Advanced Solid TumorsPhase 2NCT07785609
A Clinical Trial of MK-2010 With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Solid Tumors (MK-2010)
A Phase 2 study testing MK-2010, Sacituzumab tirumotecan and Histamine H1 Receptor Antagonist in people with Advanced Solid Tumors and Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 4 sites in 3 countries.
Trial summary
Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced may mean the cancer has spread to nearby or other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Malignant Neoplasm
- What is being tested?
- MK-2010, Sacituzumab tirumotecan and Histamine H1 Receptor Antagonist
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Oct 2026to 30 Sep 2031
- Phase
- Phase 2
- 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART)
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks
- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
- Has adequate organ function
Who cannot join
- If prior anticancer therapy is allowed, participants are excluded if they received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before allocation
- Has received prior locoregional therapy within 2 weeks of start of study intervention, or has ongoing locoregional treatment-related toxicities
- Is currently receiving any anticoagulants
- Was discontinued from prior immunotherapy due to a Grade ≥3 immune-related adverse event (irAE)
- 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 intervention
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
Show all 21Show fewer
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
- Active or ongoing stomatitis and/or mucositis of any grade
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis
- Has history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or from central venous access device placement, or has ongoing surgical complications
- Has clinically significant hemoptysis, hematemesis, or tumor bleeding within 4 weeks before the first dose of study intervention
- Has any clinically significant or life-threatening bleeding event that occurred within 3 months prior to the first dose of the study intervention
- Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
- Has any history of myocarditis or cardiomyopathy
- Has a current or history of severe cardiovascular and cerebrovascular diseases
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Switzerland2 sites, 2 recruiting
- Recruiting
Ospedale Regionale Bellinzona e Valli ( Site 1102)
Bellinzona, Canton Ticino, 6500
Study Coordinator, +41918119111
- Recruiting
Cantonal Hospital St.Gallen ( Site 1100)
Sankt Gallen, 9007
Study Coordinator, +41714941111
United States1 site, 1 recruiting
- Recruiting
START San Antonio ( Site 0220)
San Antonio, Texas, 78229
Study Coordinator, 210-593-5265
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital ( Site 2300)
Hong Kong
Study Coordinator, 39103339
About this study
Official title: Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of MK-2010 in Combination With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Advanced Solid Tumors
Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced may mean the cancer has spread to nearby or other parts of the body. The cancer may not be able to be treated with surgery or radiation, which uses beams of intense energy (like X-rays) to shrink or get rid of tumors. Some cancers may not have gone away or came back after previous treatment. MK-2010, the trial treatment, is designed to help the immune system fight cancer.
This trial will look at MK-2010 when given with another trial treatment called sacituzumab tirumotecan (sac-TMT). Sac-TMT is an antibody-drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
Read more
The goals of this trial are to learn:
- About the safety of MK-2010 with sac-TMT and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems.
- How many participants who receive MK-2010 with sac-TMT have the cancer respond to treatment. Respond means the cancer gets smaller or goes away.
- Conditions
- Advanced Solid Tumors, Malignant Neoplasm
- Being tested
- MK-2010, Sacituzumab tirumotecan, Histamine H1 Receptor Antagonist, Histamine H2 Receptor Antagonist, Acetaminophen (or equivalent)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2010Biological
Also called LM-299
Administered as an intravenous (IV) infusion
Sacituzumab tirumotecanBiological
Also called sac-TMT, MK-2870, SKB264
Administered as an IV infusion
Histamine H1 Receptor AntagonistDrug
Administered as a premedication per the approved product label
Histamine H2 Receptor AntagonistDrug
Administered as a premedication per the approved product label
Acetaminophen (or equivalent)Drug
Administered as a premedication per the approved product label
Dexamethasone (or equivalent)Drug
Administered as a premedication per the approved product label
Steroid mouthwash (dexamethasone or equivalent)Drug
Administered orally per the approved product label as a rescue medication
EpinephrineDrug
Administered for emergency use per the approved product label
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Safety Lead-In Cohort | Experimental | Participants will receive MK-2010 in combination with sac-TMT. Receives: Biological: MK-2010; Biological: Sacituzumab tirumotecan; Drug: Histamine H1 Receptor Antagonist; Drug: Histamine H2 Receptor Antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent); Drug: Epinephrine |
| Part 2: Signal-Finding Cohorts | Experimental | Participants will receive MK-2010 in combination with sac-TMT at the dose determined in Part 1. Receives: Biological: MK-2010; Biological: Sacituzumab tirumotecan; Drug: Histamine H1 Receptor Antagonist; Drug: Histamine H2 Receptor Antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent); Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 27 months
Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Part 1 Only)
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.
Measured: Up to approximately 28 days
Number of Participants Who Discontinued Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 24 months
Objective Response Rate (ORR)
ORR is defined as a confirmed complete response (CR: Disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Measured: Up to approximately 60 months
Secondary outcomes (5)
Duration of Response (DOR)
DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 60 months
Area Under the Concentration-Time Curve (AUC) of MK-2010
Blood samples will be collected at designated timepoints to estimate the AUC of MK-2010.
Measured: Predose and at designated time points post-dose (up to approximately 24 months)
Trough Concentration (Ctrough) of MK-2010
Blood samples will be collected at designated timepoints to estimate the Ctrough of MK-2010.
Measured: Predose and at designated time points post-dose (up to approximately 24 months)
Maximum Plasma Concentration (Cmax) of MK-2010
Blood samples will be collected at designated timepoints to estimate the Cmax of MK-2010.
