A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)
ConditionMetastatic Neoplasm
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has histologically or cytologically confirmed advanced/metastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, breast cancer (triple negative breast cancer, Estrogen Receptor [ER]/progesterone receptor +, human epidermal growth factor receptor 2 negative [HER2-]), endometrial, and bladder cancer by pathology report and have previously failed standard treatment, lack standard treatment options, or are intolerant to standard treatment
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Disqualifiers
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has a history of New York Heart Association Class II or greater heart failure
Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
Has ongoing radiation-related toxicities, requiring corticosteroids
Trial design
Design model
Sequential
Treatments tested in this trial
MK-8294
Drug30 µg via intravenous (IV) infusion
MK-8294
Drug100 µg via intravenous (IV) infusion
MK-8294
Drug300 µg via intravenous (IV) infusion
MK-8294
Drug1 mg via intravenous (IV) infusion
MK-8294
Drug3 mg via intravenous (IV) infusion
MK-8294
Drug10 mg via intravenous (IV) infusion
MK-8294
Drug30 mg via intravenous (IV) infusion
MK-8294
Drug70 mg via intravenous (IV) infusion
CD8 PET Tracer
Other interventionIV Infusion
Treatment groups
67 Participants
are divided into 1 treatment groupGroup A: MK-8294Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants who experience one or more dose-limiting toxicities (DLTs)
DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period (up to 35 days) that results in a change to a given dose or a delay in initiating the next treatment and reported as the number of participants experiencing a DLT.
Time frame
Up to approximately 35 days2
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Time frame
Up to approximately 2 years3
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study/study treatment due to an AE will be reported.
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Time frame
Up to approximately 2 years2
Area Under the Plasma Concentration-Time Curve (AUC) of MK-8294
Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Area Under the Concentration-Time Curve of MK-8294.
Time frame
Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)3
Minimum Concentration (Cmin) of MK-8294
Cmin is defined as the lowest concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmin of MK-8294.
Time frame
Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)4
Maximum Plasma Concentration (Cmax) of MK-8294
Cmax is defined as the peak concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmax of MK-8294.
Time frame
Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov