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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516817-19-00 | Registry Identifier | EU CT | |
| U1111-1311-1904 | Registry Identifier | UTN | |
| jRCT2031250198 | Registry Identifier | Japan Registry of Clinical Trial (jRCT) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Dose level 1 | Experimental | Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm. |
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| Arm 2 Dose level 2 | Experimental | Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-3120 | Biological | IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 43 months |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator | 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. | Up to approximately 72 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham ( Site 1005) | Recruiting | Birmingham | Alabama | 35249 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator | 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. | Up to approximately 72 months |
| Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator | 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. | Up to approximately 72 months |
| Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator | 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. | Up to approximately 72 months |
| Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC) | Blood samples will be collected to determine the AUC of MK-3120 ADC. | At specified time points up to approximately 43 months |
| AUC of MK-3120 Total Antibody (TAb) | Blood samples will be collected to determine the AUC of MK-3120 TAb | At specified time points up to approximately 43 months |
| AUC of MK-3120 Free Payload | Blood samples will be collected to determine the AUC of MK-3120 free payload. | At specified time points up to approximately 43 months |
| Maximum Concentration (Cmax) of MK-3120 ADC | Blood samples will be collected to determine the Cmax of MK-3120 ADC. | At specified time points up to approximately 43 months |
| Cmax of MK-3120 TAb | Blood samples will be collected to determine the Cmax of MK-3120 TAb. | At specified time points up to approximately 43 months |
| Cmax of MK-3120 Free Payload | Blood samples will be collected to determine the Cmax of MK-3120 free payload. | At specified time points up to approximately 43 months |
| Minimum Concentration (Cmin) of MK-3120 ADC | Blood samples will be collected to determine the Cmin of MK-3120 ADC. | At specified time points up to approximately 43 months |
| Cmin of MK-3120 TAb | Blood samples will be collected to determine the Cmin of MK-3120 TAb. | At specified time points up to approximately 43 months |
| Cmin of MK-3120 Free Payload | Blood samples will be collected to determine the Cmin of MK-3120 free payload. | At specified time points up to approximately 43 months |
| University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003) | Recruiting | Miami | Florida | 33136 | United States |
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| John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009) | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| NEXT Oncology ( Site 1010) | Recruiting | Austin | Texas | 78758 | United States |
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| NEXT Oncology ( Site 1011) | Recruiting | Houston | Texas | 77054 | United States |
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| NEXT Oncology ( Site 1012) | Recruiting | Irving | Texas | 75039 | United States |
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| Virginia Commonwealth University ( Site 1008) | Recruiting | Richmond | Virginia | 23219 | United States |
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| Centro de Estudios Clínicos SAGA ( Site 0033) | Recruiting | Santiago | Region M. de Santiago | 7500653 | Chile |
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| FALP ( Site 0031) | Recruiting | Santiago | Region M. de Santiago | 7500921 | Chile |
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| Pontificia Universidad Catolica de Chile ( Site 0032) | Recruiting | Santiago | Region M. de Santiago | 8330032 | Chile |
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| Bradford Hill Centro de Investigaciones Clinicas ( Site 0030) | Recruiting | Santiago | Region M. de Santiago | 8420383 | Chile |
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| Peking University First Hospital ( Site 0180) | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Chongqing Cancer Hospital ( Site 0186) | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Hunan Cancer Hospital ( Site 0181) | Recruiting | Changsha | Hunan | 410013 | China |
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| The First Hospital of Jilin University ( Site 0185) | Recruiting | Changchun | Jilin | 130021 | China |
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| West China Hospital Sichuan University ( Site 0187) | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Institut Paoli Calmettes ( Site 0053) | Recruiting | Marseille | Bouches-du-Rhone | 13273 | France |
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| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0054) | Recruiting | Rennes | Ille-et-Vilaine | 35000 | France |
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| Centre Oscar Lambret ( Site 0051) | Recruiting | Lille | Nord | 59000 | France |
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| Gustave Roussy ( Site 0050) | Recruiting | Villejuif | Val-de-Marne | 94800 | France |
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| Rambam Health Care Campus ( Site 0082) | Recruiting | Haifa | 3109601 | Israel |
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| Rabin Medical Center ( Site 0081) | Recruiting | Petah Tikva | 4941492 | Israel |
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| Sheba Medical Center ( Site 0080) | Recruiting | Ramat Gan | 5265601 | Israel |
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| National Cancer Center Hospital East ( Site 0190) | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
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| Cancer Institute Hospital of JFCR ( Site 0192) | Recruiting | Koto | Tokyo | 135-8550 | Japan |
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| Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0191) | Recruiting | Osaka | 541-8567 | Japan |
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| Radboudumc ( Site 0091) | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
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| Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090) | Recruiting | Amsterdam | North Holland | 1066 CX | Netherlands |
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| Amsterdam UMC, locatie VUmc ( Site 0093) | Recruiting | Amsterdam | North Holland | 1081HV | Netherlands |
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| Erasmus Medisch Centrum ( Site 0092) | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
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| Pratia Poznan ( Site 0105) | Recruiting | Poznan | Greater Poland Voivodeship | 60-192 | Poland |
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| Pratia MCM Krakow ( Site 0106) | Recruiting | Krakow | Lesser Poland Voivodeship | 30-727 | Poland |
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| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0104) | Recruiting | Koszalin | West Pomeranian Voivodeship | 75-581 | Poland |
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| Seoul National University Hospital ( Site 0150) | Recruiting | Seoul | 03080 | South Korea |
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| Severance Hospital Yonsei University Health System ( Site 0151) | Recruiting | Seoul | 03722 | South Korea |
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| Asan Medical Center ( Site 0153) | Recruiting | Seoul | 05505 | South Korea |
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| Samsung Medical Center ( Site 0152) | Recruiting | Seoul | 06351 | South Korea |
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| Institut Català d'Oncologia - L'Hospitalet ( Site 0113) | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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| HOSPITAL CLÍNIC DE BARCELONA ( Site 0112) | Recruiting | Barcelona | Catalonia | 08036 | Spain |
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| Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0111) | Recruiting | Madrid | Madrid, Comunidad de | 28040 | Spain |
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| Hospital Universitario Virgen de la Victoria ( Site 0114) | Recruiting | Málaga | 29016 | Spain |
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| Chi Mei Medical Center ( Site 0162) | Recruiting | Tainan | Tainan | 71004 | Taiwan |
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| National Cheng Kung University Hospital ( Site 0161) | Recruiting | Tainan | 704 | Taiwan |
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| National Taiwan University Hospital ( Site 0160) | Recruiting | Taipei | 10002 | Taiwan |
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| Ankara Bilkent Şehir Hastanesi. ( Site 0131) | Recruiting | Çankaya | Ankara | 06800 | Turkey (Türkiye) |
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| Ankara University Health Practice and Research Hospitals ( Site 0134) | Recruiting | Ankara | 06620 | Turkey (Türkiye) |
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| Hacettepe Universite Hastaneleri ( Site 0130) | Recruiting | Ankara | 6230 | Turkey (Türkiye) |
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| Koc University, School of Medicine ( Site 0133) | Recruiting | Istanbul | 34010 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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