A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)
NCT Number: NCT06460961
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Neoplasm Metastasis
Interventions: BIOLOGICAL: MK-6837|BIOLOGICAL: Pembrolizumab
Sponsor: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-14
Completion Date: 2029-07-13
Locations: Atlantic Health System Morristown Medical Center ( Site 4001), Morristown, New Jersey, 07960, United States|Sheba Medical Center-ONCOLOGY ( Site 3001), Ramat Gan, 5265601, Israel

Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MK-6837, administered as a monotherapy and in combination with pembrolizumab (MK-3475), in participants with histologically or cytologically confirmed advanced/metastatic solid tumors that have not responded to conventional therapy. There will not be any hypothesis testing in the study.

Primary Outcome Measures: Number of participants who experience one or more dose-limiting toxicities (DLTs), The following events will be considered a DLT unless clearly due to underlying disease or extraneous causes: Grade 4 neutropenia lasting \>7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding, regardless of duration; All Grade 3 or higher nonhematologic toxicities (with exceptions); Any abnormality that results in a drug induced liver injury; Febrile neutropenia Grade 3 or 4; Prolonged delay (\>2 weeks) in initiating treatment after the first 21 days due to intervention-related toxicity; Any intervention-related toxicity that causes the participant to discontinue intervention during the first 21 days; Grade 5 toxicity. The number of participants who experience a DLT will be presented., Cycle 1 (Up to approximately 21 days); each cycle is 21 days.|Number of participants who experience one or more adverse events (AEs), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 59 months|Number of participants who discontinue study intervention due to an AE, An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 59 months
Secondary Outcome Measures: Maximum concentration (Cmax) of MK-6837 in plasma, The Cmax of MK-6837 in plasma will be determined., Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days|Minimum concentration (Ctrough) of MK-6837 in plasma, The Ctrough of MK-6837 in plasma will be determined., Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days|Area Under the Concentration-Time Curve (AUC) of MK-6837 in plasma, The AUC of MK-6837 in plasma will be determined., Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days