Can a new biologic boost the immune System's fight against advanced tumors?
NCT ID NCT05382325
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental biologic called MK-1484, given alone or with the immunotherapy drug pembrolizumab (Keytruda), in adults with advanced or metastatic solid tumors. The main goal is to assess the safety and tolerability of the treatment and to find a recommended dose for future studies. Participants will receive the drug via injection or infusion, and researchers will monitor for side effects and how the drug behaves in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MK-1484 (an experimental biologic) given alone or with pembrolizumab (Keytruda)
- What this could lead to
- If safe and effective, this combination could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is an early-phase trial focused on safety and dosing, so it is too soon to know if the treatment will work. There are risks of side effects, and the drug may not shrink tumors.
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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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- 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.
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and has received, or been intolerant to, all treatment known to confer clinical benefit. * Has measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology. * Has normal cardiac function based on transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA) * Has provided an evaluable archival or newly obtained tumor tissue sample for biomarker analysis. * Has adequate organ function. * A male participant must agree to use contraception and should refrain from donating sperm during the specified period(s) of at least 120 days after study interventions. * A female participant is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period for at least 120 days after study intervention. Exclusion Criteria: * Has and 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 Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related AEs). Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study. * 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 had a severe hypersensitivity reaction to treatment with a monoclonal antibody and/or components of the study interventions. * Has an active infection requiring therapy. * Has a history of interstitial lung disease. * Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. * Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy. * Participants with known human immunodeficiency virus (HIV) and/or hepatitis B or C infections, or known to be positive for hepatitis B surface antigen (HBsAg)/hepatitis B virus (HBV) DNA or hepatitis C Antibody or ribonucleic acid (RNA). * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, make administration of the study drugs hazardous, or make it difficult to monitor adverse effects such that it is not in the best interest of the participant to participate. * 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. Surgeries that required general anesthesia must be completed at least 2 weeks before first study intervention administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before first study intervention administration and participants should be recovered. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the start of study treatment. * Has had an allogeneic tissue/solid organ transplant in the last 5 years or has evidence of graft-versus-host disease. * Has received any prior interleukin-2 (IL-2) based therapy.
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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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Erasmus Medisch Centrum-Medical Oncology ( Site 0036)
Rotterdam, South Holland, 3015 GD, Netherlands
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NEXT Oncology ( Site 0001)
San Antonio, Texas, 78229, United States
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Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0035)
Amsterdam, North Holland, 1066CX, Netherlands
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Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0011)
Toronto, Ontario, M5G 2M9, Canada
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Rambam Health Care Campus-Oncology ( Site 0021)
Haifa, 3109601, Israel
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Sanford Cancer Center ( Site 0005)
Sioux Falls, South Dakota, 57104, United States
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Sheba Medical Center-ONCOLOGY ( Site 0020)
Ramat Gan, 5265601, Israel
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Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0037)
Utrecht, 3584 CX, Netherlands
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