Malignant NeoplasmPhase 1NCT07600749
Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)
A Phase 1 study testing MK-4884 in people with Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 10 sites in 5 countries.
Trial summary
Researchers are looking for new ways to treat certain types of advanced and/or metastatic solid tumors. The main goal of this study is to learn about the safety of different doses of MK-4884 and if participants tolerate them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- MK-4884
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 18 Jun 2026to 4 Oct 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a histologically or cytologically confirmed diagnosis of 1 of the following unresectable (locally advanced) and/or advanced (metastatic) solid tumors:
- Colorectal carcinoma (CRC)
- Renal cell carcinoma (RCC) that contains a clear cell component (with or without sarcomatoid and/or rhabdoid features)
- Nonsquamous non-small cell lung cancer (NSCLC)
- Biliary tract cancer (BTC) (intra-or extrahepatic cholangiocarcinoma (CCA)) or gallbladder cancer (GBC)
- Has measurable disease by Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1)
Show all 10Show fewer
- Has adequate organ function
- Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable antiretroviral therapy (ART) for at least 4 weeks
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Who cannot join
- Has gastrointestinal malabsorption, a surgical procedure or a condition that could affect the absorption of the study drug
- Has a history of clinically significant cardiac, cardiovascular and/or cerebrovascular disease
- Has a serious nonhealing wound, ulcer, or bone fracture
- Has an active infection(s) requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
Show all 9Show fewer
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 5 countries
Switzerland3 sites, 3 recruiting
- Recruiting
Ospedale Regionale Bellinzona e Valli ( Site 0104)
Bellinzona, Canton Ticino, 6500
Study Coordinator, 0041 091 811 91 11
- Recruiting
CHUV (centre hospitalier universitaire vaudois) ( Site 0103)
Lausanne, Canton of Vaud, 1011
Study Coordinator, +41213140155
- Recruiting
Cantonal Hospital St.Gallen ( Site 0101)
Sankt Gallen, Canton of St. Gallen, 9007
Study Coordinator, +41 55 285 41 11
United States2 sites, 2 recruiting
- Recruiting
NEXT Oncology ( Site 0151)
San Antonio, Texas, 78229
Study Coordinator, 210-568-4397
- Recruiting
Siteman Cancer Center ( Site 0153)
St Louis, Missouri, 63108
Study Coordinator, 314-273-8602
Canada2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0002)
Montreal, Quebec, H2X 0A9
Study Coordinator, 514-890-8000
- Recruiting
Princess Margaret Cancer Centre ( Site 0004)
Toronto, Ontario, M5G 2M9
Study Coordinator, 416-596-4200
Israel2 sites, 2 recruiting
- Recruiting
Rambam Health Care Campus ( Site 0051)
Haifa, 3109601
Study Coordinator, +97247776731
- Recruiting
Rabin Medical Center ( Site 0053)
Petah Tikva, 4941492
Study Coordinator, +97239377377
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital ( Site 0201)
Chūō, Tokyo, 104-0045
Study Coordinator, +81-3-3542-2511
About this study
Official title: A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-4884 in Participants With Advanced/Metastatic Solid Tumors
Researchers are looking for new ways to treat certain types of advanced and/or metastatic solid tumors.
The main goal of this study is to learn about the safety of different doses of MK-4884 and if participants tolerate them.
- Conditions
- Malignant Neoplasm
- Being tested
- MK-4884
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4884Drug
Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| MK-4884 Dose Escalation Schedule A | Experimental | Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met. Receives: Drug: MK-4884 |
| MK-4884 Dose Escalation Schedule B | Experimental | Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met. Receives: Drug: MK-4884 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
Measured: Up to approximately 21 days
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with experience an AE will be reported.
Measured: Up to approximately 39 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE will be reported.
Measured: Up to approximately 39 months
Secondary outcomes (5)
Area Under the Concentration-Time Curve (AUC) of MK-4884
Blood samples will be collected to determine the AUC of MK-4884 in plasma.
Measured: At designated timepoints (up to approximately 15 days)
Maximum Plasma Concentration (Cmax) of MK-4884
Blood samples will be collected to determine the Cmax of MK-4884 in plasma.
Measured: At designated timepoints (up to approximately 15 days)
Trough Plasma Concentration (Ctrough) of MK-4884
Blood samples will be collected to determine the Ctrough of MK-4884 in plasma.
Measured: At designated timepoints (up to approximately 39 months)
Time to Maximum Plasma Concentration (Tmax) of MK-4884
Blood samples will be collected to determine the Tmax of MK-4884 in plasma.
Measured: At designated timepoints (up to approximately 15 days)
Apparent Terminal Half-life (t½) of MK-4884
Blood samples will be collected to determine the t1/2 of MK-4884 in plasma.
Measured: At designated timepoints (up to approximately 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start18 Jun 2026
- Primary completion4 Oct 2029 (estimated)
- Study completion4 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600749
- Sponsor's protocol ID
- 4884-001
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-4884 in Participants With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07600749
- Acronym / sponsor ID
- 4884-001
- Conditions
- Malignant Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 4 Oct 2029 (estimated)
- Study completion
- 4 Oct 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for new ways to treat certain types of advanced and/or metastatic solid tumors.
The main goal of this study is to learn about the safety of different doses of MK-4884 and if participants tolerate them.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-4884 Dose Escalation Schedule A | Experimental | Drug: MK-4884Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met. |
| MK-4884 Dose Escalation Schedule B | Experimental | Drug: MK-4884Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has a histologically or cytologically confirmed diagnosis of 1 of the following unresectable (locally advanced) and/or advanced (metastatic) solid tumors:
- Colorectal carcinoma (CRC)
- Renal cell carcinoma (RCC) that contains a clear cell component (with or without sarcomatoid and/or rhabdoid features)
- Nonsquamous non-small cell lung cancer (NSCLC)
- Biliary tract cancer (BTC) (intra-or extrahepatic cholangiocarcinoma (CCA)) or gallbladder cancer (GBC)
Key exclusion criteria (9 listed)
- Has gastrointestinal malabsorption, a surgical procedure or a condition that could affect the absorption of the study drug
- Has a history of clinically significant cardiac, cardiovascular and/or cerebrovascular disease
- Has a serious nonhealing wound, ulcer, or bone fracture
- Has an active infection(s) requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-4884Oral Administration | Drug | MK-4884 Dose Escalation Schedule A, MK-4884 Dose Escalation Schedule B |
Primary outcome
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Time frame: Up to approximately 21 days
DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 39 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 39 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE will be reported.
5 secondary outcomes
Area Under the Concentration-Time Curve (AUC) of MK-4884
Time frame: At designated timepoints (up to approximately 15 days)
Maximum Plasma Concentration (Cmax) of MK-4884
Time frame: At designated timepoints (up to approximately 15 days)
Trough Plasma Concentration (Ctrough) of MK-4884
Time frame: At designated timepoints (up to approximately 39 months)
Time to Maximum Plasma Concentration (Tmax) of MK-4884
Time frame: At designated timepoints (up to approximately 15 days)
Apparent Terminal Half-life (t½) of MK-4884
Time frame: At designated timepoints (up to approximately 15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Malignant Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-4884 in people with Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland, United States, Canada, Israel, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) (time frame: Up to approximately 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.