The purpose of this study is to assess the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-1484 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adults with advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Subcutaneous (SC) injection
Intravenous (IV) infusion
Sanford Cancer Center ( Site 0005)
Sioux Falls, South Dakota, United States
NEXT Oncology ( Site 0001)
San Antonio, Texas, United States
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0011)
Toronto, Ontario, Canada
Number of Participants with a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0
DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment: Grade (Gr) 4 nonhematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia: Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with clinically significant bleeding; Gr 4 anemia regardless of duration; Nonhematologic AE Gr ≥3 in severity, with exceptions; Any Gr 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required, or if abnormality leads to hospitalization, persists for \>1 week or results in drug-induced liver injury with exceptions; Gr 3 or Gr 4 febrile neutropenia; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1; Missing \>25% of the MK-1484 dose during Cycle 1 resulting from treatment-related AE; Gr 5 toxicity.
Time frame: Cycle 1 (Up to 21 days)
Number of Participants Who Experience At Least One 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Time frame: Up to approximately 27 months
Number of Participants Who Discontinue Study Treatment 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.
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Rambam Health Care Campus-Oncology ( Site 0021)
Haifa, Israel
Sheba Medical Center-ONCOLOGY ( Site 0020)
Ramat Gan, Israel
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0035)
Amsterdam, North Holland, Netherlands
Erasmus Medisch Centrum-Medical Oncology ( Site 0036)
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0037)
Utrecht, Netherlands
Time frame: Up to approximately 24 months
Area Under the Curve (AUC) of MK-1484
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Time frame: At designated time points (Up to approximately 24 months)
Minimum Serum Concentration (Cmin) of MK-1484
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmin.
Time frame: At designated time points (Up to approximately 24 months)
Maximum Serum Concentration (Cmax) of MK-1484
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax.
Time frame: At designated time points (Up to approximately 24 months)