Metastatic Solid TumorsPhase 1NCT05853367
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
A Phase 1 study testing MK-0472, Pembrolizumab and MK-1084 in people with Metastatic Solid Tumors and Advanced Solid Tumors, run by Merck Sharp & Dohme LLC at 25 sites in 7 countries.
Trial summary
The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumors, Advanced Solid Tumors
- What is being tested?
- MK-0472, Pembrolizumab and MK-1084
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 6 Jul 2023to 24 Jun 2028
- 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
- The main inclusion criteria include but are not limited to the following:
- Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (>4 weeks) antiretroviral therapy (ART)
- Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing (tissue or blood) and have received, or been intolerant to, all available treatment known to confer clinical benefit
- Arm 2: Tumor types known to be sensitive to anti-programmed cell death 1 protein (PD-1)/ligand 1 (L1) therapies are eligible. Tumor types permitted include: melanoma, non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK)/ROS1 mutations, renal cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, MSI-high CRC, endometrial cancer, cervical cancer, small cell lung cancer, triple negative breast cancer, esophageal cancer, gastric cancer, biliary tract cancer, hepatocellular carcinoma, head and neck squamous cancer, cutaneous squamous cancer, anal squamous cancer, and mesothelioma
- Arm 3: Has histologically OR blood-based confirmation of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study
- Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- History of hyperparathyroidism or hypercalcemia
- Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease
- Has clinically significant cardiovascular disease
Show all 21Show fewer
- Bullous exfoliative skin disorders of any grade
- Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients
- Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing
- Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
- Has history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has history of allogeneic tissue/solid organ transplant
- Have not adequately recovered from major surgery or have ongoing surgical complications
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
Israel5 sites
Rambam Health Care Campus ( Site 0304)
Haifa, 3109601
Shaare Zedek Medical Center ( Site 0303)
Jerusalem, 9103102
Rabin Medical Center ( Site 0301)
Petah Tikva, 4941492
Sheba Medical Center ( Site 0300)
Ramat Gan, 5265601
Sourasky Medical Center ( Site 0302)
Tel Aviv, 6423906
United States4 sites
Northwestern Memorial Hospital ( Site 0002)
Chicago, Illinois, 60611
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)
Hackensack, New Jersey, 07601
The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
Louisville, Kentucky, 40202
Rutgers Cancer Institute of New Jersey ( Site 0005)
New Brunswick, New Jersey, 08901
Chile4 sites
Centro de Estudios Clínicos SAGA ( Site 0701)
Santiago, Region M. de Santiago, 7500653
Fundacion Arturo Lopez Perez ( Site 0700)
Santiago, Region M. de Santiago, 7500921
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)
Santiago, Region M. de Santiago, 8330034
Bradfordhill ( Site 0702)
Santiago, Region M. de Santiago, 8420383
Spain4 sites
Hospital Universitari Vall d'Hebron ( Site 0500)
Barcelona, 08035
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 0501)
L'Hospitalet de Llobregat, Catalonia, 08907
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0504)
Madrid, Madrid, Comunidad de, 28050
Hospital Virgen del Rocio ( Site 0503)
Seville, 41013
Canada3 sites
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)
Montreal, Quebec, H2X 0A9
Département clinique de médecine de laboratoire du CHUM ( Site 0104)
Montreal, Quebec, H3T 1E2
Princess Margaret Cancer Centre ( Site 0101)
Toronto, Ontario, M5G 2M9
Switzerland3 sites
Ospedale Regionale Bellinzona e Valli ( Site 0200)
Bellinzona, Canton Ticino, 6500
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Geneva, Canton of Geneva, 1211
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 0201)
Sankt Gallen, Canton of St. Gallen, 9000
Poland2 sites
Uniwersyteckie Centrum Kliniczne ( Site 0400)
Gdansk, Pomeranian Voivodeship, 80-214
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0401)
Warsaw, Masovian Voivodeship, 02-781
About this study
Official title: A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors.
The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.
- Conditions
- Metastatic Solid Tumors, Advanced Solid Tumors
- Being tested
- MK-0472, Pembrolizumab, MK-1084
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Src Homology-2 Domain Containing Protein Tyrosine Phosphatase-2 (SHP-2)
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0472Drug
Oral Administration
PembrolizumabBiological
Also called MK-3475, Keytruda®
IV infusion
MK-1084Drug
Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| MK-0472 | Experimental | Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation. Receives: Drug: MK-0472 |
| MK-0472 + Pembrolizumab | Experimental | Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation, plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years). Receives: Drug: MK-0472; Biological: Pembrolizumab |
| MK-0472 + MK-1084 | Experimental | Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens, plus MK-1084 via oral capsule until disease progression or withdrawal/discontinuation. Receives: Drug: MK-0472; Drug: MK-1084 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
DLT will be defined as any drug-related AE observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle.
Measured: At the end of Cycle 1 (each cycle is 21 days)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE's will be reported.
Measured: Up to approximately 60 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start6 Jul 2023
- Primary completion24 Jun 2028 (estimated)
- Study completion24 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
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
- NCT05853367
- Sponsor's protocol ID
- 0472-001
- Other IDs
- MK-0472-001, 2024-516006-32-00, U1111-1310-1179
- Status last verified
- Aug 2026
- First submitted
- 2 May 2023
- Last updated
- 7 Aug 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors.
- ClinicalTrials.gov ID
- NCT05853367
- Acronym / sponsor ID
- 0472-001
- Conditions
- Metastatic Solid Tumors, Advanced Solid Tumors
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Src Homology-2 Domain Containing Protein Tyrosine Phosphatase-2 (SHP-2)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 24 Jun 2028 (estimated)
- Study completion
- 24 Jun 2028 (estimated)
- First posted
- 10 May 2023 (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.
The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MK-0472 | Experimental | Drug: MK-0472Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation. |
| MK-0472 + Pembrolizumab | Experimental | Drug: MK-0472, Biological: PembrolizumabParticipants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation, plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years). |
| MK-0472 + MK-1084 | Experimental | Drug: MK-0472, Drug: MK-1084Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens, plus MK-1084 via oral capsule until disease progression or withdrawal/discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (>4 weeks) antiretroviral therapy (ART)
- Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing (tissue or blood) and have received, or been intolerant to, all available treatment known to confer clinical benefit
Key exclusion criteria (21 listed)
- Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study
- Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- History of hyperparathyroidism or hypercalcemia
- Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease
- Has clinically significant cardiovascular 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-0472Oral Administration | Drug | MK-0472, MK-0472 + MK-1084, MK-0472 + Pembrolizumab |
| PembrolizumabAlso: MK-3475, Keytruda®IV infusion | Biological | MK-0472 + Pembrolizumab |
| MK-1084Oral Administration | Drug | MK-0472 + MK-1084 |
Primary outcome
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: At the end of Cycle 1 (each cycle is 21 days)
DLT will be defined as any drug-related AE observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle.
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 60 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE's will be reported.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time frame: Up to approximately 60 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
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 7 Aug 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-0472, Pembrolizumab and MK-1084 in people with Metastatic Solid Tumors and Advanced Solid Tumors, run by Merck Sharp & Dohme LLC at 25 sites in 7 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 8 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Israel, United States, Chile, Spain, Canada and 2 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (time frame: At the end of Cycle 1 (each cycle is 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 7 Aug 2026.