Measured: Predose and at designated time points post-dose (up to approximately 24 months)
Incidence of Antidrug Antibodies (ADA) to MK-2010
Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-2010.
Measured: Predose and at designated time points post-dose (up to approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start7 Oct 2026
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT07785609
- Sponsor's protocol ID
- 2010-003
- Other IDs
- MK-2010-003, U1111-1334-8253, 2026-525481-21-00
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 15 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of MK-2010 in Combination With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07785609
- Acronym / sponsor ID
- 2010-003
- Conditions
- Advanced Solid Tumors, Malignant Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 25 Aug 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 solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced may mean the cancer has spread to nearby or other parts of the body. The cancer may not be able to be treated with surgery or radiation, which uses beams of intense energy (like X-rays) to shrink or get rid of tumors. Some cancers may not have gone away or came back after previous treatment. MK-2010, the trial treatment, is designed to help the immune system fight cancer.
This trial will look at MK-2010 when given with another trial treatment called sacituzumab tirumotecan (sac-TMT). Sac-TMT is an antibody-drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
The goals of this trial are to learn:
- About the safety of MK-2010 with sac-TMT and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems.
- How many participants who receive MK-2010 with sac-TMT have the cancer respond to treatment. Respond means the cancer gets smaller or goes away.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Safety Lead-In Cohort | Experimental | Biological: MK-2010, Biological: Sacituzumab tirumotecan, Drug: Histamine H1 Receptor Antagonist, Drug: Histamine H2 Receptor Antagonist, Drug: Acetaminophen (or equivalent), Drug: Dexamethasone (or equivalent), Drug: Steroid mouthwash (dexamethasone or equivalent), Drug: EpinephrineParticipants will receive MK-2010 in combination with sac-TMT. |
| Part 2: Signal-Finding Cohorts | Experimental | Biological: MK-2010, Biological: Sacituzumab tirumotecan, Drug: Histamine H1 Receptor Antagonist, Drug: Histamine H2 Receptor Antagonist, Drug: Acetaminophen (or equivalent), Drug: Dexamethasone (or equivalent), Drug: Steroid mouthwash (dexamethasone or equivalent), Drug: EpinephrineParticipants will receive MK-2010 in combination with sac-TMT at the dose determined in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART)
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks
- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
- Has adequate organ function
Key exclusion criteria (21 listed)
- If prior anticancer therapy is allowed, participants are excluded if they received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before allocation
- Has received prior locoregional therapy within 2 weeks of start of study intervention, or has ongoing locoregional treatment-related toxicities
- Is currently receiving any anticoagulants
- Was discontinued from prior immunotherapy due to a Grade ≥3 immune-related adverse event (irAE)
- 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 intervention
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-2010Also: LM-299Administered as an intravenous (IV) infusion | Biological | Part 1: Safety Lead-In Cohort, Part 2: Signal-Finding Cohorts |
| Sacituzumab tirumotecanAlso: sac-TMT, MK-2870, SKB264Administered as an IV infusion | Biological | Part 1: Safety Lead-In Cohort, Part 2: Signal-Finding Cohorts |
| Histamine H1 Receptor AntagonistAdministered as a premedication per the approved product label | Drug | Part 1: Safety Lead-In Cohort, Part 2: Signal-Finding Cohorts |
| Histamine H2 Receptor AntagonistAdministered as a premedication per the approved product label | Drug | Part 1: Safety Lead-In Cohort, Part 2: Signal-Finding Cohorts |
| Acetaminophen (or equivalent)Administered as a premedication per the approved product label | Drug | Part 1: Safety Lead-In Cohort, Part 2: Signal-Finding Cohorts |
| Dexamethasone (or equivalent)Administered as a premedication per the approved product label | Drug | Part 1: Safety Lead-In Cohort, Part 2: Signal-Finding Cohorts |
| Steroid mouthwash (dexamethasone or equivalent)Administered orally per the approved product label as a rescue medication | Drug | Part 1: Safety Lead-In Cohort, Part 2: Signal-Finding Cohorts |
| EpinephrineAdministered for emergency use per the approved product label | Drug | Part 1: Safety Lead-In Cohort, Part 2: Signal-Finding Cohorts |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 27 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Part 1 Only)
Time frame: Up to approximately 28 days
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.
Number of Participants Who Discontinued Study Intervention Due to an AE
Time frame: Up to approximately 24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Objective Response Rate (ORR)
Time frame: Up to approximately 60 months
ORR is defined as a confirmed complete response (CR: Disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
5 secondary outcomes
Duration of Response (DOR)
Time frame: Up to approximately 60 months
Area Under the Concentration-Time Curve (AUC) of MK-2010
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Trough Concentration (Ctrough) of MK-2010
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Maximum Plasma Concentration (Cmax) of MK-2010
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Incidence of Antidrug Antibodies (ADA) to MK-2010
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
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 15 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 Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-2010, Sacituzumab tirumotecan and Histamine H1 Receptor Antagonist in people with Advanced Solid Tumors and Malignant Neoplasm, run by Merck Sharp & Dohme LLC at 4 sites in 3 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 5 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: looking for participants now, as of the sponsor's last update on 15 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 4 sites in Switzerland, United States, Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 an Adverse Event (AE) (time frame: Up to approximately 27 months). The study lists 4 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 15 Oct 2026.