Advanced Solid Tumors, Malignant Neoplasm
Conditions
Brief summary
Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids. The main goal of this study is to learn about the safety of MK-3120 and if people tolerate it.
Interventions
BIOLOGICALMK-3120
IV infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments * If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART) * If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load * If hepatitis C virus (HCV) infected, must have undetectable HCV viral load
Exclusion criteria
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has uncontrolled significant cardiovascular disease or cerebrovascular disease * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage * Is HIV-positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Known additional malignancy that is progressing or has required active treatment within the past 2 years * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active infection requiring systemic therapy, with exceptions * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has HBV or HCV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 43 months | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 42 months | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator | Up to approximately 72 months | ORR is defined as the percentage of participants who had 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) as assessed by the investigator per RECIST 1.1. |
| Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator | Up to approximately 72 months | For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator per RECIST 1.1 will be presented. |
| Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator | Up to approximately 72 months | PFS is defined as the time from the first dose of study treatment to the first documented PD or death due to any cause, whichever occurs first will be assessed by the investigator using RECIST 1.1. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator per RECIST 1.1 will be presented. |
| Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator | Up to approximately 72 months | OS is defined as the time from the first dose of study treatment to death due to any cause as assessed by the investigator per RECIST 1.1 will be presented. |
| Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC) | At specified time points up to approximately 43 months | Blood samples will be collected to determine the AUC of MK-3120 ADC. |
| AUC of MK-3120 Total Antibody (TAb) | At specified time points up to approximately 43 months | Blood samples will be collected to determine the AUC of MK-3120 TAb |
| AUC of MK-3120 Free Payload | At specified time points up to approximately 43 months | Blood samples will be collected to determine the AUC of MK-3120 free payload. |
| Maximum Concentration (Cmax) of MK-3120 ADC | At specified time points up to approximately 43 months | Blood samples will be collected to determine the Cmax of MK-3120 ADC. |
| Cmax of MK-3120 TAb | At specified time points up to approximately 43 months | Blood samples will be collected to determine the Cmax of MK-3120 TAb. |
| Cmax of MK-3120 Free Payload | At specified time points up to approximately 43 months | Blood samples will be collected to determine the Cmax of MK-3120 free payload. |
| Minimum Concentration (Cmin) of MK-3120 ADC | At specified time points up to approximately 43 months | Blood samples will be collected to determine the Cmin of MK-3120 ADC. |
| Cmin of MK-3120 TAb | At specified time points up to approximately 43 months | Blood samples will be collected to determine the Cmin of MK-3120 TAb. |
| Cmin of MK-3120 Free Payload | At specified time points up to approximately 43 months | Blood samples will be collected to determine the Cmin of MK-3120 free payload. |
Countries
Chile, China, France, Israel, Japan, Netherlands, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed