MK-2010
BiologicalAdministered as an intravenous (IV) infusion.
Other names: LM-299
NCT Number: NCT07793942
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 means the cancer has spread nearby or to other parts in the body and cannot be removed with surgery.
In this trial, researchers want to learn if the trial medicine called MK-2010, given alone or with other treatments, can treat advanced solid tumors. MK-2010 is designed to help the immune system fight cancer.
The goals of this trial are to learn:
* About the safety of MK-2010 as monotherapy and in combinations 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 as monotherapy and in combination respond to treatment. Respond means the cancer gets smaller or goes away.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered as an intravenous (IV) infusion.
Other names: LM-299
Administered intravenously as 400 mg every 6 weeks.
Other names: MK-3475, Keytruda
Administered intravenously per approved product label.
Other names: 5-FU, Fluorouracil
Administered intravenously per approved product label.
Administered intravenously per approved product label.
Administered orally as 120 mg daily.
Other names: MK-6482, PT2977
Administered intravenously per approved product label.
Administered intravenously per approved product label.
Administered intravenously per approved product label.
Administered intravenously per approved product label.
Administered intravenously per approved product label.
Administered intravenously per approved product label.
Administered per approved product label as rescue medication.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 28 days
DLT is defined as any drug-related adverse event (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 24 months
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 48 months
For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response 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: Predose and at designated time points up to approximately 24 months
Blood samples will be collected to determine the AUC0-last of MK-2010.
Time frame: Predose and at designated time points up to approximately 24 months
Blood samples will be collected to determine the AUC0-tau of MK-2010.
Time frame: Predose and at designated time points up to approximately 24 months
Blood samples will be collected to determine Ctrough of MK-2010.
Time frame: Predose and at designated time points up to approximately 24 months
Blood samples will be collected to determine Cmax of MK-2010.
Time frame: Predose and at designated time points up to approximately 24 months
Blood samples will be collected to determine ADAs of MK-2010.
Merck Sharp & Dohme LLC
Industry
A Phase 2, Open-label Clinical Study to Evaluate the Safety and Efficacy of MK-2010 as Monotherapy and in Combination
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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