New drug combo tested for Hard-to-Treat cancers
NCT ID NCT05514444
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called MK-4464, given alone or with another drug (pembrolizumab), in 64 people with advanced solid tumors that had not responded to standard treatments. The main goals were to check the safety of the drug and how the body processes it. This is a first step to see if the drug is safe enough for further testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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64 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Amsterdam UMC, locatie VUmc ( Site 0400)
Amsterdam, North Holland, 1081HV, Netherlands
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Hadassah Medical Center-Oncology ( Site 0302)
Jerusalem, 9112001, Israel
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Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0401)
Amsterdam, North Holland, 1066CX, Netherlands
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Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201)
Toronto, Ontario, M5G 2M9, Canada
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Rambam Health Care Campus-Oncology Division ( Site 0300)
Haifa, 3109601, Israel
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The University of Louisville, James Graham Brown Cancer Center ( Site 0100)
Louisville, Kentucky, 40245, United States
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Other studies related to the condition(s) this trial covers.
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- Can radiation plus two immunotherapies shrink Hard-to-Treat tumors?