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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05514444
Other study ID # 4464-001
Secondary ID MK-4464-0012021-
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 25, 2022
Est. completion date October 26, 2027

Study information

Verified date April 2024
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.


Recruitment information / eligibility

Status Recruiting
Enrollment 260
Est. completion date October 26, 2027
Est. primary completion date October 26, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MK-4464
MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation.
Pembrolizumab
Pembrolizumab 200 mg administered as an IV infusion every three weeks.
Drug:
89Zr-MK-4464
89ZR-MK-4464 administered as an IV infusion on C1D1.

Locations

Country Name City State
Canada Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201) Toronto Ontario
Israel Rambam Health Care Campus-Oncology Division ( Site 0300) Haifa
Israel Hadassah Medical Center-Oncology ( Site 0302) Jerusalem
Netherlands Amsterdam UMC, locatie VUmc ( Site 0400) Amsterdam Noord-Holland
Netherlands Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 0401) Amsterdam Noord-Holland
United States The University of Louisville, James Graham Brown Cancer Center ( Site 0100) Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary Maximum Plasma Concentration (Cmax) of MK-4464 Cmax is the maximum concentration of the drug observed in plasma. Blood samples will be collected pre-dose and post-dose at designated timepoints to determine Cmax 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
Secondary Area Under the Plasma Concentration-Time Curve (AUC) of MK-4464 AUC is a measure of the extrapolated mean concentration in serum. Blood samples will be collected pre-dose and post-dose at designated timepoints to determine AUC 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
Secondary 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 1.1). The percentage of participants who experience CR or PR as assessed by investigator assessment will be presented. Up to 24 months
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