Clinical trial NCT06818643: A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)
Official title: A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Malignant Neoplasm
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~ 30 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to ~ 30 months
Secondary outcomes:
measure: Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator
timeFrame: Up to ~ 34 months
measure: Duration Of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator
timeFrame: Up to ~ 34 months
measure: Progression-free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator
timeFrame: Up to ~ 34 months
measure: Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator
timeFrame: Up to ~ 34 months
measure: Area Under the Concentration (AUC) of MK-3120
timeFrame: Pre dose and at specified time points up to approximately 4 months
measure: Minimum Concentration (Cmin) of MK-3120
timeFrame: Pre dose and at specified time points up to approximately 4 months
measure: Maximum Concentration (Cmax) of MK-3120
timeFrame: Pre dose and at specified time points up to approximately 4 months
Other outcomes:
Locations:
city: Santiago.
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0032)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA ( Site 0033)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP ( Site 0031)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)
state: Region M. De Santiago
city: Beijing
country: China
facility: Peking University First Hospital ( Site 0180)
state: Beijing
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0082)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0081)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0080)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0151)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0153)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0152)
city: Nijmegen
country: Netherlands
facility: Radboudumc ( Site 0091)
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090)
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum ( Site 0092)
state: Zuid-Holland
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)
state: Cataluna
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0160)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: