Clinical trial NCT06242691: Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)
Official title: A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 304
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: The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal junction (GEJ) cancer, esophageal cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma who have received, or been intolerant to, all treatments known to confer clinical benefit. Part 1 of the study will be a dose escalation to determine the maximum tolerated dose (MTD). Part 2 will evaluate safety and efficacy of MK-1200 at 2 different doses


Eligibility criteria: Inclusion Criteria:

* Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma
* Participants who experienced Adverse Events (AEs) due to previous anticancer therapies must have recovered to \< Grade 1 or baseline
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
* Participants with a history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
* Received and progressed on or after 1 or 2 prior lines of therapy

Exclusion Criteria:

* Active severe digestive disease
* History of acute myocardial infarction; unstable angina; stroke or transient ischemic attack within 6 months prior to the first dose of study intervention
* Diabetes or hypertension that cannot be controlled by medication
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* 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
* Have not adequately recovered from major surgery or have ongoing surgical complications

Primary outcomes:
measure: Number of Participants who Experience One or More Dose-Limiting Toxicities (DLTs)
timeFrame: Up to approximately 28 days
measure: Number of Participants who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 16 months
measure: Number of Participants who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 15 months
Secondary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 16 months
measure: ORR per RECIST 1.1 as Assessed by Investigator
timeFrame: Up to approximately 16 months
measure: Area under the curve (AUC) of MK-1200
timeFrame: Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to 15 months): predose and 0.5 hours postdose. Cycle is 14 days.
measure: Minimum Concentration (Cmin) of MK-1200
timeFrame: Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to 15 months): predose and 0.5 hours postdose. Cycle is 14 days.
measure: Maximum Concentration (Cmax) of MK-1200
timeFrame: Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to 15 months): predose and 0.5 hours postdose. Cycle is 14 days.
measure: Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 16 months
measure: DOR per RECIST 1.1 as Assessed by Investigator
timeFrame: Up to approximately 16 months
measure: Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 16 months
measure: PFS per RECIST 1.1 as Assessed by Investigator
timeFrame: Up to approximately 16 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 16 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
state: Kentucky
city: Grand Rapids
country: United States
facility: START Midwest ( Site 0014)
state: Michigan
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics (START) ( Site 0005)
state: Texas
city: West Valley City
country: United States
facility: START Mountain Region ( Site 0015)
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System-Hematology-Oncology ( Site 0009)
state: Virginia
city: Melbourne
country: Australia
facility: The Alfred Hospital ( Site 0103)
state: Victoria
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0301)
state: Region M. De Santiago
city: Beijing
country: China
facility: Beijing Cancer hospital-Digestive Oncology ( Site 0401)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital-oncology department ( Site 0409)
state: Fujian
city: Huai'an
country: China
facility: First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)
state: Jiangsu
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0602)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 0604)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center-Oncology ( Site 0603)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0605)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0601)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: