Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

Official Title

A Phase I/II, Multicentre, Open-label Study of MAK683 in Adult Patients With Advanced Malignancies

Summary:

The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumour activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumours for whom no further effective standard treatment is available.

Trial Description

Primary Outcome:

• Incidence of dose limiting toxicities (DLTs)
• Safety and tolerability

Secondary Outcome:

• Overall Response Rate (ORR)
• Duration of overall response (DOR)
• Progression-free survival (PFS)
• Best Overall Response (BOR)
• Peak Plasma Concentration (Cmax) of MAK683
• Area Under the Plasma Concentration (AUC) Time Curve of MAK683
• Half-Life of MAK683
• H3K27 tri methylation level in PBMC

The purpose phase I of this trial is to characterize safety and tolerability and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of MAK683. The purpose of the phase II of this trial will be to evaluate the anti-tumour activity of MAK683.

View this trial on ClinicalTrials.gov