Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)

Trial Title: Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)

NCT ID: NCT05514444

Condition: Advanced/Metastatic Solid Tumors
Neoplasms

Conditions: Official terms:
Neoplasms
Pembrolizumab

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: MK-4464
Description: MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation.
Arm group label: MK-4464
Arm group label: MK-4464 + Pembrolizumab
Arm group label: MK-4464 + Pembrolizumab + Zirconium 89 (89Zr)-MK-4464

Intervention type: Biological
Intervention name: Pembrolizumab
Description: Pembrolizumab 200 mg administered as an IV infusion every three weeks.
Arm group label: MK-4464 + Pembrolizumab
Arm group label: MK-4464 + Pembrolizumab + Zirconium 89 (89Zr)-MK-4464

Intervention type: Drug
Intervention name: 89Zr-MK-4464
Description: 89ZR-MK-4464 administered as an IV infusion on C1D1.
Arm group label: MK-4464 + Pembrolizumab + Zirconium 89 (89Zr)-MK-4464

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The University of Louisville, James Graham Brown Cancer Center ( Site 0100)

Address:
City: Louisville
Zip: 40245
Country: United States

Facility:
Name: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201)

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: Rambam Health Care Campus-Oncology Division ( Site 0300)

Address:
City: Haifa
Zip: 3109601
Country: Israel

Facility:
Name: Hadassah Medical Center-Oncology ( Site 0302)

Address:
City: Jerusalem
Zip: 9112001
Country: Israel

Facility:
Name: Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0401)

Address:
City: Amsterdam
Zip: 1066CX
Country: Netherlands

Facility:
Name: Amsterdam UMC, locatie VUmc ( Site 0400)

Address:
City: Amsterdam
Zip: 1081HV
Country: Netherlands

Start date: September 25, 2022

Completion date: July 17, 2026

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05514444
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=4464-001&kw=4464-001