A Study of MK-8033 in Patients With Advanced Solid Tumors (MK-8033-001)

A Phase I Dose Escalation Study of MK-8033 in Patients With Advanced Solid Tumors

This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK-8033.

Parts A and B of the study will determine the maximum tolerated dose (MTD) and RP2D. Part C of the study will be a single panel crossover study to determine the effect of omeprazole, a gastric pH modifier, on the pharmacokinetics of MK-8033.

Inclusion Criteria:

• Patient must be at least 18 years of age, with adequate organ function, and an Eastern Cooperative Oncology Group (ECOG) performance of <2
• Patient must be willing to undergo pre-study and post-dose tumor biopsy and have tumor accessible for biopsy (Waived during Parts A and C)

Exclusion Criteria:

• Patient is currently using bisphosphonate therapy or has received this therapy in past 6 months
• Patient has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of study participation
• Patient has history of cardiac disease
• Patient with a primary central nervous system tumor
• Patient has a known psychiatric or substance abuse disorder
• Patient is pregnant or breastfeeding, or expecting to conceive during the study
• Patient is known to be Human Immunodeficiency Virus (HIV) positive and the HIV infection is not well controlled
• Patient has received therapy with a Proton-Pump Inhibitor, Histamine2-Receptor antagonist or antacid within one week of study participation (Part B only)