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

• Status: Recruiting
• Trial end date: 2027-10-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC
• Treatments: Pembrolizumab

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