Experimental pill takes on advanced cancers alongside immunotherapy
NCT ID NCT05594043
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This early-phase trial tests an experimental oral drug, MK-6598, both by itself and in combination with the immunotherapy pembrolizumab (Keytruda) in adults with advanced or metastatic solid tumors. The main goals are to check safety, find the right dose, and see early signs of tumor shrinkage. Participants must have tumors that can be biopsied and have already tried or cannot tolerate other standard treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called MK-6598, given as a tablet, tested alone and with the immunotherapy pembrolizumab (Keytruda)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is an early Phase 1 trial with only 39 participants, focused on safety and dosing. The drug may not prove effective or may cause significant side effects.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
39 people
The number who actually took part.
- Started
-
Dec 2022
- Finished
-
May 2025
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * 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 one or more discrete malignant lesions that are amenable to a minimum of 2 separate biopsies. * Has a baseline tumor sample that can be submitted for analysis. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART). * A participant assigned male sex at birth who receives MK-6598 must agree to use contraception and should refrain from donating sperm during the specified period(s) of at least 102 days after study interventions. * A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and at least 1 of the following: not a participant of childbearing potential (POCBP) or a POCBP who agrees to follow the contraceptive guidance during the treatment period and for up to 120 days after study intervention. Exclusion Criteria: * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention or has not recovered to CTCAE Version 5.0 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). * Known additional malignancy that is progressing or has required active treatment within 2 years. * Clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis. * A severe hypersensitivity (≥Grade 3) reaction to treatment with a monoclonal antibody/components of the study intervention. * Active infection requiring therapy. * History of interstitial lung disease. * History of (noninfectious) pneumonitis that required steroids or current pneumonitis. * Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed. * Has known hepatitis B or C infections or known to be positive for hepatitis B surface antigen (HBsAg)/hepatitis B virus (HBV) deoxyribonucleic acid (DNA) or hepatitis C antibody or ribonucleic acid (RNA). * Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Received prior radiotherapy within 2 weeks of start of study intervention, has radiation-related toxicities requiring corticosteroids, or had a history of radiation pneumonitis. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, CD137), and was discontinued from that treatment due to a ≥Grade 3 immune-related AE (irAE). * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced or metastatic solid tumors are added.
By submitting, you agree to our Terms of use
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
-
Cantonal Hospital St.Gallen ( Site 0203)
Sankt Gallen, 9007, Switzerland
-
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)
Montreal, Quebec, H2X 0A9, Canada
-
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Geneva, Canton of Geneva, 1211, Switzerland
-
Ospedale Regionale Bellinzona e Valli ( Site 0200)
Bellinzona, Canton Ticino, 6500, Switzerland
-
Princess Margaret Cancer Centre ( Site 0101)
Toronto, Ontario, M5G 2M9, Canada
-
Sanford Cancer Center ( Site 0300)
Sioux Falls, South Dakota, 57104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a new pill shrink advanced solid tumors?
- Can a new drug duo shrink Hard-to-Treat tumors?
- Can a Tumor-Directed injection shrink Hard-to-Treat cancers?
- Can a new gemcitabine formulation outsmart advanced solid tumors?