Study of MK-4464 as Monotherapy and in Combination With P... | NCT05514444

ID	Type	Description
MK-4464-001	Other Identifier	MSD
2023-504855-28-00	Registry Identifier	EU CT
U1111-1290-2697	Registry Identifier	UTN
2021-005882-42	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MK-4464	Experimental	Participants will receive an intravenous (IV) infusion of MK-4464 administered in escalating doses every 3 weeks for up to 35 cycles. Escalation to subsequent MK-4464 doses will be based on safety of previous dose.	Biological: MK-4464
MK-4464 + Pembrolizumab	Experimental	Participants will receive an IV infusion of MK-4464 administered in escalating doses and a 200 mg IV infusion of Pembrolizumab every 3 weeks for up to 35 cycles. Escalation to subsequent MK-4464 doses will be based on safety of MK-4464 monotherapy arm.	Biological: MK-4464 Biological: Pembrolizumab
MK-4464 + Pembrolizumab + Zirconium 89 (89Zr)-MK-4464	Experimental	Participants will receive an IV infusion of 89Zr-MK-4464 + IV infusion of MK-4464 on Cycle 1 Day 1, followed by an IV infusion of MK-4464 + a 200 mg IV infusion of pembrolizumab starting on Cycle 2 Day 1 and every 3 weeks for up to 35 cycles. Each cycle=3 weeks. MK-4464 doses will be based on safety of MK-4464 monotherapy arm. Participants may receive a 200 mg IV infusion of pembrolizumab on cycle 36.	Biological: MK-4464 Biological: Pembrolizumab Drug: 89Zr-MK-4464

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK-4464	Biological	MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation.	MK-4464 MK-4464 + Pembrolizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)	A DLT is any toxicity assessed by the investigator to be possibly, probably, or definitely related to study intervention administration that results in a change to a given dose or a delay in initiating the next cycle. All toxicities will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).	Up to approximately 21 days
Number of Participants Who Experience At Least One adverse event (AE)	An AE is defined as 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 at least one AE will be presented.	Up to approximately 27 months
Number of Participants Who Discontinue Study Treatment Due to an AE	An AE is defined as 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 treatment due to an AE will be presented.	Up to approximately 24 months

Secondary Outcomes

Measure	Description	Time Frame
Minimum Plasma Concentration (Cmin) of MK-4464	Cmin is the minimum concentration of the drug observed in plasma. Blood samples will be collected pre-dose and post-dose at designated timepoints to determine Cmin of MK-4464.	Once daily on Day 2, 3, 5, 8, 15 of Cycle 1 and 4, Pre-dose and immediately Post-dose Day 1 Cycle 1, 2, 3, 4, Pre-dose Day 1 Cycles 5, 6, 7, 8, and every 4 cycles thereafter through Cycle 35, 30 days post last dose (up to ~25 months); Cycle = 21 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The key Inclusion Criteria include but are not limited to the following:

Have a histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit
Must submit a baseline tumor sample for analysis
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.

Exclusion Criteria:

The key Exclusion Criteria include but are not limited to the following:

Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention or has not recovered to CTCAE Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring therapy
History of an allogenic stem cell transplant or a solid organ transplant
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active autoimmune disease that has required systemic treatment in the past 2 years
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the study
Has not fully recovered from any effects of major surgery without significant detectable infection
Has received radiation therapy to the lung that is >30 gray (Gy) within 6 months of the first dose of study treatment
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is currently participating and receiving study intervention in a study of an investigational agent or has participated and received study intervention in a study of an investigational agent or has used an investigational device within 28 days

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source