Clinical trial · Interventional
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors
NCT05514444CI-TRIAL-00096440completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced/Metastatic Solid Tumors | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-MK-4464 | Drug | — | UNRESOLVED |
| MK-4464 | Biological | — | UNRESOLVED |
| Pembrolizumab | Biological | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- MK-4464
- description
- 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.
- interventionNames
- Biological: MK-4464
- type
- EXPERIMENTAL
- label
- MK-4464 + Pembrolizumab
- description
- 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.
- interventionNames
- Biological: MK-4464
- Biological: Pembrolizumab
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.