MK-2010
BiologicalAdministered as an intravenous (IV) infusion
Other names: LM-299
NCT Number: NCT07785609
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.
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 as an IV infusion
Other names: 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
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.
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.
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.
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).
Time frame: Up to approximately 60 months
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: Predose and at designated time points post-dose (up to approximately 24 months)
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)
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)
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)
Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-2010.
Merck Sharp & Dohme LLC
Industry
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
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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