A Clinical Trial of MK-2010 With Sacituzumab Tirumotecan (Sac-TMT) in Participants With Solid Tumors (MK-2010)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
MK-2010
Biological/VaccineAdministered as an intravenous (IV) infusion
Sacituzumab tirumotecan
Biological/VaccineAdministered as an IV infusion
Histamine H1 Receptor Antagonist
DrugAdministered as a premedication per the approved product label
Histamine H2 Receptor Antagonist
DrugAdministered as a premedication per the approved product label
Acetaminophen (or equivalent)
DrugAdministered as a premedication per the approved product label
Dexamethasone (or equivalent)
DrugAdministered as a premedication per the approved product label
Steroid mouthwash (dexamethasone or equivalent)
DrugAdministered orally per the approved product label as a rescue medication
Epinephrine
DrugAdministered for emergency use per the approved product label
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Part 1: Safety Lead-In CohortExperimental treatment 8 interventions
Group B: Part 2: Signal-Finding CohortsExperimental treatment 8 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 days3
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 months4
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 monthsSecondary outcomes
1
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 months2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov