A Phase 2 interventional study of MK-2010 and Sacituzumab tirumotecan in Advanced Solid Tumors and Malignant Neoplasm, sponsored by Merck Sharp & Dohme LLC. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
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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:
10,824 studies on the registry are indexed under Neoplasms; 2,325 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 7,706 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive MK-2010 in combination with sac-TMT.
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
Participants will receive MK-2010 in combination with sac-TMT at the dose determined in Part 1.
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
Administered as an intravenous (IV) infusion
Also known as: LM-299
Administered as an IV infusion
Also known as: sac-TMT, MK-2870, SKB264
Administered as a premedication per the approved product label
Administered as a premedication per the approved product label
Administered as a premedication per the approved product label
Administered as a premedication per the approved product label
Administered orally per the approved product label as a rescue medication
Administered for emergency use per the approved product label
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to approximately 60 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose and at designated time points post-dose (up to approximately 24 months)
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started Oct 2026 (actual). Primary completion is estimated for Sep 2031, 59 months after the start.
Of 179 industry-sponsored phase 2 interventional studies under Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 68. This study's planned 59 months is above that.
Counting every sponsor, half of 514 studies reached it within 52 months; a quarter within 33 and three quarters within 92.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
Start moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, last on Oct 15, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Anti-PD-1/Anti-VEGF Bispecific Antibody MK-2010