A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)

Phase 1

Recruiting

• Conditions: Malignant Neoplasm; Advanced Solid Tumors
• Interventions: Biological: MK-3120

• Registration Number: NCT06818643
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Study First Posted: 2025-02-10
• Study Start: 2025-03-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-05-31
• Primary Completion: 2028-01-28
• Study Completion: 2028-01-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Has a confirmed advanced (unresectable and/or metastatic) solid tumor
• Has measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
• Has archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided
• Who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
• Who has history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before intervention allocation/randomization
• Has adequate organ function

Exclusion Criteria

• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled significant cardiovascular disease or cerebrovascular disease
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
• Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the start of study intervention
• Has received prior radiotherapy within 2 weeks of start of study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has active infection requiring systemic therapy
• Has concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA) infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 Dose level 1	MK-3120	Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm.
Arm 2 Dose level 2	MK-3120	Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to ~ 30 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.
Number of Participants Who Experience an Adverse Event (AE)	Up to ~ 30 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.

Secondary Outcome Measures

Name	Time	Method
Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator	Up to ~ 34 months	OR 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 using RECIST 1.1. OR as assessed by the investigator based on RECIST 1.1 will be presented.
Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator	Up to ~ 34 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 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 based on RECIST 1.1 will be presented.
Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator	Up to ~ 34 months	PFS is defined as the time from the first dose of study treatment to the first documented progressive disease (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 based on RECIST 1.1 will be presented.
Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator	Up to ~ 34 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 based on RECIST 1.1 will be presented.
Area Under the Concentration (AUC) of MK-3120	Pre dose and at specified time points up to approximately 4 months	Blood samples will be collected to determine the AUC of MK-3120.
Minimum Concentration (Cmin) of MK-3120	Pre dose and at specified time points up to approximately 4 months	Blood samples will be collected to determine the Cmin of MK-3120.
Maximum Concentration (Cmax) of MK-3120	Pre dose and at specified time points up to approximately 4 months	Blood samples will be collected to determine the Cmax of MK-3120.

Trial Locations

Locations (13)

Severance Hospital Yonsei University Health System ( Site 0151); 🇰🇷 Seoul, Korea, Republic of

Radboudumc ( Site 0091); 🇳🇱 Nijmegen, Gelderland, Netherlands

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090); 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Pontificia Universidad Catolica de Chile ( Site 0032); 🇨🇱 Santiago., Region M. De Santiago, Chile

Centro de Estudios Clínicos SAGA ( Site 0033); 🇨🇱 Santiago, Region M. De Santiago, Chile

FALP ( Site 0031); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradford Hill Centro de Investigaciones Clinicas ( Site 0030); 🇨🇱 Santiago, Region M. De Santiago, Chile

Peking University First Hospital ( Site 0180); 🇨🇳 Beijing, Beijing, China

Rambam Health Care Campus ( Site 0082); 🇮🇱 Haifa, Israel

Rabin Medical Center ( Site 0081); 🇮🇱 Petah Tikva, Israel

Sheba Medical Center ( Site 0080); 🇮🇱 Ramat Gan, Israel

Asan Medical Center ( Site 0153); 🇰🇷 Seoul, Korea, Republic of

National Taiwan University Hospital ( Site 0160); 🇨🇳 Taipei, Taiwan