmacokinetics of MK-1084 in participants with advanced solid tumours with identified kirsten rat sarcoma viral oncogene homolog G12C (KRASG12C) mutation and MK-1084 plus pembrolizumab in participants with first line (1L) non-small cell lung cancer (NSCLSC) with identified KRASG12C mutation.

Trial Description

Primary Outcome:

• Number of participants who experienced a dose-limiting toxicity (DLT)
• Number of participants who experienced an adverse event (AE)
• Number of participants who discontinued study treatment due to an AE

• Objective response rate (ORR)
• Duration of response (DOR)
• Maximum plasma concentration (Cmax) of MK-1084
• Area under the plasma concentration-time curve (AUC) of MK-1084

View this trial on ClinicalTrials.gov