A Clinical Trial of MK-2010 With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Solid Tumors (MK-2010)

Condition(s) studied

Investigational drug(s) / intervention(s)

MK-2010: Administered as an intravenous (IV) infusion

Sacituzumab tirumotecan: Administered as an IV infusion

Histamine H1 Receptor Antagonist: Administered as a premedication per the approved product label

Histamine H2 Receptor Antagonist: Administered as a premedication per the approved product label

Acetaminophen (or equivalent): Administered as a premedication per the approved product label

Dexamethasone (or equivalent): Administered as a premedication per the approved product label

Steroid mouthwash (dexamethasone or equivalent): Administered orally per the approved product label as a rescue medication

Epinephrine: Administered for emergency use per the approved product label

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Number of Participants Who Experience an Adverse Event (AE) — 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) — 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 — 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) — 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).

Trial sites (4)

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