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Recruiting Phase 1 NCT05853367

Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

Trial Parameters

Condition Metastatic Solid Tumors
Sponsor Merck Sharp & Dohme LLC
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 178
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-07-06
Completion 2028-02-12
Interventions
MK-0472PembrolizumabMK-1084

Brief Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.

Eligibility Criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (\>4 weeks) antiretroviral therapy (ART) * Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing (tissue or blood) and have received, or been intolerant to, all available treatment known to confer clinical benefit * Arm 2: Tumor types known to be sensitive to anti-programmed cell death 1 prote

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